Acral Lentiginous MelanomaPhase 2NCT04511013
A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases
A Phase 2 study testing Binimetinib, Encorafenib and Ipilimumab in people with Acral Lentiginous Melanoma and Clinical Stage IV Cutaneous Melanoma AJCC v8, run by SWOG Cancer Research Network at 331 sites in United States.
Trial summary
This phase II trial compares the effect of encorafenib, binimetinib, and nivolumab versus ipilimumab and nivolumab in treating patients with BRAF- V600 mutant melanoma that has spread to the brain (brain metastases). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acral Lentiginous Melanoma, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Cutaneous Melanoma
- What is being tested?
- Binimetinib, Encorafenib and Ipilimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 331 sitesUnited States
- Study dates
- 6 Jan 2021to 30 Jun 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have histologically and pathologically confirmed melanoma that has metastasized to the brain
- Any primary (cutaneous, acral/mucosal, etc) or unknown origin are permitted, except that participants with uveal primary are not eligible
- Participants must have BRAF-V600 mutant melanoma documented by a Clinical Laboratory Improvement Act (CLIA)-certified laboratory
- All participants must have an magnetic resonance imaging (MRI) of the brain within 28 days prior to registration and must have central nervous system metastases with at least one measurable brain metastasis >= 0.5 cm in size (per modified RECIST 1.1) that has not been irradiated, or progressed (in the opinion of the treating physician) after prior radiation therapy. Participating sites MUST use MRI slice thickness of =< 1.5 mm and are recommended to adhere to the 'minimum' Brain Tumor Imaging Protocol for Clinical Trials in Brain Metastases (BTIP-BM) compliant MRI acquisition protocol. Computed tomography (CT) of the head cannot substitute for brain MRI. (NOTE: All central nervous system [CNS] disease must be documented on BOTH the Brain Metastases Baseline Tumor Assessment Form, using modified RECIST, and the Baseline Tumor Assessment Form [RECIST 1.1] using RECIST 1.1.)
- Participants may have measurable or non-measurable extracranial disease. All measurable disease must be assessed within 28 days prior to randomization; all non-measurable disease must be assessed within 42 days prior to randomization. Please note, while any extracranial disease will also be assessed and followed, participants are NOT required to have extracranial disease for randomization. NOTE: All disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1). CNS disease must be documented on BOTH the Brain Metastases Baseline Tumor Assessment Form, using modified RECIST, and the Baseline Tumor Assessment Form (RECIST 1.1) using RECIST 1.1
- Participants may have leptomeningeal disease
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- Participants may be receiving corticosteroids for brain metastases at a dose of up to 8 mg of dexamethasone per day. The dose must not have exceeded 8 mg per day for at least 7 days prior to randomization
- Participants must have Zubrod performance status =< 2
- Participants must have complete history and physical examination within 28 days prior to randomization
- Participants must be able to swallow and retain pills
- Hemoglobin >= 8.0 g/dL (within 28 days prior to randomization)
- Absolute neutrophil count >= 1,500/mcL (within 28 days prior to randomization)
- Platelets >= 75,000/mcL (within 28 days prior to randomization)
- Total bilirubin =< 1.5 institutional upper limit of normal (ULN) (within 28 days prior to randomization)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional ULN (in participants with liver metastases =< 5 x ULN) (within 28 days prior to randomization)
- Creatinine =< 2.0 institutional ULN (within 28 days prior to randomization)
- Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better
- Participants with a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- Participants with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 90 days prior to randomization
- Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with HCV infection who are currently on treatment must have an undetectable HCV viral load prior to randomization
- Participants must agree to participate in image banking. Images must be submitted via the Triad System
- Participants must be offered the opportunity to participate in specimen and blood collections
- Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
- As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
Who cannot join
- Participants must not have received prior systemic therapy for metastatic disease. Prior systemic therapy received only in the neoadjuvant and/or adjuvant setting (e.g., BRAF/MEK inhibitor therapy, anti-PD-1 therapy or anti-CTLA4 therapy, alfa-interferon, etc.) is permitted. If patients received prior neoadjuvant/adjuvant therapy, they must have had eventual disease relapse prior to randomization
- Participants must not have had prior radiation therapy within 7 days prior to randomization
- Participants must not be planning to require any additional form of systemic anti-tumor therapy for melanoma while on protocol treatment
- Participants must not be planning to use hormonal contraceptives
- Participants must not have a serious active infection requiring systemic therapy at time of randomization in the opinion of the treating physician
- Participants must not have active autoimmune disease that has required treatment in the past 6 months with use of biologic disease modifying agents (.e.g. infliximab, adalimumab). Patients on non-biologic disease modifying agents (e.g. methotrexate) or patients on corticosteroids =< 10 mg prednisone daily or equivalent (to treat auto-immune disease), or on replacement therapy (e.g., thyroxine, insulin) are eligible if deemed in the best interest of the patient by treating physician
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- Participants must not have had grade 3 or 4 immune-related adverse events on ipilimumab or nivolumab that required more than 12 weeks of immune suppression with corticosteroids
- Participants must not have had adverse events related to encorafenib and/or binimetinib specifically, that required discontinuation of one or both drugs. (Please note this does not apply to other BRAF/MEK inhibitor drugs.)
- Participants must not be pregnant or nursing. Women/men of reproductive potential must have agreed to use an effective method of contraception. (NOTE: Patients must agree to not use hormonal contraceptives, as encorafenib can result in decreased concentration and loss of efficacy.) A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
Trial locations and contacts
331 sites in 1 country. Contact the study team or a site near you to ask about taking part.
300 sites in 1 country
United States300 sites, 274 recruiting
- Recruiting
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, 98520
Site Public Contact, 360-412-8958, deidre.dillon@providence.org
Charles W. Drescher
- Recruiting
Saint Anthony's Health
Alton, Illinois, 62002
Site Public Contact, 618-463-5623
Jay W. Carlson
- Recruiting
Mary Greeley Medical Center
Ames, Iowa, 50010
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Recruiting
McFarland Clinic - Ames
Ames, Iowa, 50010
Site Public Contact, 515-239-4734, ksoder@mcfarlandclinic.com
Joseph J. Merchant
- Recruiting
Community Hospital of Anaconda
Anaconda, Montana, 59711
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Anchorage Radiation Therapy Center
Anchorage, Alaska, 99504
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Alaska Women's Cancer Care
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Anchorage Oncology Centre
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Katmai Oncology Group
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Providence Alaska Medical Center
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Site Public Contact, 800-865-1125
Christopher D. Lao
- Recruiting
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409
Site Public Contact, 715-623-9869, Juli.Alford@aspirus.org
Andrew J. Huang
- Recruiting
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, 80012
Site Public Contact, 303-777-2663, info@westernstatesncorp.org
Nicholas DiBella
- Suspended
The Medical Center of Aurora
Aurora, Colorado, 80012
- Recruiting
University of Colorado Hospital
Aurora, Colorado, 80045
Site Public Contact, 720-848-0650
Theresa M. Medina
- Recruiting
Rush - Copley Medical Center
Aurora, Illinois, 60504
Site Public Contact, 630-978-6212, Cancer.Research@rushcopley.com
Maria T. Grosse-Perdekamp
- Active, not recruiting
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, 33180
- Recruiting
Saint Alphonsus Medical Center-Baker City
Baker City, Oregon, 97814
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri, 63011
Site Public Contact, 314-251-7058
Jay W. Carlson
- Recruiting
Bronson Battle Creek
Battle Creek, Michigan, 49017
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen J. Yost
- Recruiting
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122
Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org
Ankit Mangla
- Recruiting
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
Site Public Contact, 360-788-8223
Charles W. Drescher
- Recruiting
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714
Site Public Contact, 800-523-3977, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
Saint Charles Health System
Bend, Oregon, 97701
Site Public Contact, 541-706-2909, nosall@stcharleshealthcare.org
Charles W. Drescher
- 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, 205-934-0220, tmyrick@uab.edu
Maya Khalil
- Recruiting
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Saint Elizabeth Boardman Hospital
Boardman, Ohio, 44512
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
John M. Schallenkamp
- Recruiting
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Site Public Contact, 208-381-2774, eslinget@slhs.org
Charles W. Drescher
- Recruiting
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613
Site Public Contact, 913-948-5588, aroland@kccop.org
Jay W. Carlson
- Recruiting
McFarland Clinic - Boone
Boone, Iowa, 50036
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Recruiting
Boulder Community Foothills Hospital
Boulder, Colorado, 80303
Site Public Contact, 303-777-2663, info@westernstatesncorp.org
Nicholas DiBella
- Recruiting
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304
Site Public Contact, 303-777-2663, info@westernstatesncorp.org
Nicholas DiBella
- Recruiting
Bozeman Deaconess Hospital
Bozeman, Montana, 59715
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Cox Cancer Center Branson
Branson, Missouri, 65616
Site Public Contact, 417-269-4520
Jay W. Carlson
- Recruiting
University of Michigan - Brighton Center for Specialty Care
Brighton, Michigan, 48116
Site Public Contact, 800-865-1125
Christopher D. Lao
- Active, not recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
- Recruiting
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505
Site Public Contact, 818-847-4793, Najee.Boucher@providence.org
Charles W. Drescher
- Suspended
Fairview Ridges Hospital
Burnsville, Minnesota, 55337
- Recruiting
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
John M. Schallenkamp
- Recruiting
Cambridge Medical Center
Cambridge, Minnesota, 55008
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Illinois CancerCare-Canton
Canton, Illinois, 61520
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Site Public Contact, 573-334-2230, sfmc@sfmc.net
Bryan A. Faller
- Recruiting
Southeast Cancer Center
Cape Girardeau, Missouri, 63703
Site Public Contact, 573-651-5550
Bryan A. Faller
- Recruiting
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902
Site Public Contact, 618-457-5200, clinical.research@sih.net
Bryan A. Faller
- Recruiting
Saint Anthony Regional Hospital
Carroll, Iowa, 51401
Site Public Contact, 515-689-7658, sbenson@iora.org
Joshua Lukenbill
- 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
Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado, 80112
Site Public Contact, 303-777-2663, info@westernstatesncorp.org
Nicholas DiBella
- Recruiting
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Suspended
Miami Valley Hospital South
Centerville, Ohio, 45459
- Recruiting
Centralia Oncology Clinic
Centralia, Illinois, 62801
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Saint Mary's Hospital
Centralia, Illinois, 62801
Site Public Contact, protocols@swog.org
Jay W. Carlson
- Recruiting
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531
Site Public Contact, 360-412-8958, deidre.dillon@providence.org
Charles W. Drescher
- Recruiting
Geauga Hospital
Chardon, Ohio, 44024
Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org
Ankit Mangla
- Recruiting
Cheyenne Regional Medical Center-West
Cheyenne, Wyoming, 82001
Site Public Contact, 303-777-2663, ccrp@co-cancerresearch.org
Nicholas DiBella
- Active, not recruiting
Northwestern University
Chicago, Illinois, 60611
- Recruiting
Adena Regional Medical Center
Chillicothe, Ohio, 45601
Site Public Contact, 877-779-7585, sheree@columbusccop.org
Timothy D. Moore
- Active, not recruiting
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219
- Recruiting
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Recruiting
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Recruiting
Wake Forest University at Clemmons
Clemmons, North Carolina, 27012
Site Public Contact, 888-716-9259
Pierre L. Triozzi
- Recruiting
Case Western Reserve University
Cleveland, Ohio, 44106
Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org
Ankit Mangla
- Recruiting
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, 28328
Site Public Contact, 919-587-9084, jfields@cancersmoc.com
Samer S. Kasbari
- Recruiting
Billings Clinic-Cody
Cody, Wyoming, 82414
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- Recruiting
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Site Public Contact, 800-293-5066, Jamesline@osumc.edu
Kari L. Kendra
- Recruiting
Mount Carmel East Hospital
Columbus, Ohio, 43213
Site Public Contact, 614-488-2118, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, 43214
Site Public Contact, 614-488-2118, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
Riverside Methodist Hospital
Columbus, Ohio, 43214
Site Public Contact, 614-566-4475, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
Grant Medical Center
Columbus, Ohio, 43215
Site Public Contact, 614-566-4475, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
The Mark H Zangmeister Center
Columbus, Ohio, 43219
Site Public Contact, 614-488-2118, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
Mount Carmel Health Center West
Columbus, Ohio, 43222
Site Public Contact, 614-234-5433, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
Doctors Hospital
Columbus, Ohio, 43228
Site Public Contact, 614-566-3275, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
Mercy Hospital
Coon Rapids, Minnesota, 55433
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Bay Area Hospital
Coos Bay, Oregon, 97420
Site Public Contact, 541-269-8392, cherie.cox@bayareahospital.org
Charles W. Drescher
- Active, not recruiting
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, 33146
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
Site Public Contact, 800-446-5532, Research@Carle.com
Maria T. Grosse-Perdekamp
- Suspended
Miami Valley Hospital
Dayton, Ohio, 45409
- Recruiting
Dayton Physician LLC-Miami Valley Hospital North
Dayton, Ohio, 45415
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Suspended
Miami Valley Hospital North
Dayton, Ohio, 45415
- 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
- Active, not recruiting
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442
- Recruiting
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015
Site Public Contact, 740-615-0227, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
Grady Memorial Hospital
Delaware, Ohio, 43015
Site Public Contact, 740-615-2403, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
The Women's Imaging Center
Denver, Colorado, 80209
Site Public Contact, 303-777-2663, info@westernstatesncorp.org
Nicholas DiBella
- Recruiting
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Site Public Contact, 303-777-2663, info@westernstatesncorp.org
Nicholas DiBella
- Recruiting
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218
Site Public Contact, 303-777-2663, info@westernstatesncorp.org
Nicholas DiBella
- Recruiting
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, 80218
Site Public Contact, 303-777-2663, info@westernstatesncorp.org
Nicholas DiBella
- Recruiting
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, 80220
Site Public Contact, 303-777-2663, info@westernstatesncorp.org
Nicholas DiBella
- Suspended
Rose Medical Center
Denver, Colorado, 80220
- Suspended
Western Surgical Care
Denver, Colorado, 80220
- Recruiting
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Site Public Contact, 515-241-6727
Joshua Lukenbill
- Recruiting
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309
Site Public Contact, 515-241-3305
Joshua Lukenbill
- Recruiting
Broadlawns Medical Center
Des Moines, Iowa, 50314
Site Public Contact, 515-282-2200
Joshua Lukenbill
- Recruiting
Iowa Lutheran Hospital
Des Moines, Iowa, 50316
Site Public Contact, 515-241-8704
Joshua Lukenbill
- Recruiting
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
Site Public Contact, 815-285-7800
Bryan A. Faller
- Recruiting
Epic Care-Dublin
Dublin, California, 94568
Site Public Contact, 925-875-1677
Lisa Bailey
- Recruiting
Columbus Oncology and Hematology Associates
Dublin, Ohio, 43016
Site Public Contact, 614-566-3275, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
Dublin Methodist Hospital
Dublin, Ohio, 43016
Site Public Contact, 800-752-9119, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Chady A. Leon
- Recruiting
Fairview Southdale Hospital
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, 206-215-3086, PCRC-NCORP@Swedish.org
Charles W. Drescher
- Recruiting
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Site Public Contact, 800-446-5532, Research@carle.com
Maria T. Grosse-Perdekamp
- Recruiting
Crossroads Cancer Center
Effingham, Illinois, 62401
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Bay Area Breast Surgeons Inc
Emeryville, California, 94608
Site Public Contact, 510-835-9900
Lisa Bailey
- Recruiting
Epic Care Partners in Cancer Care
Emeryville, California, 94608
Site Public Contact, 510-629-6682
Lisa Bailey
- Recruiting
Walter Knox Memorial Hospital
Emmett, Idaho, 83617
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
John M. Schallenkamp
- Recruiting
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado, 80113
Site Public Contact, 303-777-2663, info@westernstatesncorp.org
Nicholas DiBella
- Recruiting
Rocky Mountain Cancer Centers - Swedish
Englewood, Colorado, 80113
Site Public Contact, 303-777-2663, info@westernstatesncorp.org
Nicholas DiBella
- Recruiting
Swedish Medical Center
Englewood, Colorado, 80113
Site Public Contact, 303-777-2663, info@westernstatesncorp.org
Nicholas DiBella
- Recruiting
The Melanoma and Skin Cancer Institute
Englewood, Colorado, 80113
Site Public Contact, ryan.weight@theskincancerinstitute.com
Nicholas DiBella
- Recruiting
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Providence Regional Cancer Partnership
Everett, Washington, 98201
Site Public Contact, 425-261-3529, marilyn.birchman@providence.org
Charles W. Drescher
- Recruiting
Fairbanks Memorial Hospital
Fairbanks, Alaska, 99701
Site Public Contact, 907-458-3043, Veronica.Stevenson@foundationhealth.org
Nicholas DiBella
- Recruiting
Thomas Hospital
Fairhope, Alabama, 36532
Site Public Contact, 251-435-4584
Furhan Yunus
- Recruiting
Parkland Health Center - Farmington
Farmington, Missouri, 63640
Site Public Contact, 314-996-5569
Bryan A. Faller
- Recruiting
Armes Family Cancer Center
Findlay, Ohio, 45840
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Blanchard Valley Hospital
Findlay, Ohio, 45840
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Orion Cancer Care
Findlay, Ohio, 45840
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Recruiting
Trinity Regional Medical Center
Fort Dodge, Iowa, 50501
Site Public Contact, 515-574-8302
Joshua Lukenbill
- Recruiting
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
Site Public Contact, 800-378-9373
Jay W. Carlson
- Suspended
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
- Recruiting
Dayton Physicians LLC-Atrium
Franklin, Ohio, 45005
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Unity Hospital
Fridley, Minnesota, 55432
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
Site Public Contact, 208-381-2774, eslinget@slhs.org
Charles W. Drescher
- Recruiting
Central Ohio Breast and Endocrine Surgery
Gahanna, Ohio, 43230
Site Public Contact, 614-488-2745, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401
Site Public Contact, 309-344-2831
Bryan A. Faller
- Recruiting
Central Care Cancer Center - Garden City
Garden City, Kansas, 67846
Site Public Contact, 913-948-5588, aroland@kccop.org
Jay W. Carlson
- Recruiting
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, 27534
Site Public Contact, 919-587-9084, jfields@cancersmoc.com
Samer S. Kasbari
- Recruiting
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen J. Yost
- Recruiting
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen J. Yost
- Recruiting
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen J. Yost
- Recruiting
Central Care Cancer Center - Great Bend
Great Bend, Kansas, 67530
Site Public Contact, 913-948-5588, aroland@kccop.org
Jay W. Carlson
- Recruiting
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, 59405
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Great Falls Clinic
Great Falls, Montana, 59405
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Suspended
North Colorado Medical Center
Greeley, Colorado, 80631
- Recruiting
Dayton Physicians LLC-Wayne
Greenville, Ohio, 45331
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Wayne Hospital
Greenville, Ohio, 45331
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Mount Carmel Grove City Hospital
Grove City, Ohio, 43123
Site Public Contact, 877-779-7585, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
Zangmeister Center Grove City
Grove City, Ohio, 43123
Site Public Contact, 614-488-2745, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
Site Public Contact, 206-215-3086, PCRC-NCORP@Swedish.org
Charles W. Drescher
- Recruiting
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, 28546
Site Public Contact, 910-587-9084, jfields@cancersmoc.com
Samer S. Kasbari
- Recruiting
McFarland Clinic - Jefferson
Jefferson, Iowa, 50129
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Recruiting
Capital Region Southwest Campus
Jefferson City, Missouri, 65109
Site Public Contact, 573-632-4814, swooden@mail.crmc.org
Bryan A. Faller
- Recruiting
Freeman Health System
Joplin, Missouri, 64804
Site Public Contact, 417-347-4030, LJCrockett@freemanhealth.com
Jay W. Carlson
- Recruiting
Mercy Hospital Joplin
Joplin, Missouri, 64804
Site Public Contact, 417-556-3074, esmeralda.carrillo@mercy.net
Jay W. Carlson
- Recruiting
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen J. Yost
- Recruiting
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen J. Yost
- Recruiting
Ascension Borgess Cancer Center
Kalamazoo, Michigan, 49009
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen J. Yost
- Recruiting
Borgess Medical Center
Kalamazoo, Michigan, 49048
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen J. Yost
- Recruiting
Kalispell Regional Medical Center
Kalispell, Montana, 59901
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336
Site Public Contact, 509-783-4637, research@kadlecmed.org
Charles W. Drescher
- Recruiting
Greater Dayton Cancer Center
Kettering, Ohio, 45409
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- 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
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
Site Public Contact, 608-775-2385, cancerctr@gundersenhealth.org
David E. Marinier
- Recruiting
Providence Regional Cancer System-Lacey
Lacey, Washington, 98503
Site Public Contact, 360-412-8958, deidre.dillon@providence.org
Charles W. Drescher
- Active, not recruiting
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045
- Recruiting
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, 80228
Site Public Contact, 303-777-2663, info@westernstatesncorp.org
Nicholas DiBella
- Recruiting
Fairfield Medical Center
Lancaster, Ohio, 43130
Site Public Contact, 740-687-8863, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
Saint Rita's Medical Center
Lima, Ohio, 45801
Site Public Contact, 419-226-9617
Timothy D. Moore
- Recruiting
Cancer Partners of Nebraska - Pine Lake
Lincoln, Nebraska, 68516
Site Public Contact, 402-327-7363, research@cancerpartners.com
Joni A. Tilford
- Recruiting
Southeast Nebraska Cancer Center - 68th Street Place
Lincoln, Nebraska, 68516
Site Public Contact, 402-327-7363, research@cancerpartners.com
Joni A. Tilford
- Recruiting
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, 80120
Site Public Contact, 303-777-2663, info@westernstatesncorp.org
Nicholas DiBella
- Recruiting
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, 80124
Site Public Contact, 303-777-2663, info@westernstatesncorp.org
Nicholas DiBella
- Suspended
Sky Ridge Medical Center
Lone Tree, Colorado, 80124
- Recruiting
PeaceHealth Saint John Medical Center
Longview, Washington, 98632
Site Public Contact, 360-514-2016, kmakin-bond@peacehealth.org
Charles W. Drescher
- Recruiting
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
Site Public Contact, 888-798-0719
Bartosz Chmielowski
- Suspended
McKee Medical Center
Loveland, Colorado, 80539
- Recruiting
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
Site Public Contact, 800-622-8922
Vincent T. Ma
- Recruiting
OhioHealth Mansfield Hospital
Mansfield, Ohio, 44903
Site Public Contact, 419-526-8018, sheree@columbusccop.org
Timothy D. Moore
- 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
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109
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
Marietta Memorial Hospital
Marietta, Ohio, 45750
Site Public Contact, 800-523-3977, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
OhioHealth Marion General Hospital
Marion, Ohio, 43302
Site Public Contact, 614-488-2118, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
McFarland Clinic - Marshalltown
Marshalltown, Iowa, 50158
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Recruiting
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Chady A. Leon
- Recruiting
Contra Costa Regional Medical Center
Martinez, California, 94553-3156
Site Public Contact, 925-957-5400
Lisa Bailey
- Recruiting
Aspirus Medford Hospital
Medford, Wisconsin, 54451
Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org
Andrew J. Huang
- Recruiting
Idaho Urologic Institute-Meridian
Meridian, Idaho, 83642
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
John M. Schallenkamp
- Recruiting
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642
Site Public Contact, 208-381-2774, eslinget@slhs.org
Charles W. Drescher
- Active, not recruiting
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
- Active, not recruiting
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, 33176
- Recruiting
UH Seidman Cancer Center at Southwest General Hospital
Middleburg Heights, Ohio, 44130
Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org
Ankit Mangla
- Recruiting
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Health Partners Inc
Minneapolis, Minnesota, 55454
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, 54548
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Chady A. Leon
- Recruiting
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802
Site Public Contact, 406-327-3118, amy.hanneman@providence.org
Charles W. Drescher
- Recruiting
Community Medical Hospital
Missoula, Montana, 59804
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Mobile Infirmary Medical Center
Mobile, Alabama, 36607
Site Public Contact, 251-435-3942
Furhan Yunus
- Recruiting
Monticello Cancer Center
Monticello, Minnesota, 55362
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864
Site Public Contact, 618-242-4600
Jay W. Carlson
- Recruiting
Knox Community Hospital
Mount Vernon, Ohio, 43050
Site Public Contact, 740-393-9000, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen J. Yost
- Recruiting
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83686
Site Public Contact, 208-381-2774, eslinget@slhs.org
Charles W. Drescher
- Recruiting
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Providence Queen of The Valley
Napa, California, 94558
Site Public Contact, 707-521-3830
Charles W. Drescher
- Recruiting
Mount Carmel New Albany Surgical Hospital
New Albany, Ohio, 43054
Site Public Contact, 614-488-2745, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
New Ulm Medical Center
New Ulm, Minnesota, 56073
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Licking Memorial Hospital
Newark, Ohio, 43055
Site Public Contact, 740-348-4000, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
Newark Radiation Oncology
Newark, Ohio, 43055
Site Public Contact, 614-488-2118, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
Providence Newberg Medical Center
Newberg, Oregon, 97132
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Recruiting
Lakeland Hospital Niles
Niles, Michigan, 49120
Site Public Contact, 616-391-1230
Kathleen J. Yost
- Recruiting
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, 49444
Site Public Contact, 616-391-1230, connie.szczepanek@crcwm.org
Kathleen J. Yost
- Recruiting
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Suspended
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, 94609
- Recruiting
Bay Area Tumor Institute
Oakland, California, 94609
Site Public Contact, 510-465-2242, lradke@bati.org
Lisa Bailey
- Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu
Abdul Rafeh Naqash
- Recruiting
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120
Site Public Contact, 405-752-3402
Jay W. Carlson
- Recruiting
Saint Alphonsus Medical Center-Ontario
Ontario, Oregon, 97914
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Recruiting
Orlando Health Cancer Institute
Orlando, Florida, 32806
Site Public Contact, 321-841-7246, CancerClinicalTrials@orlandohealth.com
Sajeve S. Thomas
- Recruiting
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Mercy Health - Paducah Medical Oncology and Hematology
Paducah, Kentucky, 42003
Site Public Contact, 270-538-5632, BJWarner@mercy.com
Nicholas DiBella
- Recruiting
University Hospitals Parma Medical Center
Parma, Ohio, 44129
Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org
Ankit Mangla
- Recruiting
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Methodist Medical Center of Illinois
Peoria, Illinois, 61636
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Mercy Health Perrysburg Cancer Center
Perrysburg, Ohio, 43551
Site Public Contact, 614-488-2118, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
Illinois CancerCare-Peru
Peru, Illinois, 61354
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Valley Radiation Oncology
Peru, Illinois, 61354
Site Public Contact, 815-664-4141
Bryan A. Faller
- Recruiting
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232
Site Public Contact, 412-647-8073
Yana Najjar
- Active, not recruiting
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, 33324
- Recruiting
Jefferson Healthcare
Port Townsend, Washington, 98368
Site Public Contact, 360-344-3091
Nicholas DiBella
- Recruiting
Providence Portland Medical Center
Portland, Oregon, 97213
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Recruiting
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Recruiting
Southern Ohio Medical Center
Portsmouth, Ohio, 45662
Site Public Contact, 614-488-2118, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Fairview Northland Medical Center
Princeton, Minnesota, 55371
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
University Hospitals Portage Medical Center
Ravenna, Ohio, 44266
Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org
Ankit Mangla
- Recruiting
Saint Charles Health System-Redmond
Redmond, Oregon, 97756
Site Public Contact, 541-706-2909
Charles W. Drescher
- Recruiting
Spectrum Health Reed City Hospital
Reed City, Michigan, 49677
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen J. Yost
- Recruiting
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Chady A. Leon
- Recruiting
Reid Health
Richmond, Indiana, 47374
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, 65401
Site Public Contact, 573-458-7504, research@phelpshealth.org
Jay W. Carlson
- Recruiting
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401
Site Public Contact, 573-458-6379
Jay W. Carlson
- Recruiting
Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan, 49085
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen J. Yost
- Recruiting
Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen J. Yost
- Recruiting
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506
Site Public Contact, 816-271-7937, linda.schumacher@mymlc.com
Jay W. Carlson
- Recruiting
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Regions Hospital
Saint Paul, Minnesota, 55101
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
United Hospital
Saint Paul, Minnesota, 55102
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670
Site Public Contact, 314-996-5569
Bryan A. Faller
- Recruiting
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
Site Public Contact, 888-424-2100, cancerinfo@hci.utah.edu
Joanne M. Jeter
- Recruiting
Sharp Memorial Hospital
San Diego, California, 92123
Site Public Contact, 858-939-5062, cathy.wood@sharp.com
Charles H. Redfern
- Recruiting
Kootenai Cancer Clinic
Sandpoint, Idaho, 83864
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
UH Seidman Cancer Center at Firelands Regional Medical Center
Sandusky, Ohio, 44870
Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org
Ankit Mangla
- Recruiting
Providence Medical Foundation - Santa Rosa
Santa Rosa, California, 95403
Site Public Contact, 707-521-3830
Charles W. Drescher
- Recruiting
Providence Santa Rosa Memorial Hospital
Santa Rosa, California, 95405
Site Public Contact, 707-521-3830
Charles W. Drescher
- Active, not recruiting
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405
- Suspended
Pacific Gynecology Specialists
Seattle, Washington, 98104
- Recruiting
Swedish Medical Center-Ballard Campus
Seattle, Washington, 98107
Site Public Contact, 206-215-3086, PCRC-NCORP@Swedish.org
Charles W. Drescher
- Recruiting
Swedish Medical Center-Cherry Hill
Seattle, Washington, 98122-5711
Site Public Contact, 206-215-3086, PCRC-NCORP@Swedish.org
Charles W. Drescher
- Recruiting
Swedish Medical Center-First Hill
Seattle, Washington, 98122
Site Public Contact, 206-215-3086, PCRC-NCORP@Swedish.org
Charles W. Drescher
- Recruiting
PeaceHealth United General Medical Center
Sedro-Woolley, Washington, 98284
Site Public Contact, 360-788-8238, lkey@peacehealth.org
Charles W. Drescher
- Recruiting
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Providence Regional Cancer System-Shelton
Shelton, Washington, 98584
Site Public Contact, 360-412-8958, deidre.dillon@providence.org
Charles W. Drescher
- Recruiting
Welch Cancer Center
Sheridan, Wyoming, 82801
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Active, not recruiting
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
- Recruiting
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Site Public Contact, 217-545-7929
Bryan A. Faller
- Recruiting
Springfield Clinic
Springfield, Illinois, 62702
Site Public Contact, 800-444-7541
Bryan A. Faller
- Recruiting
Memorial Medical Center
Springfield, Illinois, 62781
Site Public Contact, 217-528-7541, pallante.beth@mhsil.com
Bryan A. Faller
- Recruiting
Mercy Hospital Springfield
Springfield, Missouri, 65804
Site Public Contact, 417-269-4520
Jay W. Carlson
- Recruiting
CoxHealth South Hospital
Springfield, Missouri, 65807
Site Public Contact, 417-269-4520
Jay W. Carlson
- Recruiting
Springfield Regional Cancer Center
Springfield, Ohio, 45504
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Timothy D. Moore
- Recruiting
Springfield Regional Medical Center
Springfield, Ohio, 45505
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Timothy D. Moore
- Recruiting
Saint Louis Cancer and Breast Institute-South City
St Louis, Missouri, 63109
Site Public Contact, 314-353-1870
Jay W. Carlson
- Recruiting
Mercy Hospital South
St Louis, Missouri, 63128
Site Public Contact, janet.lesko@mercy.net
Jay W. Carlson
- Recruiting
Missouri Baptist Medical Center
St Louis, Missouri, 63131
Site Public Contact, 314-996-5569
Bryan A. Faller
- Recruiting
Mercy Hospital Saint Louis
St Louis, Missouri, 63141
Site Public Contact, 314-251-7066
Jay W. Carlson
- Recruiting
Wake Forest Baptist Health - Hematology Oncology - Statesville
Statesville, North Carolina, 28677
Site Public Contact, 704-872-3630
Pierre L. Triozzi
- Recruiting
Ascension Saint Michael's Hospital
Stevens Point, Wisconsin, 54481
Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org
Andrew J. Huang
- Recruiting
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Chady A. Leon
- Recruiting
Lakeview Hospital
Stillwater, Minnesota, 55082
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080
Site Public Contact, 314-996-5569
Bryan A. Faller
- Recruiting
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri, 63127
Site Public Contact, 314-996-5569
Bryan A. Faller
- Suspended
Southwest Illinois Health Services LLP
Swansea, Illinois, 62226
- Recruiting
Moffitt Cancer Center-International Plaza
Tampa, Florida, 33607
Site Public Contact, 800-679-0775, ClinicalTrials@moffitt.org
Zeynep Eroglu
- Recruiting
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, 33612
Site Public Contact, 800-679-0775, ClinicalTrials@moffitt.org
Zeynep Eroglu
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Site Public Contact, 800-679-0775, ClinicalTrials@moffitt.org
Zeynep Eroglu
- Recruiting
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado, 80260
Site Public Contact, 303-777-2663, info@westernstatesncorp.org
Nicholas DiBella
- Recruiting
Saint Vincent Mercy Medical Center
Toledo, Ohio, 43608
Site Public Contact, 614-488-2118, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
Mercy Health - Saint Anne Hospital
Toledo, Ohio, 43623
Site Public Contact, 614-488-2118, sheree@columbusccop.org
Timothy D. Moore
About this study
Official title: A Randomized Phase 2 Trial of Encorafenib + Binimetinib + Nivolumab vs Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases
This phase II trial compares the effect of encorafenib, binimetinib, and nivolumab versus ipilimumab and nivolumab in treating patients with BRAF- V600 mutant melanoma that has spread to the brain (brain metastases). Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Ipilimumab and nivolumab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. This trial aims to find out which approach is more effective in shrinking and controlling brain metastases from melanoma.
Read the detailed description
PRIMARY OBJECTIVE:
- To compare progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 between participants randomized to the triplet combination of encorafenib + binimetinib + nivolumab versus the doublet combination of ipilimumab + nivolumab among participants with BRAF-V600 mutant melanoma that has metastasized to the brain.
SECONDARY OBJECTIVES:
- To estimate the overall survival (OS) of participants in each treatment arm. II. To estimate the objective response rate (ORR) (confirmed and unconfirmed, complete and partial responses) per RECIST 1.1 in each treatment arm.
III. To estimate the intracranial response rate (ICRR), defined as confirmed and unconfirmed complete and partial response per modified RECIST for brain metastases (mRECIST).
IV. To evaluate the duration of response, per RECIST 1.1 and the duration of ICRR per mRECIST, and per Response Assessment in Neuro-Oncology (RANO)-Brain Metastases (BM) (and immunotherapy [i]RANO) in each treatment arm.
- To evaluate the toxicity profile of each treatment arm. VI. To evaluate current and emerging radiographic response criteria (modified RECIST 1.1, modified RANO-BM and iRANO) by a retrospective blinded independent centralized review (BICR) of banked images.
BANKING OBJECTIVE:
- To bank tumor tissue, cerebral spinal fluid (CSF), stool and blood samples for future correlative studies.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive encorafenib orally (PO) once daily (QD) on days 1-28, binimetinib PO twice daily (BID) on days 1-28, and nivolumab intravenously (IV) on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive nivolumab IV on day 1 of all cycles and ipilimumab IV over 30 minutes on day 1 of cycles 1-4. Cycles repeat every 21 days for 4 cycles and then every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for 2 years, and then annually until 3 years after randomization.
- Conditions
- Acral Lentiginous Melanoma, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Cutaneous Melanoma, Metastatic Malignant Neoplasm in the Brain, Metastatic Melanoma, Metastatic Mucosal Melanoma
- Being tested
- Binimetinib, Encorafenib, Ipilimumab, Nivolumab
- Medical subject headings
- Melanoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BinimetinibDrug
Also called ARRY-162, ARRY-438162, MEK162, Mektovi
Given PO
EncorafenibDrug
Also called Braftovi, LGX 818, LGX-818, LGX818
Given PO
IpilimumabBiological
Also called Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS-734016, MDX-010, MDX-CTLA4
Given IV
NivolumabBiological
Also called BMS-936558, MDX-1106, NIVO, ONO-4538
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I (encorafenib, binimetinib, nivolumab) | Experimental | Patients receive encorafenib PO QD on days 1-28, binimetinib PO BID on days 1-28, and nivolumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Binimetinib; Drug: Encorafenib; Biological: Nivolumab |
| Arm II (nivolumab, ipilimumab) | Experimental | Patients receive nivolumab IV on day 1 of all cycles and ipilimumab IV over 30 minutes on day 1 of cycles 1-4. Cycles repeat every 21 days for 4 cycles and then every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Biological: Ipilimumab; Biological: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Measured: From date of registration to date of first documentation of progression, or symptomatic deterioration, or death due to any cause, assessed up to 3 years after randomization
Secondary outcomes (4)
Overall survival (OS)
Will be assessed by Immunotherapy Response Assessment Criteria for Intracranial Metastases (RANO-BM). Will construct Kaplan-Meier plots and estimate the median OS and construct 95% Brookmeyer-Crowley Confidence intervals.
Measured: From date of registration to date of death due to any cause, assessed up to 3 years after randomization
Intracranial response rate (ICRR)
The ICRR is defined as the best response when applying modified (m)RECIST criteria. Will compare intracranial response based on assessments per mRECIST, RANO-BM and immunotherapy (i)RANO criteria based on a review of the banked images. For each of these methods, the best response to treatment will be summarized by treatment arm, the percent agreement between each pair of methods will be reported along with a 95% confidence interval, and a p-value based on a two-sided McNemar's test will be calculated.
Measured: Up to 3 years after randomization
Objective response rate
Will be assessed by RECIST 1.1.
Measured: Up to 3 years after randomization
Duration of response
Measured: Up to 3 years after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start6 Jan 2021
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acral Lentiginous MelanomaStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Zeynep Eroglu, Principal investigator, SWOG Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511013
- Sponsor's protocol ID
- S2000
- Other IDs
- NCI-2020-05496, S2000, S2000, U10CA180888
- Status last verified
- Sep 2026
- First submitted
- 10 Aug 2020
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2 Trial of Encorafenib + Binimetinib + Nivolumab vs Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases
- ClinicalTrials.gov ID
- NCT04511013
- Acronym / sponsor ID
- S2000
- Conditions
- Acral Lentiginous Melanoma, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Cutaneous Melanoma, Metastatic Malignant Neoplasm in the Brain, Metastatic Melanoma, Metastatic Mucosal Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 12 Aug 2020 (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 phase II trial compares the effect of encorafenib, binimetinib, and nivolumab versus ipilimumab and nivolumab in treating patients with BRAF- V600 mutant melanoma that has spread to the brain (brain metastases). Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Ipilimumab and nivolumab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. This trial aims to find out which approach is more effective in shrinking and controlling brain metastases from melanoma.
Detailed description
PRIMARY OBJECTIVE:
- To compare progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 between participants randomized to the triplet combination of encorafenib + binimetinib + nivolumab versus the doublet combination of ipilimumab + nivolumab among participants with BRAF-V600 mutant melanoma that has metastasized to the brain.
SECONDARY OBJECTIVES:
- To estimate the overall survival (OS) of participants in each treatment arm. II. To estimate the objective response rate (ORR) (confirmed and unconfirmed, complete and partial responses) per RECIST 1.1 in each treatment arm.
III. To estimate the intracranial response rate (ICRR), defined as confirmed and unconfirmed complete and partial response per modified RECIST for brain metastases (mRECIST).
IV. To evaluate the duration of response, per RECIST 1.1 and the duration of ICRR per mRECIST, and per Response Assessment in Neuro-Oncology (RANO)-Brain Metastases (BM) (and immunotherapy [i]RANO) in each treatment arm.
- To evaluate the toxicity profile of each treatment arm. VI. To evaluate current and emerging radiographic response criteria (modified RECIST 1.1, modified RANO-BM and iRANO) by a retrospective blinded independent centralized review (BICR) of banked images.
BANKING OBJECTIVE:
- To bank tumor tissue, cerebral spinal fluid (CSF), stool and blood samples for future correlative studies.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive encorafenib orally (PO) once daily (QD) on days 1-28, binimetinib PO twice daily (BID) on days 1-28, and nivolumab intravenously (IV) on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive nivolumab IV on day 1 of all cycles and ipilimumab IV over 30 minutes on day 1 of cycles 1-4. Cycles repeat every 21 days for 4 cycles and then every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for 2 years, and then annually until 3 years after randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (encorafenib, binimetinib, nivolumab) | Experimental | Drug: Binimetinib, Drug: Encorafenib, Biological: NivolumabPatients receive encorafenib PO QD on days 1-28, binimetinib PO BID on days 1-28, and nivolumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Arm II (nivolumab, ipilimumab) | Experimental | Biological: Ipilimumab, Biological: NivolumabPatients receive nivolumab IV on day 1 of all cycles and ipilimumab IV over 30 minutes on day 1 of cycles 1-4. Cycles repeat every 21 days for 4 cycles and then every 28 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Participants must have histologically and pathologically confirmed melanoma that has metastasized to the brain
- Any primary (cutaneous, acral/mucosal, etc) or unknown origin are permitted, except that participants with uveal primary are not eligible
- Participants must have BRAF-V600 mutant melanoma documented by a Clinical Laboratory Improvement Act (CLIA)-certified laboratory
- All participants must have an magnetic resonance imaging (MRI) of the brain within 28 days prior to registration and must have central nervous system metastases with at least one measurable brain metastasis >= 0.5 cm in size (per modified RECIST 1.1) that has not been irradiated, or progressed (in the opinion of the treating physician) after prior radiation therapy. Participating sites MUST use MRI slice thickness of =< 1.5 mm and are recommended to adhere to the 'minimum' Brain Tumor Imaging Protocol for Clinical Trials in Brain Metastases (BTIP-BM) compliant MRI acquisition protocol. Computed tomography (CT) of the head cannot substitute for brain MRI. (NOTE: All central nervous system [CNS] disease must be documented on BOTH the Brain Metastases Baseline Tumor Assessment Form, using modified RECIST, and the Baseline Tumor Assessment Form [RECIST 1.1] using RECIST 1.1.)
- Participants may have measurable or non-measurable extracranial disease. All measurable disease must be assessed within 28 days prior to randomization; all non-measurable disease must be assessed within 42 days prior to randomization. Please note, while any extracranial disease will also be assessed and followed, participants are NOT required to have extracranial disease for randomization. NOTE: All disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1). CNS disease must be documented on BOTH the Brain Metastases Baseline Tumor Assessment Form, using modified RECIST, and the Baseline Tumor Assessment Form (RECIST 1.1) using RECIST 1.1
Key exclusion criteria (9 listed)
- Participants must not have received prior systemic therapy for metastatic disease. Prior systemic therapy received only in the neoadjuvant and/or adjuvant setting (e.g., BRAF/MEK inhibitor therapy, anti-PD-1 therapy or anti-CTLA4 therapy, alfa-interferon, etc.) is permitted. If patients received prior neoadjuvant/adjuvant therapy, they must have had eventual disease relapse prior to randomization
- Participants must not have had prior radiation therapy within 7 days prior to randomization
- Participants must not be planning to require any additional form of systemic anti-tumor therapy for melanoma while on protocol treatment
- Participants must not be planning to use hormonal contraceptives
- Participants must not have a serious active infection requiring systemic therapy at time of randomization in the opinion of the treating physician
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 |
|---|---|---|
| BinimetinibAlso: ARRY-162, ARRY-438162, MEK162, MektoviGiven PO | Drug | Arm I (encorafenib, binimetinib, nivolumab) |
| EncorafenibAlso: Braftovi, LGX 818, LGX-818, LGX818Given PO | Drug | Arm I (encorafenib, binimetinib, nivolumab) |
| IpilimumabAlso: Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS-734016, MDX-010, MDX-CTLA4Given IV | Biological | Arm II (nivolumab, ipilimumab) |
| NivolumabAlso: BMS-936558, MDX-1106, NIVO, ONO-4538Given IV | Biological | Arm I (encorafenib, binimetinib, nivolumab), Arm II (nivolumab, ipilimumab) |
Primary outcome
Progression-free survival
Time frame: From date of registration to date of first documentation of progression, or symptomatic deterioration, or death due to any cause, assessed up to 3 years after randomization
Will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
4 secondary outcomes
Overall survival (OS)
Time frame: From date of registration to date of death due to any cause, assessed up to 3 years after randomization
Intracranial response rate (ICRR)
Time frame: Up to 3 years after randomization
Objective response rate
Time frame: Up to 3 years after randomization
Duration of response
Time frame: Up to 3 years after randomization
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 15 Sep 2026.
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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.
Zeynep Eroglu principal investigator
SWOG Cancer Research Network
331 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Binimetinib, Encorafenib and Ipilimumab in people with Acral Lentiginous Melanoma and Clinical Stage IV Cutaneous Melanoma AJCC v8, run by SWOG Cancer Research Network at 331 sites in United States.
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 24 inclusion and 9 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 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 331 sites in United States. 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?
Contact Catrina Mireles (2106148808 ext. 1014, cmireles@swog.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: From date of registration to date of first documentation of progression, or symptomatic deterioration, or death due to any cause, assessed up to 3 years after randomization). 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 15 Sep 2026.