Advanced Malignant Solid NeoplasmPhase 2NCT05564377
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
A Phase 2 study testing Alpelisib, Binimetinib and Biopsy Procedure in people with Advanced Malignant Solid Neoplasm and Anatomic Stage III Breast Cancer AJCC v8, run by National Cancer Institute (NCI) at 484 sites in 2 countries.
Trial summary
This ComboMATCH patient screening trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. Patients with solid tumors that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
- What is being tested?
- Alpelisib, Binimetinib and Biopsy Procedure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,900 participants
- Where
- 484 sitesin 2 countries
- Study dates
- 7 Apr 2023to 1 Jul 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient must have measurable disease
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-2 OR patient must have Lansky performance status of >= 50% or Karnofsky performance status of >= 50%
- Patient must be deemed potentially eligible for a ComboMATCH Treatment Trial as assessed by the enrolling provider
- All patients must have sequencing results available from a National Cancer Institute (NCI) credentialed Designated Laboratory (DL)
- Patients must have locally advanced or advanced histologically documented solid tumors requiring therapy and meet one of the following criteria:
- Patients must have progressed on at least one line of standard systemic therapy OR
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- Patients whose disease has no standard treatment that has been shown to prolong overall survival
- Patient must meet one of the following requirements:
- Patients 18 years and older who have tumor amenable to minimal risk image-guided or direct vision biopsy and must be willing and able to undergo a tumor biopsy to obtain samples for research if the patient is to enroll in a ComboMATCH treatment trial OR
- Patients 18 years and older who do not have disease that is biopsiable at minimal risk to the patient must confirm availability of an archival tumor tissue specimen for submission for research if the patient enrolls to a ComboMATCH Treatment Trial. This tumor tissue must meet the following criteria:
- Tissue must have been collected within 12 months prior to registration to the EAY191 Registration Trial
- Patient must not have had a Response Evaluation Criteria in Solid Tumors (RECIST) response (complete response [CR] or partial response [PR]) to any intervening therapy after collection of the tissue
- Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be available OR
- Patients under 18 years old must confirm availability of an archival tumor tissue specimen for submission for research if patient enrolls to a ComboMATCH Treatment Trial. This tumor tissue must meet the following criteria:
- Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be available
- NOTE: See specific ComboMATCH Treatment Trial protocol for tissue collection and management instructions. Performance of the mandatory research biopsy or submission of pre-trial formalin-fixed paraffin-embedded (FFPE) and collection and submission of the blood specimens for the integrated studies will be performed under the consent authority of the specific treatment trial protocol to which the patient is registered. No procedures to collect specimens for research only are to be performed for patients registered to the EAY191 Registration Trial only
- NOTE: Each ComboMATCH Treatment Trial contains specific eligibility criteria. If patient is found to not be eligible for the assigned ComboMATCH Treatment Trial, indication of ineligibility will trigger re-evaluation and potential assignment to another Treatment Trial
Who cannot join
None listed.
Trial locations and contacts
484 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
304 sites in 2 countries
United States300 sites, 273 recruiting
- Recruiting
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, 96701
Site Public Contact, 808-539-2273, info@hawaiicancercare.com
Jeffrey L. Berenberg
- Recruiting
Pali Momi Medical Center
‘Aiea, Hawaii, 96701
Site Public Contact, 808-486-6000
Jeffrey L. Berenberg
- Recruiting
The Queen's Medical Center - West Oahu
‘Ewa Beach, Hawaii, 96706
Site Public Contact, rohta@queens.org
Jeffrey L. Berenberg
- Recruiting
Hendrick Medical Center
Abilene, Texas, 79601
Site Public Contact, 325-670-6340
Jose C. Velasco Di Domenico
- Recruiting
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu
Bernard Tawfik
- Recruiting
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Tareq Al baghdadi
- Recruiting
UPMC Altoona
Altoona, Pennsylvania, 16601
Site Public Contact, ecog.rss@jimmy.harvard.edu
Adam M. Brufsky
- Recruiting
Community Hospital of Anaconda
Anaconda, Montana, 59711
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Alaska Women's Cancer Care
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Alison K. Conlin
- Recruiting
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Site Public Contact, 800-865-1125, CancerAnswerLine@med.umich.edu
Anne F. Schott
- Recruiting
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
Site Public Contact, 920-364-3604, ResearchDept@thedacare.org
Matthias Weiss
- Recruiting
ThedaCare Regional Medical Center - Appleton
Appleton, Wisconsin, 54911
Site Public Contact, 920-364-3605, ResearchDept@thedacare.org
Matthias Weiss
- Recruiting
PCR Oncology
Arroyo Grande, California, 93420
Site Public Contact, 702-384-0013, research@sncrf.org
Khawaja S. Jahangir
- Recruiting
Cone Health MedCenter Asheboro
Asheboro, North Carolina, 27205
Site Public Contact, 336-832-0836, stacey.phelps@conehealth.com
Vinay K. Gudena
- Recruiting
Duluth Clinic Ashland
Ashland, Wisconsin, 54806
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
OhioHealth O'Bleness Hospital
Athens, Ohio, 45701
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Aine E. Clements
- Recruiting
Harold Alfond Center for Cancer Care
Augusta, Maine, 04330
Site Public Contact, 207-626-4855
Leslie S. Bradford
- Recruiting
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045
Site Public Contact, 720-848-0650
Bradley R. Corr
- Recruiting
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, 33180
Site Public Contact, 954-461-2180
Chukwuemeka (Emeka) V. Ikpeazu
- Recruiting
UH Seidman Cancer Center at UH Avon Health Center
Avon, Ohio, 44011
Site Public Contact, 800-641-2422
Alberto J. Montero
- Recruiting
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
Site Public Contact, 800-888-8823
Ranee Mehra
- Recruiting
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010
Site Public Contact, 847-842-4847
Antony Ruggeri
- Recruiting
Bronson Battle Creek
Battle Creek, Michigan, 49017
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122
Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org
Alberto J. Montero
- Active, not recruiting
Nebraska Medicine-Bellevue
Bellevue, Nebraska, 68123
- Recruiting
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714
Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Aruna C. Gowda
- Recruiting
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Site Public Contact, 218-333-5000, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
ThedaCare Cancer Care - Berlin
Berlin, Wisconsin, 54923
Site Public Contact, 920-364-3605, ResearchDept@thedacare.org
Matthias Weiss
- Recruiting
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
Site Public Contact, 301-319-2100
Jeremy G. Perkins
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Site Public Contact, 800-411-1222
A P. Chen
- Recruiting
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Tareq Al baghdadi
- Recruiting
Billings Clinic Cancer Center
Billings, Montana, 59101
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- Recruiting
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
Site Public Contact, gingerreeves@uabmc.edu
Rebecca C. Arend
- Recruiting
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Recruiting
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Site Public Contact, 208-381-2774, eslinget@slhs.org
Alison K. Conlin
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Site Public Contact, 617-636-5000, ContactUsCancerCenter@TuftsMedicalCenter.org
Francis W. Nugent
- Active, not recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Site Public Contact, 877-442-3324
Geoffrey I. Shapiro
- Recruiting
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Lafayette Family Cancer Center-EMMC
Brewer, Maine, 04412
Site Public Contact, 800-987-3005
Sarah J. Sinclair
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
University of Michigan - Brighton Center for Specialty Care
Brighton, Michigan, 48116
Site Public Contact, 800-865-1125
Anne F. Schott
- Recruiting
Ballad Health Cancer Care - Bristol
Bristol, Virginia, 24201
Site Public Contact, 423-431-5654, charles.mays@balladhealth.org
Asheesh Shipstone
- Recruiting
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
Site Public Contact, 484-476-2649, turzoe@mlhs.org
Paul B. Gilman
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Site Public Contact, 800-767-9355, askroswell@roswellpark.org
Ellis G. Levine
- Recruiting
Cone Health Cancer Center at Alamance Regional
Burlington, North Carolina, 27215
Site Public Contact, 336-832-0836, stacey.phelps@conehealth.com
Vinay K. Gudena
- Recruiting
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105
Site Public Contact, 414-302-2304, ncorp@aurora.org
Antony Ruggeri
- Recruiting
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
Illinois CancerCare-Canton
Canton, Illinois, 61520
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
Trinity Health Medical Center - Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
Aultman Health Foundation
Canton, Ohio, 44710
Site Public Contact, 330-363-7274, ClinicalReserachDept@aultman.com
Sunitha Vemulapalli
- Recruiting
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Site Public Contact, 573-334-2230, sfmc@sfmc.net
Bryan A. Faller
- Recruiting
Mercy Cancer Center - Carmichael
Carmichael, California, 95608
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Mercy San Juan Medical Center
Carmichael, California, 95608
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@commonspirit.org
Shahzad Siddique
- Recruiting
SIH Cancer Institute
Carterville, Illinois, 62918
Site Public Contact, 618-985-3333, clinical.research@sih.net
Bryan A. Faller
- Recruiting
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Mercy Hospital
Cedar Rapids, Iowa, 52403
Site Public Contact, 319-365-4673
Deborah W. Wilbur
- Recruiting
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
Site Public Contact, 319-363-2690
Deborah W. Wilbur
- Recruiting
Miami Valley Hospital South
Centerville, Ohio, 45459
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Centralia Oncology Clinic
Centralia, Illinois, 62801
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Vandalia Health/CAMC Institute for Academic Medicine
Charleston, West Virginia, 25304
Site Public Contact, 304-388-9944, CAMCClinicalTrials@vandaliahealth.org
Ahmed A. Khalid
- Recruiting
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
Site Public Contact, 434-243-6303, uvacancertrials@hscmail.mcc.virginia.edu
Matthew J. Reilley
- Recruiting
Chelsea Hospital
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
Saint Luke's Hospital
Chesterfield, Missouri, 63017
Site Public Contact, 314-205-6936
Meera Rana
- Recruiting
Mount Sinai Hospital Medical Center
Chicago, Illinois, 60608
Site Public Contact, 773-257-5960, suhi@sinai.org
Pam G. Khosla
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Site Public Contact, 312-695-1301, cancer@northwestern.edu
Devalingam Mahalingam
- Recruiting
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612
Site Public Contact, 312-864-5204
Deimante M. Tamkus
- Recruiting
University of Illinois
Chicago, Illinois, 60612
Site Public Contact, 312-355-3046
Ryan Nguyen
- Recruiting
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Ardaman Shergill
- Recruiting
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
Site Public Contact, 773-296-5360
Antony Ruggeri
- Recruiting
Adena Regional Medical Center
Chillicothe, Ohio, 45601
Site Public Contact, 877-779-7585, Jeffh@columbusccop.org
Aruna C. Gowda
- Recruiting
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Active, not recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
- Recruiting
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Nusayba Bagegni
- Recruiting
Case Western Reserve University
Cleveland, Ohio, 44106
Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org
Alberto J. Montero
- Active, not recruiting
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111
- Active, not recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
- Recruiting
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, 28328
Site Public Contact, 919-587-9084, jfields@cancersmoc.com
Samer S. Kasbari
- Recruiting
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, 38017
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Andrew J. Benefield
- Recruiting
Prisma Health Richland Hospital
Columbia, South Carolina, 29203
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Recruiting
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, 39705
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Andrew J. Benefield
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Site Public Contact, 800-293-5066, Jamesline@osumc.edu
Floor Backes
- Recruiting
Mount Carmel East Hospital
Columbus, Ohio, 43213
Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Aruna C. Gowda
- Recruiting
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, 43214
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Aine E. Clements
- Recruiting
Riverside Methodist Hospital
Columbus, Ohio, 43214
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Aine E. Clements
- Recruiting
Grant Medical Center
Columbus, Ohio, 43215
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Aine E. Clements
- Recruiting
The Mark H Zangmeister Center
Columbus, Ohio, 43219
Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Aruna C. Gowda
- Recruiting
Doctors Hospital
Columbus, Ohio, 43228
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Aine E. Clements
- Recruiting
Memorial Sloan Kettering Commack
Commack, New York, 11725
Site Public Contact, 212-639-7592
Alison M. Schram
- Recruiting
Mercy Hospital
Coon Rapids, Minnesota, 55433
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, 33146
Site Public Contact, 305-243-2647
Chukwuemeka (Emeka) V. Ikpeazu
- Recruiting
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Nusayba Bagegni
- Recruiting
UChicago Medicine Northwest Indiana
Crown Point, Indiana, 46307
Site Public Contact, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Ardaman Shergill
- Recruiting
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, 60014
Site Public Contact, 630-929-6129, advocateresearch@advocate.com
Antony Ruggeri
- Recruiting
UPMC Western Maryland
Cumberland, Maryland, 21502
Site Public Contact, 240-964-1400
Adam M. Brufsky
- Recruiting
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu
Devin E. Jones
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
Site Public Contact, 800-446-5532, Research@Carle.com
Tanmay Sahai
- Recruiting
Miami Valley Hospital
Dayton, Ohio, 45409
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Premier Blood and Cancer Center
Dayton, Ohio, 45409
Site Public Contact, 937-276-8320
Tarek M. Sabagh
- Suspended
Dayton Physician LLC - Englewood
Dayton, Ohio, 45415
- Recruiting
Miami Valley Hospital North
Dayton, Ohio, 45415
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Corewell Health Dearborn Hospital
Dearborn, Michigan, 48124
Site Public Contact, 248-551-7695
Dana Zakalik
- Recruiting
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Decatur Memorial Hospital
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442
Site Public Contact, 305-243-2647
Chukwuemeka (Emeka) V. Ikpeazu
- Recruiting
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Devalingam Mahalingam
- Recruiting
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Aine E. Clements
- Recruiting
Grady Memorial Hospital
Delaware, Ohio, 43015
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Aine E. Clements
- Recruiting
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
Site Public Contact, 515-241-3305
Richard L. Deming
- Recruiting
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
Site Public Contact, 815-285-7800
Bryan A. Faller
- Recruiting
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
Site Public Contact, 630-275-1270, Barbara.barhamand@advocatehealth.com
Antony Ruggeri
- Active, not recruiting
Epic Care-Dublin
Dublin, California, 94568
- Recruiting
Columbus Oncology and Hematology Associates
Dublin, Ohio, 43016
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Aine E. Clements
- Recruiting
Dublin Methodist Hospital
Dublin, Ohio, 43016
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Aine E. Clements
- Recruiting
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Site Public Contact, 888-275-3853
Angeles A. Secord
- Recruiting
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Recruiting
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Tareq Al baghdadi
- Recruiting
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Adedayo A. Onitilo
- Recruiting
Fairview Southdale Hospital
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Minnesota Oncology - Edina
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org
Alison K. Conlin
- Recruiting
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Site Public Contact, 800-446-5532, Research@carle.com
Tanmay Sahai
- Recruiting
Crossroads Cancer Center
Effingham, Illinois, 62401
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Advocate Sherman Hospital
Elgin, Illinois, 60123
Site Public Contact, 847-429-2907
Antony Ruggeri
- Recruiting
Mercy Cancer Center - Elk Grove
Elk Grove, California, 95758
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
UC San Diego Health System - Encinitas
Encinitas, California, 92024
Site Public Contact, 760-536-7700
Peter Vu
- Recruiting
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, 16505
Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu
Adam M. Brufsky
- Recruiting
OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan, 49829
Site Public Contact, 920-433-8889, WI_research_admin@hshs.org
Brian L. Burnette
- Recruiting
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201
Site Public Contact, 847-570-2109
Mary T. Jenkins Vogel
- Recruiting
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Site Public Contact, 703-720-5210, Stephanie.VanBebber@inova.org
Timothy L. Cannon
- Recruiting
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Site Public Contact, 703-208-6650, Stephanie.VanBebber@inova.org
Timothy L. Cannon
- Recruiting
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
Site Public Contact, 701-234-6161, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Parkland Health Center - Farmington
Farmington, Missouri, 63640
Site Public Contact, 314-996-5569
Bryan A. Faller
- Suspended
Corewell Health Farmington Hills Hospital
Farmington Hills, Michigan, 48336
- Suspended
Armes Family Cancer Center
Findlay, Ohio, 45840
- Recruiting
Hunterdon Medical Center
Flemington, New Jersey, 08822
Site Public Contact, 908-237-2330
Myron E. Bednar
- Recruiting
Cancer Hematology Centers - Flint
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Tareq Al baghdadi
- Suspended
Genesee Hematology Oncology PC
Flint, Michigan, 48503
- Recruiting
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Tareq Al baghdadi
- Recruiting
Hurley Medical Center
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Tareq Al baghdadi
- Recruiting
Poudre Valley Hospital
Fort Collins, Colorado, 80524
Site Public Contact, 970-297-6150
Bradley R. Corr
- Recruiting
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, 80528
Site Public Contact, ecog.rss@jimmy.harvard.edu
Bradley R. Corr
- Active, not recruiting
Broward Health Medical Center
Fort Lauderdale, Florida, 33316
- Recruiting
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Suspended
Dayton Physicians LLC-Atrium
Franklin, Ohio, 45005
- Recruiting
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
Site Public Contact, 208-381-2774, eslinget@slhs.org
Alison K. Conlin
- Recruiting
UF Health Cancer Institute - Gainesville
Gainesville, Florida, 32610
Site Public Contact, 352-273-8010, cancer-center@ufl.edu
Thomas J. George
- Recruiting
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Devalingam Mahalingam
- Recruiting
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022
Site Public Contact, 414-302-2304, ncorp@aurora.org
Antony Ruggeri
- Recruiting
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, 60026
Site Public Contact, 847-570-2109
Mary T. Jenkins Vogel
- Recruiting
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, 60026
Site Public Contact, 312-695-1102
Devalingam Mahalingam
- Recruiting
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, 27534
Site Public Contact, 919-587-9084, jfields@cancersmoc.com
Samer S. Kasbari
- Recruiting
CTCA at Western Regional Medical Center
Goodyear, Arizona, 85338
Site Public Contact, 623-207-3000
Sagun Shrestha
- Recruiting
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024
Site Public Contact, 414-302-2304, ncorp@aurora.org
Antony Ruggeri
- Recruiting
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Tareq Al baghdadi
- Recruiting
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, 60030
Site Public Contact, 312-695-1102
Devalingam Mahalingam
- Recruiting
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
UCHealth Greeley Hospital
Greeley, Colorado, 80631
Site Public Contact, ecog.rss@jimmy.harvard.edu
Bradley R. Corr
- Recruiting
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
Site Public Contact, 920-433-8889, WI_research_admin@hshs.org
Brian L. Burnette
- Recruiting
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
Site Public Contact, 920-433-8889, wi_research_admin@hshs.org
Brian L. Burnette
- Recruiting
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311
Site Public Contact, 414-302-2304, ncorp@aurora.org
Antony Ruggeri
- Recruiting
Cone Health Cancer Center
Greensboro, North Carolina, 27403
Site Public Contact, 336-832-0836, stacey.phelps@conehealth.com
Vinay K. Gudena
- Recruiting
Cone Health Cancer Center at Drawbridge Parkway
Greensboro, North Carolina, 27410
Site Public Contact, 336-832-0836, stacey.phelps@conehealth.com
Vinay K. Gudena
- Recruiting
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, 15601
Site Public Contact, 724-838-1900
Adam M. Brufsky
- Recruiting
Miami Valley Cancer Care and Infusion
Greenville, Ohio, 45331
Site Public Contact, 937-569-7515
Tarek M. Sabagh
- Recruiting
Saint Francis Hospital
Greenville, South Carolina, 29601
Site Public Contact, 864-603-6234, Heather_Rich@bshsi.org
Stephen H. Dyar
- Recruiting
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, 29605
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Recruiting
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Recruiting
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Recruiting
Saint Francis Cancer Center
Greenville, South Carolina, 29607
Site Public Contact, 864-603-6234, Heather_Rich@bshsi.org
Stephen H. Dyar
- Recruiting
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Recruiting
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Recruiting
Baptist Cancer Center-Grenada
Grenada, Mississippi, 38901
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Andrew J. Benefield
- Suspended
Zangmeister Center Grove City
Grove City, Ohio, 43123
- Active, not recruiting
Gulfport Memorial Hospital
Gulfport, Mississippi, 39502
- Recruiting
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Site Public Contact, 212-639-7592
Alison M. Schram
- Recruiting
Ingalls Memorial Hospital
Harvey, Illinois, 60426
Site Public Contact, 708-915-4673, clinicaltrials@ingalls.org
James A. Wallace
- Recruiting
Advocate South Suburban Hospital
Hazel Crest, Illinois, 60429
Site Public Contact, 708-799-9995
Antony Ruggeri
- Recruiting
Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania, 18201
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Tareq Al baghdadi
- Recruiting
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
Site Public Contact, 218-786-3308
Bret E. Friday
- Recruiting
Hayworth Cancer Center
High Point, North Carolina, 27262
Site Public Contact, 336-802-2500
Anna Kuan-Celarier
- Recruiting
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, 60035
Site Public Contact, 847-570-2109
Mary T. Jenkins Vogel
- Recruiting
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813
Site Public Contact, 808-524-6115, i.webster@hawaiicancercare.com
Jeffrey L. Berenberg
- Recruiting
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii, 96813
Site Public Contact, 808-532-0315
Jeffrey L. Berenberg
- Recruiting
Queen's Medical Center
Honolulu, Hawaii, 96813
Site Public Contact, 808-545-8548
Jeffrey L. Berenberg
- Recruiting
Straub Clinic and Hospital
Honolulu, Hawaii, 96813
Site Public Contact, 808-522-4333
Jeffrey L. Berenberg
- Recruiting
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
Site Public Contact, 808-586-2979
Jeffrey L. Berenberg
- Recruiting
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, 96817
Site Public Contact, 808-531-8521
Jeffrey L. Berenberg
- Recruiting
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
Site Public Contact, 808-983-6090
Jeffrey L. Berenberg
- Recruiting
Lyndon Baines Johnson General Hospital
Houston, Texas, 77026-1967
Site Public Contact, 713-566-5000
Funda Meric-Bernstam
- Active, not recruiting
Houston Methodist Hospital
Houston, Texas, 77030
- Recruiting
UT MD Anderson Cancer Center
Houston, Texas, 77030
Site Public Contact, 866-632-6789, askmdanderson@mdanderson.org
Funda Meric-Bernstam
- Active, not recruiting
Methodist Willowbrook Hospital
Houston, Texas, 77070
- Active, not recruiting
Houston Methodist West Hospital
Houston, Texas, 77094
- Recruiting
Edwards Comprehensive Cancer Center
Huntington, West Virginia, 25701
Site Public Contact, 304-399-6566, Christina.Cole@chhi.org
Toni O. Pacioles
- Recruiting
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org
Alison K. Conlin
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Site Public Contact, 855-776-0015
Aaron S. Mansfield
- Recruiting
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, 28546
Site Public Contact, 910-587-9084, jfields@cancersmoc.com
Samer S. Kasbari
- Recruiting
Mercyhealth Hospital and Cancer Center - Janesville
Janesville, Wisconsin, 53548
Site Public Contact, 608-756-6871, oncologyclinicaltrials@mhemail.org
Emily G. Robinson
- Recruiting
Regional Cancer Center at Johnson City Medical Center
Johnson City, Tennessee, 37604
Site Public Contact, 423-431-5654, charles.mays@balladhealth.org
Asheesh Shipstone
- Recruiting
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, 72401
Site Public Contact, 870-936-7066, Emily.Carvell@bmhcc.org
Andrew J. Benefield
- Recruiting
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Suspended
Beacon Kalamazoo Cancer Center
Kalamazoo, Michigan, 49009
- Suspended
Beacon Kalamazoo
Kalamazoo, Michigan, 49048
- Recruiting
Logan Health Medical Center
Kalispell, Montana, 59901
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142
Site Public Contact, 414-302-2304, ncorp@aurora.org
Antony Ruggeri
- Suspended
Greater Dayton Cancer Center
Kettering, Ohio, 45409
- Recruiting
Kettering Medical Center
Kettering, Ohio, 45429
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Kingman Regional Medical Center
Kingman, Arizona, 86401
Site Public Contact, 702-384-0013, research@sncrf.org
Khawaja S. Jahangir
- Recruiting
Ballad Health Cancer Care - Kingsport
Kingsport, Tennessee, 37660
Site Public Contact, 423-431-5654, charles.mays@balladhealth.org
Asheesh Shipstone
- Recruiting
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
Site Public Contact, 608-775-2385, cancerctr@gundersenhealth.org
Kurt Oettel
- Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Site Public Contact, 858-822-5354, cancercto@ucsd.edu
Peter Vu
- Recruiting
Providence Regional Cancer System-Lacey
Lacey, Washington, 98503
Site Public Contact, 360-412-8958, deidre.dillon@providence.org
Alison K. Conlin
- Recruiting
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045
Site Public Contact, cancertrials@northwestern.edu
Devalingam Mahalingam
- Recruiting
Monmouth Medical Center Southern Campus
Lakewood, New Jersey, 08701
Site Public Contact, 732-923-6564, mary.danish@rwjbh.org
Patrick M. Boland
- Recruiting
Fairfield Medical Center
Lancaster, Ohio, 43130
Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Aruna C. Gowda
- Recruiting
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912
Site Public Contact, 517-364-3712, harsha.trivedi@umhsparrow.org
Tareq Al baghdadi
- Recruiting
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, 89102
Site Public Contact, 702-384-0013, research@sncrf.org
Khawaja S. Jahangir
- Recruiting
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135
Site Public Contact, 702-384-0013, research@sncrf.org
Khawaja S. Jahangir
- Recruiting
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144
Site Public Contact, 702-384-0013, research@sncrf.org
Khawaja S. Jahangir
- Suspended
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89183
- Recruiting
CommonSpirit Saint Joseph Medical Center - East Lexington
Lexington, Kentucky, 40509
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
Site Public Contact, 859-257-3379
Susanne M. Arnold
- Recruiting
AMG Libertyville - Oncology
Libertyville, Illinois, 60048
Site Public Contact, 630-929-6129, advocateresearch@advocatehealth.com
Antony Ruggeri
- Recruiting
Condell Memorial Hospital
Libertyville, Illinois, 60048
Site Public Contact, 630-929-6129, advocateresearch@advocatehealth.com
Antony Ruggeri
- Recruiting
Cooperman Barnabas Medical Center
Livingston, New Jersey, 07039
Site Public Contact, 973-322-5200
Patrick M. Boland
- Recruiting
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
Monmouth Medical Center
Long Branch, New Jersey, 07740
Site Public Contact, 732-923-6564, mary.danish@rwjbh.org
Patrick M. Boland
- Recruiting
The Angeles Clinic and Research Institute - West Los Angeles Office
Los Angeles, California, 90025
Site Public Contact, ecog.rss@jimmy.harvard.edu
Omid Hamid
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Site Public Contact, 310-423-2133, Cancer.trial.info@cshs.org
Omid Hamid
- Recruiting
Medical Center of the Rockies
Loveland, Colorado, 80538
Site Public Contact, 970-203-7083
Bradley R. Corr
- Active, not recruiting
Covenant Medical Center-Lakeside
Lubbock, Texas, 79410
- Recruiting
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Henry Ford Saint John Hospital - Macomb Medical
Macomb, Michigan, 48044
Site Public Contact, 313-343-3166, kforman1@hfhs.org
Tareq Al baghdadi
- Recruiting
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, 53718
Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu
Nataliya V. Uboha
- Recruiting
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu
Nataliya V. Uboha
- Recruiting
Schoolcraft Memorial Hospital
Manistique, Michigan, 49854
Site Public Contact, 920-433-8889, WI_research_admin@hshs.org
Brian L. Burnette
- Recruiting
OhioHealth Mansfield Hospital
Mansfield, Ohio, 44903
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Aine E. Clements
- Recruiting
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143
Site Public Contact, 414-302-2304, ncorp@aurora.org
Antony Ruggeri
- Recruiting
OhioHealth Marion General Hospital
Marion, Ohio, 43302
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Aine E. Clements
- Recruiting
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Adedayo A. Onitilo
- Active, not recruiting
Contra Costa Regional Medical Center
Martinez, California, 94553-3156
- Recruiting
Memorial Hospital
Marysville, Ohio, 43040
Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Aruna C. Gowda
- Recruiting
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Site Public Contact, 800-446-5532, Research@carle.com
Tanmay Sahai
- Active, not recruiting
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, 44124
- Recruiting
Loyola University Medical Center
Maywood, Illinois, 60153
Site Public Contact, 708-226-4357
Nan Sethakorn
- Recruiting
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania, 17050
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Adam M. Brufsky
- Recruiting
Riddle Memorial Hospital
Media, Pennsylvania, 19063
Site Public Contact, 484-476-2649, turzoe@mlhs.org
Paul B. Gilman
- Recruiting
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Andrew J. Benefield
- Recruiting
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, 44060
Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org
Alberto J. Montero
- Recruiting
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642
Site Public Contact, 208-381-2774, eslinget@slhs.org
Alison K. Conlin
- Active, not recruiting
East Jefferson General Hospital
Metairie, Louisiana, 70006
- Recruiting
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
Site Public Contact, 305-243-2647
Chukwuemeka (Emeka) V. Ikpeazu
- Recruiting
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, 33176
Site Public Contact, 305-243-2647
Chukwuemeka (Emeka) V. Ikpeazu
- Recruiting
Woodland Cancer Care Center
Michigan City, Indiana, 46360
Site Public Contact, 219-861-5800, Anna.Huron@franciscanalliance.org
William H. Bae
- Active, not recruiting
UH Seidman Cancer Center at Southwest General Hospital
Middleburg Heights, Ohio, 44130
- Recruiting
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Site Public Contact, 212-639-7592
Alison M. Schram
- Recruiting
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, 53209
Site Public Contact, 414-302-2304, ncorp@aurora.org
Antony Ruggeri
- Recruiting
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
Site Public Contact, 414-302-2304, ncorp@aurora.org
Antony Ruggeri
- Recruiting
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233
Site Public Contact, 414-302-2304, ncorp@aurora.org
Antony Ruggeri
- Recruiting
NYU Langone Hospital - Long Island
Mineola, New York, 11501
Site Public Contact, 212-263-4432, cancertrials@nyulangone.org
Kristen R. Spencer
- Recruiting
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Adedayo A. Onitilo
- Recruiting
Community Medical Center
Missoula, Montana, 59804
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, 36688
Site Public Contact, 251-445-9870, pfrancisco@usouthal.edu
Ahmed Abdalla
- Recruiting
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania, 15146
Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu
Adam M. Brufsky
- Recruiting
West Virginia University Healthcare
Morgantown, West Virginia, 26506
Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu
Mohammed Almubarak
- Recruiting
SSM Health Good Samaritan
Mount Vernon, Illinois, 62864
Site Public Contact, 618-899-1894, gayla.hall@ssmhealth.com
Jay W. Carlson
- Recruiting
Knox Community Hospital
Mount Vernon, Ohio, 43050
Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Aruna C. Gowda
- Recruiting
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149
Site Public Contact, research.institute@phci.org
Timothy R. Wassenaar
- Recruiting
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Tareq Al baghdadi
- Recruiting
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
Tareq Al baghdadi
- Recruiting
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83687
Site Public Contact, 208-381-2774, eslinget@slhs.org
Alison K. Conlin
- Recruiting
Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee, 37204
Site Public Contact, 800-811-8480
Jennifer H. Choe
- Recruiting
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Site Public Contact, 800-811-8480
Jennifer H. Choe
- Active, not recruiting
Houston Methodist Saint John Hospital
Nassau Bay, Texas, 77058
- Recruiting
ThedaCare Regional Medical Center - Neenah
Neenah, Wisconsin, 54956
Site Public Contact, 920-364-3605, ResearchDept@thedacare.org
Matthias Weiss
- Recruiting
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi, 38652
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Andrew J. Benefield
- Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Site Public Contact, 732-235-7356
Patrick M. Boland
Puerto Rico4 sites, 4 recruiting
- Recruiting
Puerto Rico Hematology Oncology Group
Bayamón, 00961
Site Public Contact, 787-780-2865
Luis J. Santos Reyes
- Recruiting
Doctors Cancer Center
Manati, 00674
Site Public Contact, 787-621-4397
Luis J. Santos Reyes
- Recruiting
Centro Comprensivo de Cancer de UPR
San Juan, 00927
Site Public Contact, ecog.rss@jimmy.harvard.edu
Luis J. Santos Reyes
- Recruiting
PROncology
San Juan, 00927
Site Public Contact, 787-919-7919, info@PRoncology.com
Luis J. Santos Reyes
About this study
Official title: Molecular Analysis for Combination Therapy Choice (ComboMATCH)
This ComboMATCH patient screening trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. Patients with solid tumors that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment that has been shown to prolong overall survival may be candidates for these trials. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with some genetic changes or abnormalities (mutations) may benefit from treatment that targets that particular genetic mutation. ComboMATCH is designed to match patients to a treatment that may work to control their tumor and may help doctors plan better treatment for patients with locally advanced or advanced solid tumors.
Read the detailed description
PRIMARY OBJECTIVE:
- To register, allocate, and assign patients to ComboMATCH treatment trials.
SECONDARY OBJECTIVES:
- To evaluate the rate of positive outcomes in defined cohorts within treatment trials of treatment combinations including targeted therapies for molecularly defined populations, and also in the subset of treatment trials where the treatments are supported by in vivo models.
II. To perform quality control of the patients registered in the form of pathological confirmation of disease and sub-type to confirm diagnosis and treatment arm allocation.
SECONDARY CORRELATIVE OBJECTIVES:
- Assess the concordance of the central molecular characterization of the pre-treatment biopsy samples with the genetic readouts from the Designated Laboratories (DLs) for patients enrolled on the ComboMATCH treatment trials.
II. To assess how the registration diagnostic tumor mutation profile and pre-treatment biopsy profile compare to the circulating tumor-derived deoxyribonucleic acid (ctDNA) mutation profile from plasma.
EXPLORATORY OBJECTIVE:
- Assess association between ComboMATCH treatment trials outcomes (positive or negative) with the type of rationale for the selected drug combinations and the type of rationale for the gene variant/combination for selection (e.g., whether the trial was based on targeted therapies for molecularly defined populations, those that were supported by in vivo models, and those that were supported by empiric clinical data).
OUTLINE:
REGISTRATION: Patients undergo tumor mutational screening of previously-collected tumor samples for specific, pre-defined mutations, amplifications, or translocations of interest via tumor sequencing. Patients who are 18 years or older and have biopsiable disease undergo a new biopsy for research purposes prior to initiating treatment on the ComboMATCH treatment trial.
TREATMENT: Patients with mutations targeted to investigational combination therapies are assigned to 1 of 20 treatment subprotocols.
EAY191-N4: Patients with RAS pathway mutant ovarian or endometrial cancer are randomized to 1 of 2 arms.
ARM I: Patients receive selumetinib orally (PO) twice daily (BID) and olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo a tumor biopsy and blood collection during screening and on study, as well as echocardiogram (ECHO) or multigated acquisition (MUGA), and computed tomography (CT) scans throughout the trial. Patients may undergo bone marrow aspiration or biopsy as clinically indicated.
ARM II: Patients receive selumetinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience progression may elect to cross over to Arm I provided they have not had dose limiting toxicities to monotherapy selumetinib. Patients also undergo a tumor biopsy and blood collection during screening and on study, as well as ECHO or MUGA, and CT scans throughout the trial. Patients may undergo bone marrow aspiration or biopsy as clinically indicated.
EAY191-N2: Patients with inactivating or inferred inactivating NF1 alterations, and hormone receptor positive, HER2-negative metastatic breast cancer. Patients who are fulvestrant naive are assigned to Cohort I, while patients who are fulvestrant resistant are assigned to Cohort II.
COHORT I: Patients are randomized to 1 of 2 arms.
ARM I:Patients receive fulvestrant intramuscularly (IM) on day 1 and day 15 of cycle 1 and day 1 of subsequent cycles and binimetinib PO BID on days 15 to 28 of cycle 1 and day 1 through 28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT, magnetic resonance imaging (MRI), or bone scan, ECHO or MUGA, and tumor biopsy, as well as possible blood sample collection during screening and on study.
ARM II: Patients receive fulvestrant IM on day 1 and day 15 of cycle 1 and day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who progress on fulvestrant alone may migrate to cohort II if they meet the migration eligibility criteria. Patients not willing to migrate to cohort II will have further therapy at the investigator's discretion. Patients undergo a CT, MRI, or bone scan and tumor biopsy, as well as ECHO or MUGA and possible blood sample collection during screening and on study.
COHORT II: Patients receive fulvestrant IM on day 1 of each cycle and binimetinib PO BID on days 15-28 of cycle 1 and day 1 through 28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT, MRI, or bone scan, ECHO or MUGA and tumor biopsy, as well as possible blood sample collection during screening and on study.
EAY191-E4: Patients with solid tumors who previously underwent taxane therapy.
Patients receive nilotinib hydrochloride monohydrate PO BID on days 1-28 and paclitaxel intravenously (IV) over 1 hour on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI during screening or cycle 1 day 1, every 2 cycles for 1 year, every 3 cycles for patients on study for more than 1 year, and every 4 cycles for patients on study for more than 3 years and may also undergo CT or MRI during follow-up every 3 months for 2 years and then every 6 months for 1 year if clinically indicated. Patients also undergo collection of blood samples at baseline, cycle 2 day 1, and optionally at progression as well as tumor biopsy at baseline and optionally at progression.
EAY191-A3: Patients with KRAS/NRAS/BRAF mutated low-grade serous ovarian cancer (LGSOC) naive to MEK or CDK4/6 inhibitor therapy are randomized to either combination cohort 1 or monotherapy cohort 1. Patients with LGSOC who have received prior MEK inhibitor therapy are assigned to combination cohort 2. Patients with KRAS/NRAS/HRAS/non-V600E BRAF mutated pancreatic cancer are assigned to combination cohort 3. Patients with all other KRAS/NRAS/HRAS mutated tumor types (excluding LGSOC, non-small cell lung cancer, colorectal cancer, pancreatic, and melanoma) are assigned to combination cohort 4.
COMBINATION COHORTS 1, 2, 3, 4: Patients receive palbociclib PO and binimetinib PO throughout the trial. Patients may also undergo biopsy at screening and undergo MRI, CT, bone scan, and collection of blood samples during screening, on study, and/or during follow up.
MONOTHERAPY COHORT 1: Patients receive binimetinib PO throughout the trial. Patients may also undergo biopsy at screening and undergo MRI, CT, bone scan, and collection of blood samples during screening, on study, and/or during follow up.
EAY191-S3: Patients with an activating AKT mutation solid tumor.
Patients receive paclitaxel IV on days 1, 8, and 15 and ipatasertib PO on days 1-21 of each cycle. Treatment repeats every 28 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or MRI and blood collection throughout the trial. Patients also undergo a tumor biopsy during screening and optionally during follow-up.
EAY191-A6: Patients with RAS/RAF/MEK/ERK mutant biliary tract cancers are randomized to 1 of 2 arms.
ARM 1: Patients receive leucovorin IV, oxaliplatin IV, and fluorouracil IV on study. Patients undergo echocardiogram (ECHO) and multigated acquisition scan (MUGA) during screening and on study, a CT with contrast, MRI, or a fludeoxyglucose F-18 positron emission tomography (FDG-PET) during screening, collection of blood during screening and on study, and a biopsy during screening. Patients may also undergo brain MRI or CT during screening and on study, bone scans on study, and biopsy on study if clinically indicated.
ARM 2: Patients receive binimetinib PO, leucovorin IV, oxaliplatin IV, and fluorouracil IV on study. Patients undergo ECHO and MUGA during screening and on study, a CT with contrast, MRI, or an FDG-PET during screening, collection of blood during screening and on study, and a biopsy during screening. Patients may also undergo brain MRI or CT during screening and on study, bone scans on study, and biopsy on study if clinically indicated.
EAY191-E5: Patients are assigned to 1 of 2 cohorts.
COHORT I: Patients who have never received a KRAS G12C inhibitor are randomized to arms A or B.
ARM A: Patients receive sotorasib PO once daily (QD) on days 1-28 and panitumumab intravenously IV on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples, biopsy, and CT or MRI on study.
ARM B: Patients receive sotorasib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross-over to cohort II. Patients also undergo collection of blood samples, biopsy, and CT or MRI on study.
COHORT II: Patients who have received a KRAS G12C inhibitor are assigned to arm C.
ARM C: Patients receive combination therapy as in Arm A.
EAY191-A2: Patients are assigned to 1 of 3 cohorts.
COHORT 1: PARP-inhibitor naive patients are assigned to Arm A.
ARM A: Patients receive olaparib PO BID and alpelisib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression.
COHORT 2: PARP-inhibitor naive patients are randomized to 1 of 2 arms.
ARM B: Patients receive olaparib PO BID and alpelisib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression.
ARM C: Patients receive olaparib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients experiencing disease progression have the option to migrate to Cohort 3, Arm D. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression.
COHORT 3: PARP-inhibitor resistant patients are assigned to Arm D.
ARM D: Patients receive olaparib PO BID and alpelisib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression.
EAY191-N5: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive neratinib maleate PO QD on days 1-14 of cycle 0 in the absence of disease progression or unacceptable toxicity. Patients then receive neratinib maleate PO QD on days 1-28 of each subsequent cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience progression may crossover to Arm II. Patients undergo ECHO or MUGA during screening and on study, and CT or MRI and collection of blood samples throughout the trial. Patients may also undergo tumor biopsy during screening and on study.
ARM II: Patients receive neratinib maleate PO QD on days 1-14 of cycle 0 in the absence of disease progression or unacceptable toxicity. Patients then receive neratinib maleate PO QD on days 1-28 and palbociclib PO QD on days 1-21 of each subsequent cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening and on study, and CT or MRI and collection of blood samples throughout the trial. Patients may also undergo tumor biopsy during screening and on study.
- Conditions
- Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Locally Advanced Malignant Solid Neoplasm, Malignant Female Reproductive System Neoplasm, Metastatic HER2-Negative Breast Carcinoma
- Being tested
- Alpelisib, Binimetinib, Biopsy Procedure, Biospecimen Collection, Bone Marrow Aspiration
- Medical subject headings
- Neoplasm Metastasis, Endometrial Neoplasms, Fallopian Tube Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlpelisibDrug
Also called BYL 719, BYL-719, BYL719, Phosphoinositide 3-kinase Inhibitor BYL719
Given PO
BinimetinibDrug
Also called ARRY 162, ARRY 438162, ARRY-162, ARRY-438162
Given PO
Biopsy ProcedureProcedure or surgery
Also called Biopsy, BIOPSY_TYPE, Bx
Undergo biopsy
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo blood collection
Bone Marrow AspirationProcedure or surgery
Undergo bone marrow aspiration
Bone Marrow BiopsyProcedure or surgery
Also called Biopsy of Bone Marrow, Biopsy, Bone Marrow
Undergo bone marrow biopsy
Bone ScanProcedure or surgery
Also called Bone Scintigraphy
Undergo bone scan
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
Echocardiography TestProcedure or surgery
Also called EC, Echocardiography
Undergo ECHO
FluorouracilDrug
Also called 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
Given IV
FulvestrantDrug
Also called Faslodex, Faslodex(ICI 182,780), ICI 182,780, ICI 182780
Given IM
IpatasertibDrug
Also called GDC 0068, GDC-0068, GDC0068, RG 7440
Given PO
LeucovorinDrug
Also called Folinic acid
Given IV
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
Multigated Acquisition ScanProcedure or surgery
Also called Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan
Undergo MUGA
Mutation Carrier ScreeningProcedure or surgery
Undergo tumor mutational screening
Neratinib MaleateDrug
Also called 2-Butenamide, N-(4-((3-chloro-4-(2-pyridinylmethoxy)phenyl)amino)-3-cyano-7-ethoxy-6-quinolinyl)-4-(dimethylamino)-, (2E)-, (2Z)-2-butenedioate (1:1), HKI-272 Maleate, NERATINIB MALEATE ANHYDROUS, Nerlynx
Given PO
Nilotinib Hydrochloride MonohydrateDrug
Also called AMN 107, AMN-107, AMN107, Nilotinib Monohydrochloride Monohydrate
Given PO
OlaparibDrug
Also called AZD 2281, AZD-2281, AZD2281, KU 0059436
Given PO
OxaliplatinDrug
Also called 1-OHP, Ai Heng, Aiheng, Dacotin
Given IV
PaclitaxelDrug
Also called Anzatax, Asotax, Bristaxol, Praxel
Given PO or IV
PalbociclibDrug
Also called 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one, Ibrance, PD 0332991, PD 332991
Given PO
PanitumumabBiological
Also called ABX-EGF, ABX-EGF Monoclonal Antibody, ABX-EGF, Clone E7.6.3, E7.6.3
Given IV
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET
Selumetinib SulfateDrug
Also called AZD-6244 Hydrogen Sulfate, AZD6244 Hydrogen Sulfate, AZD6244 Hydrogen Sulphate, Koselugo
Given PO
SotorasibDrug
Also called AMG 510, AMG-510, AMG510, Lumakras
Given PO
| Study group | Role | What they receive |
|---|---|---|
| EAY191-A2 (Cohort 1, Arm A) | Experimental | Cohort 1, Arm A: Patients receive olaparib PO BID and alpelisib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression. Receives: Drug: Alpelisib; Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Drug: Olaparib; Procedure: Positron Emission Tomography |
| EAY191-A2 (Cohort 2, Arm B) | Experimental | Cohort 2, Arm B: Patients receive olaparib PO BID and alpelisib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression. Receives: Drug: Alpelisib; Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Drug: Olaparib; Procedure: Positron Emission Tomography |
| EAY191-A2 (Cohort 2, Arm C) | Experimental | Cohort 2, Arm C: Patients receive olaparib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients experiencing disease progression have the option to migrate to Cohort 3, Arm D. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Drug: Olaparib; Procedure: Positron Emission Tomography |
| EAY191-A2 (Cohort 3, Arm D) | Experimental | Cohort 3, Arm D: Patients receive olaparib PO BID and alpelisib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression. Receives: Drug: Alpelisib; Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Computed Tomography; Drug: Olaparib; Procedure: Positron Emission Tomography |
| EAY191-A3 Combo Cohorts 1, 2, 3, 4 (palbociclib, binimetinib) | Experimental | Patients receive palbociclib PO and binimetinib PO throughout the trial. Patients may also undergo biopsy at screening and undergo MRI, CT, bone scan, and collection of blood samples during screening, on study, and/or during follow up. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Drug: Palbociclib |
| EAY191-A3 Monotherapy Cohort 1 (binimetinib) | Experimental | Patients receive binimetinib PO throughout the trial. Patients may also undergo biopsy at screening and undergo MRI, CT, bone scan, and collection of blood samples during screening, on study, and/or during follow up. Receives: Drug: Binimetinib; Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging |
| EAY191-A6 Arm I (RAS/RAF/MEK/ERK mutations) | Experimental | Patients receive leucovorin IV, oxaliplatin IV, and fluorouracil IV on study. Patients undergo ECHO and MUGA during screening and on study, a CT with contrast, MRI, or a FDG-PET during screening, collection of blood during screening and on study, and a biopsy during screening. Patients may also undergo brain MRI or CT during screening and on study, bone scans on study, and biopsy on study if clinically indicated. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Computed Tomography; Procedure: Echocardiography Test; Drug: Fluorouracil; Drug: Leucovorin; Procedure: Magnetic Resonance Imaging; Procedure: Multigated Acquisition Scan; Drug: Oxaliplatin; Procedure: Positron Emission Tomography |
| EAY191-A6 Arm II (RAS/RAF/MEK/ERK mutations) | Experimental | Patients receive binimetinib PO, leucovorin IV, oxaliplatin IV, and fluorouracil IV on study. Patients undergo ECHO and MUGA during screening and on study, a CT with contrast, MRI, or an FDG-PET during screening, collection of blood during screening and on study, and a biopsy during screening. Patients may also undergo brain MRI or CT during screening and on study, bone scans on study, and biopsy on study if clinically indicated Receives: Drug: Binimetinib; Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Computed Tomography; Procedure: Echocardiography Test; Drug: Fluorouracil; Drug: Leucovorin; Procedure: Magnetic Resonance Imaging; Procedure: Multigated Acquisition Scan; Drug: Oxaliplatin; Procedure: Positron Emission Tomography |
| EAY191-E4 (taxane therapy) | Experimental | Patients receive nilotinib hydrochloride monohydrate PO BID on days 1-28 and paclitaxel IV over 1 hour on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI during screening or cycle 1 day 1, every 2 cycles for 1 year, every 3 cycles for patients on study for more than 1 year, and every 4 cycles for patients on study for more than 3 years and may also undergo CT or MRI during follow-up every 3 months for 2 years and then every 6 months for 1 year if clinically indicated. Patients also undergo collection of blood samples at baseline, cycle 2 day 1, and optionally at progression as well as tumor biopsy at baseline and optionally at progression. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Drug: Nilotinib Hydrochloride Monohydrate; Drug: Paclitaxel |
| EAY191-E5 Cohort I Arm A (sotorasib, panitumumab) | Experimental | Patients receive sotorasib PO QD on days 1-28 and panitumumab IV on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples, biopsy, and CT or MRI on study. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Biological: Panitumumab; Drug: Sotorasib |
| EAY191-E5 Cohort I Arm B (sotorasib) | Active comparator | Patients receive sotorasib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross-over to cohort II. Patients also undergo collection of blood samples, biopsy, and CT or MRI on study. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Drug: Sotorasib |
| EAY191-E5 Cohort II (sotorasib) | Experimental | Patients receive combination therapy as in EAY191-E5 Arm A. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Biological: Panitumumab; Drug: Sotorasib |
| EAY191-N2 Cohort I (Arm I) (NF1 mutations) | Experimental | Patients receive fulvestrant IM on day 1 and day 15 of cycle 1 and day 1 of subsequent cycles and binimetinib PO BID on days 15 to 28 of cycle 1 and day 1 through 28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT, MRI, or bone scan, ECHO or MUGA, and tumor biopsy, as well as possible blood sample collection during screening and on study. Receives: Drug: Binimetinib; Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Computed Tomography; Procedure: Echocardiography Test; Drug: Fulvestrant; Procedure: Magnetic Resonance Imaging; Procedure: Multigated Acquisition Scan |
| EAY191-N2 Cohort I (Arm II) (NF1 mutations) | Experimental | Patients receive fulvestrant IM on day 1 and day 15 of cycle 1 and day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who progress on fulvestrant alone may migrate to cohort II if they meet the migration eligibility criteria. Patients not willing to migrate to cohort II will have further therapy at the investigator's discretion. Patients undergo a CT, MRI, or bone scan and tumor biopsy, as well as ECHO or MUGA and possible blood sample collection during screening and on study. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Computed Tomography; Procedure: Echocardiography Test; Drug: Fulvestrant; Procedure: Magnetic Resonance Imaging; Procedure: Multigated Acquisition Scan |
| EAY191-N2 Cohort II (NF1 mutations) | Experimental | Patients receive fulvestrant IM on day 1 of each cycle and binimetinib PO BID on days 15-28 of cycle 1 and day 1 through 28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT, MRI, or bone scan, ECHO or MUGA and tumor biopsy, as well as possible blood sample collection during screening and on study. Receives: Drug: Binimetinib; Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Computed Tomography; Procedure: Echocardiography Test; Drug: Fulvestrant; Procedure: Magnetic Resonance Imaging; Procedure: Multigated Acquisition Scan |
| EAY191-N4 Arm I (RAS pathway mutations) | Experimental | Patients receive selumetinib PO BID and olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo a tumor biopsy and blood collection during screening and on study, as well as ECHO or MUGA, and CT scans throughout the trial. Patients may undergo bone marrow aspiration or biopsy as clinically indicated. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Procedure: Echocardiography Test; Procedure: Multigated Acquisition Scan; Procedure: Mutation Carrier Screening; Drug: Olaparib; Drug: Selumetinib Sulfate |
| EAY191-N4 Arm II (RAS pathway mutations) | Active comparator | Patients receive selumetinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience progression may elect to cross over to Arm I provided they have not had dose limiting toxicities to monotherapy selumetinib. Patients also undergo a tumor biopsy and blood collection during screening and on study, as well as ECHO or MUGA, and CT scans throughout the trial. Patients may undergo bone marrow aspiration or biopsy as clinically indicated. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Procedure: Echocardiography Test; Procedure: Multigated Acquisition Scan; Procedure: Mutation Carrier Screening; Drug: Selumetinib Sulfate |
| EAY191-N5 Arm I (neratinib maleate) | Active comparator | Patients receive neratinib maleate PO QD on days 1-14 of cycle 0 in the absence of disease progression or unacceptable toxicity. Patients then receive neratinib maleate PO QD on days 1-28 of each subsequent cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience progression may crossover to Arm II. Patients undergo ECHO or MUGA during screening and on study, and CT or MRI and collection of blood samples throughout the trial. Patients may also undergo tumor biopsy during screening and on study. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Echocardiography Test; Procedure: Magnetic Resonance Imaging; Procedure: Multigated Acquisition Scan; Drug: Neratinib Maleate |
| EAY191-N5 Arm II (neratinib maleate,palbociclib) | Experimental | Patients receive neratinib maleate PO QD on days 1-14 of cycle 0 in the absence of disease progression or unacceptable toxicity. Patients then receive neratinib maleate PO QD on days 1-28 and palbociclib PO QD on days 1-21 of each subsequent cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening and on study, and CT or MRI and collection of blood samples throughout the trial. Patients may also undergo tumor biopsy during screening and on study. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Echocardiography Test; Procedure: Magnetic Resonance Imaging; Procedure: Multigated Acquisition Scan; Drug: Neratinib Maleate; Drug: Palbociclib |
| EAY191-S3 (activating AKT mutation) | Experimental | Patients receive paclitaxel IV on days 1, 8, and 15 and ipatasertib PO on days 1-21 of each cycle. Treatment repeats every 28 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or MRI and blood collection throughout the trial. Patients also undergo a tumor biopsy during screening and optionally during follow-up. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Ipatasertib; Procedure: Magnetic Resonance Imaging; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accrual of patients to ComboMATCH treatment trials
Will be estimated over time and considered in relationship to changes in treatment trial cohort status (activations, suspensions, terminations).
Measured: Up to 8 years
Assignment of patients to ComboMATCH treatment trials
Will be estimated over time and considered in relationship to changes in treatment trial cohort status (activations, suspensions, terminations).
Measured: Up to 8 years
Enrollment rates to ComboMATCH treatment trials
Will be estimated over time and considered in relationship to changes in treatment trial cohort status (activations, suspensions, terminations).
Measured: Up to 8 years
Secondary outcomes (1)
Rate of positive outcomes within the treatment trial defined cohorts
For each cohort in each treatment trial there is a defined primary efficacy endpoint (usually progression free survival [PFS] or overall response rate) and defined primary analysis for evaluating the primary endpoint. As cohorts are completed, whether they meet the criteria for a positive primary outcome will be determined. Positive treatment cohort outcome (on primary endpoint) will be analyzed as a binary random variable. The raw proportion of treatment cohorts with positive outcomes and an exact binomial confidence interval will be computed. If there are a sufficient number of treatment cohorts, logistic regression analysis will be performed examining the relationship of treatment cohort characteristics with successful outcomes. The goal is to achieve a rate of at least 30% with positive outcomes, both overall and in the subset of treatment trials based on in vivo models.
Measured: Up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start7 Apr 2023
- Primary completion1 Jul 2030 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- James M Ford, Principal investigator, ECOG-ACRIN Cancer Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05564377
- Sponsor's protocol ID
- NCI-2022-06842
- Other IDs
- NCI-2022-06842, EAY191, EAY191, U10CA180820
- Status last verified
- Sep 2026
- First submitted
- 27 Sep 2022
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Analysis for Combination Therapy Choice (ComboMATCH)
- ClinicalTrials.gov ID
- NCT05564377
- Acronym / sponsor ID
- NCI-2022-06842
- Conditions
- Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Locally Advanced Malignant Solid Neoplasm, Malignant Female Reproductive System Neoplasm, Metastatic HER2-Negative Breast Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,900 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 7 Apr 2023 (actual)
- Primary completion
- 1 Jul 2030 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This ComboMATCH patient screening trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. Patients with solid tumors that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment that has been shown to prolong overall survival may be candidates for these trials. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with some genetic changes or abnormalities (mutations) may benefit from treatment that targets that particular genetic mutation. ComboMATCH is designed to match patients to a treatment that may work to control their tumor and may help doctors plan better treatment for patients with locally advanced or advanced solid tumors.
Detailed description
PRIMARY OBJECTIVE:
- To register, allocate, and assign patients to ComboMATCH treatment trials.
SECONDARY OBJECTIVES:
- To evaluate the rate of positive outcomes in defined cohorts within treatment trials of treatment combinations including targeted therapies for molecularly defined populations, and also in the subset of treatment trials where the treatments are supported by in vivo models.
II. To perform quality control of the patients registered in the form of pathological confirmation of disease and sub-type to confirm diagnosis and treatment arm allocation.
SECONDARY CORRELATIVE OBJECTIVES:
- Assess the concordance of the central molecular characterization of the pre-treatment biopsy samples with the genetic readouts from the Designated Laboratories (DLs) for patients enrolled on the ComboMATCH treatment trials.
II. To assess how the registration diagnostic tumor mutation profile and pre-treatment biopsy profile compare to the circulating tumor-derived deoxyribonucleic acid (ctDNA) mutation profile from plasma.
EXPLORATORY OBJECTIVE:
- Assess association between ComboMATCH treatment trials outcomes (positive or negative) with the type of rationale for the selected drug combinations and the type of rationale for the gene variant/combination for selection (e.g., whether the trial was based on targeted therapies for molecularly defined populations, those that were supported by in vivo models, and those that were supported by empiric clinical data).
OUTLINE:
REGISTRATION: Patients undergo tumor mutational screening of previously-collected tumor samples for specific, pre-defined mutations, amplifications, or translocations of interest via tumor sequencing. Patients who are 18 years or older and have biopsiable disease undergo a new biopsy for research purposes prior to initiating treatment on the ComboMATCH treatment trial.
TREATMENT: Patients with mutations targeted to investigational combination therapies are assigned to 1 of 20 treatment subprotocols.
EAY191-N4: Patients with RAS pathway mutant ovarian or endometrial cancer are randomized to 1 of 2 arms.
ARM I: Patients receive selumetinib orally (PO) twice daily (BID) and olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo a tumor biopsy and blood collection during screening and on study, as well as echocardiogram (ECHO) or multigated acquisition (MUGA), and computed tomography (CT) scans throughout the trial. Patients may undergo bone marrow aspiration or biopsy as clinically indicated.
ARM II: Patients receive selumetinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience progression may elect to cross over to Arm I provided they have not had dose limiting toxicities to monotherapy selumetinib. Patients also undergo a tumor biopsy and blood collection during screening and on study, as well as ECHO or MUGA, and CT scans throughout the trial. Patients may undergo bone marrow aspiration or biopsy as clinically indicated.
EAY191-N2: Patients with inactivating or inferred inactivating NF1 alterations, and hormone receptor positive, HER2-negative metastatic breast cancer. Patients who are fulvestrant naive are assigned to Cohort I, while patients who are fulvestrant resistant are assigned to Cohort II.
COHORT I: Patients are randomized to 1 of 2 arms.
ARM I:Patients receive fulvestrant intramuscularly (IM) on day 1 and day 15 of cycle 1 and day 1 of subsequent cycles and binimetinib PO BID on days 15 to 28 of cycle 1 and day 1 through 28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT, magnetic resonance imaging (MRI), or bone scan, ECHO or MUGA, and tumor biopsy, as well as possible blood sample collection during screening and on study.
ARM II: Patients receive fulvestrant IM on day 1 and day 15 of cycle 1 and day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who progress on fulvestrant alone may migrate to cohort II if they meet the migration eligibility criteria. Patients not willing to migrate to cohort II will have further therapy at the investigator's discretion. Patients undergo a CT, MRI, or bone scan and tumor biopsy, as well as ECHO or MUGA and possible blood sample collection during screening and on study.
COHORT II: Patients receive fulvestrant IM on day 1 of each cycle and binimetinib PO BID on days 15-28 of cycle 1 and day 1 through 28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT, MRI, or bone scan, ECHO or MUGA and tumor biopsy, as well as possible blood sample collection during screening and on study.
EAY191-E4: Patients with solid tumors who previously underwent taxane therapy.
Patients receive nilotinib hydrochloride monohydrate PO BID on days 1-28 and paclitaxel intravenously (IV) over 1 hour on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI during screening or cycle 1 day 1, every 2 cycles for 1 year, every 3 cycles for patients on study for more than 1 year, and every 4 cycles for patients on study for more than 3 years and may also undergo CT or MRI during follow-up every 3 months for 2 years and then every 6 months for 1 year if clinically indicated. Patients also undergo collection of blood samples at baseline, cycle 2 day 1, and optionally at progression as well as tumor biopsy at baseline and optionally at progression.
EAY191-A3: Patients with KRAS/NRAS/BRAF mutated low-grade serous ovarian cancer (LGSOC) naive to MEK or CDK4/6 inhibitor therapy are randomized to either combination cohort 1 or monotherapy cohort 1. Patients with LGSOC who have received prior MEK inhibitor therapy are assigned to combination cohort 2. Patients with KRAS/NRAS/HRAS/non-V600E BRAF mutated pancreatic cancer are assigned to combination cohort 3. Patients with all other KRAS/NRAS/HRAS mutated tumor types (excluding LGSOC, non-small cell lung cancer, colorectal cancer, pancreatic, and melanoma) are assigned to combination cohort 4.
COMBINATION COHORTS 1, 2, 3, 4: Patients receive palbociclib PO and binimetinib PO throughout the trial. Patients may also undergo biopsy at screening and undergo MRI, CT, bone scan, and collection of blood samples during screening, on study, and/or during follow up.
MONOTHERAPY COHORT 1: Patients receive binimetinib PO throughout the trial. Patients may also undergo biopsy at screening and undergo MRI, CT, bone scan, and collection of blood samples during screening, on study, and/or during follow up.
EAY191-S3: Patients with an activating AKT mutation solid tumor.
Patients receive paclitaxel IV on days 1, 8, and 15 and ipatasertib PO on days 1-21 of each cycle. Treatment repeats every 28 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or MRI and blood collection throughout the trial. Patients also undergo a tumor biopsy during screening and optionally during follow-up.
EAY191-A6: Patients with RAS/RAF/MEK/ERK mutant biliary tract cancers are randomized to 1 of 2 arms.
ARM 1: Patients receive leucovorin IV, oxaliplatin IV, and fluorouracil IV on study. Patients undergo echocardiogram (ECHO) and multigated acquisition scan (MUGA) during screening and on study, a CT with contrast, MRI, or a fludeoxyglucose F-18 positron emission tomography (FDG-PET) during screening, collection of blood during screening and on study, and a biopsy during screening. Patients may also undergo brain MRI or CT during screening and on study, bone scans on study, and biopsy on study if clinically indicated.
ARM 2: Patients receive binimetinib PO, leucovorin IV, oxaliplatin IV, and fluorouracil IV on study. Patients undergo ECHO and MUGA during screening and on study, a CT with contrast, MRI, or an FDG-PET during screening, collection of blood during screening and on study, and a biopsy during screening. Patients may also undergo brain MRI or CT during screening and on study, bone scans on study, and biopsy on study if clinically indicated.
EAY191-E5: Patients are assigned to 1 of 2 cohorts.
COHORT I: Patients who have never received a KRAS G12C inhibitor are randomized to arms A or B.
ARM A: Patients receive sotorasib PO once daily (QD) on days 1-28 and panitumumab intravenously IV on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples, biopsy, and CT or MRI on study.
ARM B: Patients receive sotorasib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross-over to cohort II. Patients also undergo collection of blood samples, biopsy, and CT or MRI on study.
COHORT II: Patients who have received a KRAS G12C inhibitor are assigned to arm C.
ARM C: Patients receive combination therapy as in Arm A.
EAY191-A2: Patients are assigned to 1 of 3 cohorts.
COHORT 1: PARP-inhibitor naive patients are assigned to Arm A.
ARM A: Patients receive olaparib PO BID and alpelisib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression.
COHORT 2: PARP-inhibitor naive patients are randomized to 1 of 2 arms.
ARM B: Patients receive olaparib PO BID and alpelisib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression.
ARM C: Patients receive olaparib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients experiencing disease progression have the option to migrate to Cohort 3, Arm D. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression.
COHORT 3: PARP-inhibitor resistant patients are assigned to Arm D.
ARM D: Patients receive olaparib PO BID and alpelisib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression.
EAY191-N5: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive neratinib maleate PO QD on days 1-14 of cycle 0 in the absence of disease progression or unacceptable toxicity. Patients then receive neratinib maleate PO QD on days 1-28 of each subsequent cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience progression may crossover to Arm II. Patients undergo ECHO or MUGA during screening and on study, and CT or MRI and collection of blood samples throughout the trial. Patients may also undergo tumor biopsy during screening and on study.
ARM II: Patients receive neratinib maleate PO QD on days 1-14 of cycle 0 in the absence of disease progression or unacceptable toxicity. Patients then receive neratinib maleate PO QD on days 1-28 and palbociclib PO QD on days 1-21 of each subsequent cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening and on study, and CT or MRI and collection of blood samples throughout the trial. Patients may also undergo tumor biopsy during screening and on study.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 20
| Arm | Type | Receives |
|---|---|---|
| EAY191-A2 (Cohort 1, Arm A) | Experimental | Drug: Alpelisib, Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Bone Scan, Procedure: Computed Tomography, Procedure: Magnetic Resonance Imaging, Drug: Olaparib, Procedure: Positron Emission TomographyCohort 1, Arm A: Patients receive olaparib PO BID and alpelisib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression. |
| EAY191-A2 (Cohort 2, Arm B) | Experimental | Drug: Alpelisib, Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Bone Scan, Procedure: Computed Tomography, Procedure: Magnetic Resonance Imaging, Drug: Olaparib, Procedure: Positron Emission TomographyCohort 2, Arm B: Patients receive olaparib PO BID and alpelisib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression. |
| EAY191-A2 (Cohort 2, Arm C) | Experimental | Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Bone Scan, Procedure: Computed Tomography, Procedure: Magnetic Resonance Imaging, Drug: Olaparib, Procedure: Positron Emission TomographyCohort 2, Arm C: Patients receive olaparib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients experiencing disease progression have the option to migrate to Cohort 3, Arm D. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression. |
| EAY191-A2 (Cohort 3, Arm D) | Experimental | Drug: Alpelisib, Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Bone Scan, Procedure: Computed Tomography, Drug: Olaparib, Procedure: Positron Emission TomographyCohort 3, Arm D: Patients receive olaparib PO BID and alpelisib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression. |
| EAY191-A3 Combo Cohorts 1, 2, 3, 4 (palbociclib, binimetinib) | Experimental | Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Bone Scan, Procedure: Computed Tomography, Procedure: Magnetic Resonance Imaging, Drug: PalbociclibPatients receive palbociclib PO and binimetinib PO throughout the trial. Patients may also undergo biopsy at screening and undergo MRI, CT, bone scan, and collection of blood samples during screening, on study, and/or during follow up. |
| EAY191-A3 Monotherapy Cohort 1 (binimetinib) | Experimental | Drug: Binimetinib, Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Bone Scan, Procedure: Computed Tomography, Procedure: Magnetic Resonance ImagingPatients receive binimetinib PO throughout the trial. Patients may also undergo biopsy at screening and undergo MRI, CT, bone scan, and collection of blood samples during screening, on study, and/or during follow up. |
| EAY191-A6 Arm I (RAS/RAF/MEK/ERK mutations) | Experimental | Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Bone Scan, Procedure: Computed Tomography, Procedure: Echocardiography Test, Drug: Fluorouracil, Drug: Leucovorin, Procedure: Magnetic Resonance Imaging, Procedure: Multigated Acquisition Scan, Drug: Oxaliplatin, Procedure: Positron Emission TomographyPatients receive leucovorin IV, oxaliplatin IV, and fluorouracil IV on study. Patients undergo ECHO and MUGA during screening and on study, a CT with contrast, MRI, or a FDG-PET during screening, collection of blood during screening and on study, and a biopsy during screening. Patients may also undergo brain MRI or CT during screening and on study, bone scans on study, and biopsy on study if clinically indicated. |
| EAY191-A6 Arm II (RAS/RAF/MEK/ERK mutations) | Experimental | Drug: Binimetinib, Procedure: Biospecimen Collection, Procedure: Bone Scan, Procedure: Computed Tomography, Procedure: Echocardiography Test, Drug: Fluorouracil, Drug: Leucovorin, Procedure: Magnetic Resonance Imaging, Procedure: Multigated Acquisition Scan, Drug: Oxaliplatin, Procedure: Positron Emission TomographyPatients receive binimetinib PO, leucovorin IV, oxaliplatin IV, and fluorouracil IV on study. Patients undergo ECHO and MUGA during screening and on study, a CT with contrast, MRI, or an FDG-PET during screening, collection of blood during screening and on study, and a biopsy during screening. Patients may also undergo brain MRI or CT during screening and on study, bone scans on study, and biopsy on study if clinically indicated |
| EAY191-E4 (taxane therapy) | Experimental | Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Computed Tomography, Procedure: Magnetic Resonance Imaging, Drug: Nilotinib Hydrochloride Monohydrate, Drug: PaclitaxelPatients receive nilotinib hydrochloride monohydrate PO BID on days 1-28 and paclitaxel IV over 1 hour on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI during screening or cycle 1 day 1, every 2 cycles for 1 year, every 3 cycles for patients on study for more than 1 year, and every 4 cycles for patients on study for more than 3 years and may also undergo CT or MRI during follow-up every 3 months for 2 years and then every 6 months for 1 year if clinically indicated. Patients also undergo collection of blood samples at baseline, cycle 2 day 1, and optionally at progression as well as tumor biopsy at baseline and optionally at progression. |
| EAY191-E5 Cohort I Arm A (sotorasib, panitumumab) | Experimental | Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Computed Tomography, Procedure: Magnetic Resonance Imaging, Biological: Panitumumab, Drug: SotorasibPatients receive sotorasib PO QD on days 1-28 and panitumumab IV on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples, biopsy, and CT or MRI on study. |
| EAY191-E5 Cohort I Arm B (sotorasib) | Active comparator | Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Computed Tomography, Procedure: Magnetic Resonance Imaging, Drug: SotorasibPatients receive sotorasib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross-over to cohort II. Patients also undergo collection of blood samples, biopsy, and CT or MRI on study. |
| EAY191-E5 Cohort II (sotorasib) | Experimental | Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Computed Tomography, Procedure: Magnetic Resonance Imaging, Biological: Panitumumab, Drug: SotorasibPatients receive combination therapy as in EAY191-E5 Arm A. |
| EAY191-N2 Cohort I (Arm I) (NF1 mutations) | Experimental | Drug: Binimetinib, Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Bone Scan, Procedure: Computed Tomography, Procedure: Echocardiography Test, Drug: Fulvestrant, Procedure: Magnetic Resonance Imaging, Procedure: Multigated Acquisition ScanPatients receive fulvestrant IM on day 1 and day 15 of cycle 1 and day 1 of subsequent cycles and binimetinib PO BID on days 15 to 28 of cycle 1 and day 1 through 28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT, MRI, or bone scan, ECHO or MUGA, and tumor biopsy, as well as possible blood sample collection during screening and on study. |
| EAY191-N2 Cohort I (Arm II) (NF1 mutations) | Experimental | Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Bone Scan, Procedure: Computed Tomography, Procedure: Echocardiography Test, Drug: Fulvestrant, Procedure: Magnetic Resonance Imaging, Procedure: Multigated Acquisition ScanPatients receive fulvestrant IM on day 1 and day 15 of cycle 1 and day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who progress on fulvestrant alone may migrate to cohort II if they meet the migration eligibility criteria. Patients not willing to migrate to cohort II will have further therapy at the investigator's discretion. Patients undergo a CT, MRI, or bone scan and tumor biopsy, as well as ECHO or MUGA and possible blood sample collection during screening and on study. |
| EAY191-N2 Cohort II (NF1 mutations) | Experimental | Drug: Binimetinib, Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Bone Scan, Procedure: Computed Tomography, Procedure: Echocardiography Test, Drug: Fulvestrant, Procedure: Magnetic Resonance Imaging, Procedure: Multigated Acquisition ScanPatients receive fulvestrant IM on day 1 of each cycle and binimetinib PO BID on days 15-28 of cycle 1 and day 1 through 28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT, MRI, or bone scan, ECHO or MUGA and tumor biopsy, as well as possible blood sample collection during screening and on study. |
| EAY191-N4 Arm I (RAS pathway mutations) | Experimental | Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Bone Marrow Aspiration, Procedure: Bone Marrow Biopsy, Procedure: Computed Tomography, Procedure: Echocardiography Test, Procedure: Multigated Acquisition Scan, Procedure: Mutation Carrier Screening, Drug: Olaparib, Drug: Selumetinib SulfatePatients receive selumetinib PO BID and olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo a tumor biopsy and blood collection during screening and on study, as well as ECHO or MUGA, and CT scans throughout the trial. Patients may undergo bone marrow aspiration or biopsy as clinically indicated. |
| EAY191-N4 Arm II (RAS pathway mutations) | Active comparator | Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Bone Marrow Aspiration, Procedure: Bone Marrow Biopsy, Procedure: Computed Tomography, Procedure: Echocardiography Test, Procedure: Multigated Acquisition Scan, Procedure: Mutation Carrier Screening, Drug: Selumetinib SulfatePatients receive selumetinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience progression may elect to cross over to Arm I provided they have not had dose limiting toxicities to monotherapy selumetinib. Patients also undergo a tumor biopsy and blood collection during screening and on study, as well as ECHO or MUGA, and CT scans throughout the trial. Patients may undergo bone marrow aspiration or biopsy as clinically indicated. |
| EAY191-N5 Arm I (neratinib maleate) | Active comparator | Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Computed Tomography, Procedure: Echocardiography Test, Procedure: Magnetic Resonance Imaging, Procedure: Multigated Acquisition Scan, Drug: Neratinib MaleatePatients receive neratinib maleate PO QD on days 1-14 of cycle 0 in the absence of disease progression or unacceptable toxicity. Patients then receive neratinib maleate PO QD on days 1-28 of each subsequent cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience progression may crossover to Arm II. Patients undergo ECHO or MUGA during screening and on study, and CT or MRI and collection of blood samples throughout the trial. Patients may also undergo tumor biopsy during screening and on study. |
| EAY191-N5 Arm II (neratinib maleate,palbociclib) | Experimental | Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Computed Tomography, Procedure: Echocardiography Test, Procedure: Magnetic Resonance Imaging, Procedure: Multigated Acquisition Scan, Drug: Neratinib Maleate, Drug: PalbociclibPatients receive neratinib maleate PO QD on days 1-14 of cycle 0 in the absence of disease progression or unacceptable toxicity. Patients then receive neratinib maleate PO QD on days 1-28 and palbociclib PO QD on days 1-21 of each subsequent cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening and on study, and CT or MRI and collection of blood samples throughout the trial. Patients may also undergo tumor biopsy during screening and on study. |
| EAY191-S3 (activating AKT mutation) | Experimental | Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Computed Tomography, Drug: Ipatasertib, Procedure: Magnetic Resonance Imaging, Drug: PaclitaxelPatients receive paclitaxel IV on days 1, 8, and 15 and ipatasertib PO on days 1-21 of each cycle. Treatment repeats every 28 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or MRI and blood collection throughout the trial. Patients also undergo a tumor biopsy during screening and optionally during follow-up. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- Patient must have measurable disease
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-2 OR patient must have Lansky performance status of >= 50% or Karnofsky performance status of >= 50%
- Patient must be deemed potentially eligible for a ComboMATCH Treatment Trial as assessed by the enrolling provider
- All patients must have sequencing results available from a National Cancer Institute (NCI) credentialed Designated Laboratory (DL)
- Patients must have locally advanced or advanced histologically documented solid tumors requiring therapy and meet one of the following criteria:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlpelisibAlso: BYL 719, BYL-719, BYL719, Phosphoinositide 3-kinase Inhibitor BYL719Given PO | Drug | EAY191-A2 (Cohort 1, Arm A), EAY191-A2 (Cohort 2, Arm B), EAY191-A2 (Cohort 3, Arm D) |
| BinimetinibAlso: ARRY 162, ARRY 438162, ARRY-162, ARRY-438162Given PO | Drug | EAY191-A3 Monotherapy Cohort 1 (binimetinib), EAY191-A6 Arm II (RAS/RAF/MEK/ERK mutations), EAY191-N2 Cohort I (Arm I) (NF1 mutations), EAY191-N2 Cohort II (NF1 mutations) |
| Biopsy ProcedureAlso: Biopsy, BIOPSY_TYPE, BxUndergo biopsy | Procedure or surgery | EAY191-A2 (Cohort 1, Arm A), EAY191-A2 (Cohort 2, Arm B), EAY191-A2 (Cohort 2, Arm C), EAY191-A2 (Cohort 3, Arm D), EAY191-A3 Combo Cohorts 1, 2, 3, 4 (palbociclib, binimetinib), EAY191-A3 Monotherapy Cohort 1 (binimetinib), EAY191-A6 Arm I (RAS/RAF/MEK/ERK mutations), EAY191-E4 (taxane therapy), EAY191-E5 Cohort I Arm A (sotorasib, panitumumab), EAY191-E5 Cohort I Arm B (sotorasib), EAY191-E5 Cohort II (sotorasib), EAY191-N2 Cohort I (Arm I) (NF1 mutations), EAY191-N2 Cohort I (Arm II) (NF1 mutations), EAY191-N2 Cohort II (NF1 mutations), EAY191-N4 Arm I (RAS pathway mutations), EAY191-N4 Arm II (RAS pathway mutations), EAY191-N5 Arm I (neratinib maleate), EAY191-N5 Arm II (neratinib maleate,palbociclib), EAY191-S3 (activating AKT mutation) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen CollectionUndergo blood collection | Procedure or surgery | EAY191-A2 (Cohort 1, Arm A), EAY191-A2 (Cohort 2, Arm B), EAY191-A2 (Cohort 2, Arm C), EAY191-A2 (Cohort 3, Arm D), EAY191-A3 Combo Cohorts 1, 2, 3, 4 (palbociclib, binimetinib), EAY191-A3 Monotherapy Cohort 1 (binimetinib), EAY191-A6 Arm I (RAS/RAF/MEK/ERK mutations), EAY191-A6 Arm II (RAS/RAF/MEK/ERK mutations), EAY191-E4 (taxane therapy), EAY191-E5 Cohort I Arm A (sotorasib, panitumumab), EAY191-E5 Cohort I Arm B (sotorasib), EAY191-E5 Cohort II (sotorasib), EAY191-N2 Cohort I (Arm I) (NF1 mutations), EAY191-N2 Cohort I (Arm II) (NF1 mutations), EAY191-N2 Cohort II (NF1 mutations), EAY191-N4 Arm I (RAS pathway mutations), EAY191-N4 Arm II (RAS pathway mutations), EAY191-N5 Arm I (neratinib maleate), EAY191-N5 Arm II (neratinib maleate,palbociclib), EAY191-S3 (activating AKT mutation) |
| Bone Marrow AspirationUndergo bone marrow aspiration | Procedure or surgery | EAY191-N4 Arm I (RAS pathway mutations), EAY191-N4 Arm II (RAS pathway mutations) |
| Bone Marrow BiopsyAlso: Biopsy of Bone Marrow, Biopsy, Bone MarrowUndergo bone marrow biopsy | Procedure or surgery | EAY191-N4 Arm I (RAS pathway mutations), EAY191-N4 Arm II (RAS pathway mutations) |
| Bone ScanAlso: Bone ScintigraphyUndergo bone scan | Procedure or surgery | EAY191-A2 (Cohort 1, Arm A), EAY191-A2 (Cohort 2, Arm B), EAY191-A2 (Cohort 2, Arm C), EAY191-A2 (Cohort 3, Arm D), EAY191-A3 Combo Cohorts 1, 2, 3, 4 (palbociclib, binimetinib), EAY191-A3 Monotherapy Cohort 1 (binimetinib), EAY191-A6 Arm I (RAS/RAF/MEK/ERK mutations), EAY191-A6 Arm II (RAS/RAF/MEK/ERK mutations), EAY191-N2 Cohort I (Arm I) (NF1 mutations), EAY191-N2 Cohort I (Arm II) (NF1 mutations), EAY191-N2 Cohort II (NF1 mutations) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT | Procedure or surgery | EAY191-A2 (Cohort 1, Arm A), EAY191-A2 (Cohort 2, Arm B), EAY191-A2 (Cohort 2, Arm C), EAY191-A2 (Cohort 3, Arm D), EAY191-A3 Combo Cohorts 1, 2, 3, 4 (palbociclib, binimetinib), EAY191-A3 Monotherapy Cohort 1 (binimetinib), EAY191-A6 Arm I (RAS/RAF/MEK/ERK mutations), EAY191-A6 Arm II (RAS/RAF/MEK/ERK mutations), EAY191-E4 (taxane therapy), EAY191-E5 Cohort I Arm A (sotorasib, panitumumab), EAY191-E5 Cohort I Arm B (sotorasib), EAY191-E5 Cohort II (sotorasib), EAY191-N2 Cohort I (Arm I) (NF1 mutations), EAY191-N2 Cohort I (Arm II) (NF1 mutations), EAY191-N2 Cohort II (NF1 mutations), EAY191-N4 Arm I (RAS pathway mutations), EAY191-N4 Arm II (RAS pathway mutations), EAY191-N5 Arm I (neratinib maleate), EAY191-N5 Arm II (neratinib maleate,palbociclib), EAY191-S3 (activating AKT mutation) |
| Echocardiography TestAlso: EC, EchocardiographyUndergo ECHO | Procedure or surgery | EAY191-A6 Arm I (RAS/RAF/MEK/ERK mutations), EAY191-A6 Arm II (RAS/RAF/MEK/ERK mutations), EAY191-N2 Cohort I (Arm I) (NF1 mutations), EAY191-N2 Cohort I (Arm II) (NF1 mutations), EAY191-N2 Cohort II (NF1 mutations), EAY191-N4 Arm I (RAS pathway mutations), EAY191-N4 Arm II (RAS pathway mutations), EAY191-N5 Arm I (neratinib maleate), EAY191-N5 Arm II (neratinib maleate,palbociclib) |
| FluorouracilAlso: 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedioneGiven IV | Drug | EAY191-A6 Arm I (RAS/RAF/MEK/ERK mutations), EAY191-A6 Arm II (RAS/RAF/MEK/ERK mutations) |
| FulvestrantAlso: Faslodex, Faslodex(ICI 182,780), ICI 182,780, ICI 182780Given IM | Drug | EAY191-N2 Cohort I (Arm I) (NF1 mutations), EAY191-N2 Cohort I (Arm II) (NF1 mutations), EAY191-N2 Cohort II (NF1 mutations) |
| IpatasertibAlso: GDC 0068, GDC-0068, GDC0068, RG 7440Given PO | Drug | EAY191-S3 (activating AKT mutation) |
| LeucovorinAlso: Folinic acidGiven IV | Drug | EAY191-A6 Arm I (RAS/RAF/MEK/ERK mutations), EAY191-A6 Arm II (RAS/RAF/MEK/ERK mutations) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo MRI | Procedure or surgery | EAY191-A2 (Cohort 1, Arm A), EAY191-A2 (Cohort 2, Arm B), EAY191-A2 (Cohort 2, Arm C), EAY191-A3 Combo Cohorts 1, 2, 3, 4 (palbociclib, binimetinib), EAY191-A3 Monotherapy Cohort 1 (binimetinib), EAY191-A6 Arm I (RAS/RAF/MEK/ERK mutations), EAY191-A6 Arm II (RAS/RAF/MEK/ERK mutations), EAY191-E4 (taxane therapy), EAY191-E5 Cohort I Arm A (sotorasib, panitumumab), EAY191-E5 Cohort I Arm B (sotorasib), EAY191-E5 Cohort II (sotorasib), EAY191-N2 Cohort I (Arm I) (NF1 mutations), EAY191-N2 Cohort I (Arm II) (NF1 mutations), EAY191-N2 Cohort II (NF1 mutations), EAY191-N5 Arm I (neratinib maleate), EAY191-N5 Arm II (neratinib maleate,palbociclib), EAY191-S3 (activating AKT mutation) |
| Multigated Acquisition ScanAlso: Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool ScanUndergo MUGA | Procedure or surgery | EAY191-A6 Arm I (RAS/RAF/MEK/ERK mutations), EAY191-A6 Arm II (RAS/RAF/MEK/ERK mutations), EAY191-N2 Cohort I (Arm I) (NF1 mutations), EAY191-N2 Cohort I (Arm II) (NF1 mutations), EAY191-N2 Cohort II (NF1 mutations), EAY191-N4 Arm I (RAS pathway mutations), EAY191-N4 Arm II (RAS pathway mutations), EAY191-N5 Arm I (neratinib maleate), EAY191-N5 Arm II (neratinib maleate,palbociclib) |
| Mutation Carrier ScreeningUndergo tumor mutational screening | Procedure or surgery | EAY191-N4 Arm I (RAS pathway mutations), EAY191-N4 Arm II (RAS pathway mutations) |
| Neratinib MaleateAlso: 2-Butenamide, N-(4-((3-chloro-4-(2-pyridinylmethoxy)phenyl)amino)-3-cyano-7-ethoxy-6-quinolinyl)-4-(dimethylamino)-, (2E)-, (2Z)-2-butenedioate (1:1), HKI-272 Maleate, NERATINIB MALEATE ANHYDROUS, NerlynxGiven PO | Drug | EAY191-N5 Arm I (neratinib maleate), EAY191-N5 Arm II (neratinib maleate,palbociclib) |
| Nilotinib Hydrochloride MonohydrateAlso: AMN 107, AMN-107, AMN107, Nilotinib Monohydrochloride MonohydrateGiven PO | Drug | EAY191-E4 (taxane therapy) |
| OlaparibAlso: AZD 2281, AZD-2281, AZD2281, KU 0059436Given PO | Drug | EAY191-A2 (Cohort 1, Arm A), EAY191-A2 (Cohort 2, Arm B), EAY191-A2 (Cohort 2, Arm C), EAY191-A2 (Cohort 3, Arm D), EAY191-N4 Arm I (RAS pathway mutations) |
| OxaliplatinAlso: 1-OHP, Ai Heng, Aiheng, DacotinGiven IV | Drug | EAY191-A6 Arm I (RAS/RAF/MEK/ERK mutations), EAY191-A6 Arm II (RAS/RAF/MEK/ERK mutations) |
| PaclitaxelAlso: Anzatax, Asotax, Bristaxol, PraxelGiven PO or IV | Drug | EAY191-E4 (taxane therapy), EAY191-S3 (activating AKT mutation) |
| PalbociclibAlso: 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one, Ibrance, PD 0332991, PD 332991Given PO | Drug | EAY191-A3 Combo Cohorts 1, 2, 3, 4 (palbociclib, binimetinib), EAY191-N5 Arm II (neratinib maleate,palbociclib) |
| PanitumumabAlso: ABX-EGF, ABX-EGF Monoclonal Antibody, ABX-EGF, Clone E7.6.3, E7.6.3Given IV | Biological | EAY191-E5 Cohort I Arm A (sotorasib, panitumumab), EAY191-E5 Cohort II (sotorasib) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)Undergo PET | Procedure or surgery | EAY191-A2 (Cohort 1, Arm A), EAY191-A2 (Cohort 2, Arm B), EAY191-A2 (Cohort 2, Arm C), EAY191-A2 (Cohort 3, Arm D), EAY191-A6 Arm I (RAS/RAF/MEK/ERK mutations), EAY191-A6 Arm II (RAS/RAF/MEK/ERK mutations) |
| Selumetinib SulfateAlso: AZD-6244 Hydrogen Sulfate, AZD6244 Hydrogen Sulfate, AZD6244 Hydrogen Sulphate, KoselugoGiven PO | Drug | EAY191-N4 Arm I (RAS pathway mutations), EAY191-N4 Arm II (RAS pathway mutations) |
| SotorasibAlso: AMG 510, AMG-510, AMG510, LumakrasGiven PO | Drug | EAY191-E5 Cohort I Arm A (sotorasib, panitumumab), EAY191-E5 Cohort I Arm B (sotorasib), EAY191-E5 Cohort II (sotorasib) |
Primary outcome
Accrual of patients to ComboMATCH treatment trials
Time frame: Up to 8 years
Will be estimated over time and considered in relationship to changes in treatment trial cohort status (activations, suspensions, terminations).
Assignment of patients to ComboMATCH treatment trials
Time frame: Up to 8 years
Will be estimated over time and considered in relationship to changes in treatment trial cohort status (activations, suspensions, terminations).
Enrollment rates to ComboMATCH treatment trials
Time frame: Up to 8 years
Will be estimated over time and considered in relationship to changes in treatment trial cohort status (activations, suspensions, terminations).
1 secondary outcome
Rate of positive outcomes within the treatment trial defined cohorts
Time frame: Up to 8 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes. NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
University of South Alabama Mitchell Cancer Institute
Mobile, United States
Alaska Women's Cancer Care
Anchorage, United States
James M Ford principal investigator
ECOG-ACRIN Cancer Research Group
484 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alpelisib, Binimetinib and Biopsy Procedure in people with Advanced Malignant Solid Neoplasm and Anatomic Stage III Breast Cancer AJCC v8, run by National Cancer Institute (NCI) at 484 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 484 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accrual of patients to ComboMATCH treatment trials (time frame: Up to 8 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.