Clear Cell Renal Cell CarcinomaPhase 3STRIKENCT06661720
Testing the Addition of the Anti-Cancer Drug Tivozanib to Immunotherapy (Pembrolizumab) After Surgery to Remove All Known Sites of Kidney Cancer
A Phase 3 study testing Pembrolizumab, Tivozanib and Biospecimen Collection in people with Clear Cell Renal Cell Carcinoma and Renal Cell Carcinoma (RCC), run by Alliance for Clinical Trials in Oncology at 429 sites in United States.
Trial summary
This phase III trial compares the effect of adding tivozanib to standard therapy pembrolizumab versus pembrolizumab alone for the treatment of patients with high-risk renal cell carcinoma (RCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clear Cell Renal Cell Carcinoma, Renal Cell Carcinoma (RCC), Stage II Renal Pelvis Cancer AJCC v8
- What is being tested?
- Pembrolizumab, Tivozanib and Biospecimen Collection
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,040 participants
- Where
- 429 sitesUnited States
- Study dates
- 14 Mar 2025to Nov 2037
- Phase
- Phase 3
- 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
- • Histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features following complete resection of the primary tumor (radical or partial nephrectomy)
- Note: Patients with microscopically positive soft tissue or vascular margins without gross residual disease are permitted
- Intermediate-high risk RCC:
- pT2 grade 4 or sarcomatoid features, N0M0
- pT3 any grade N0, M0
- High-risk RCC
Show all 49Show fewer
- pT4, any grade, N0, M0
- pT, any stage., any grade, N+, M0
- cM1 no evidence of disease (NED) RCC
- Participants who have had resection of primary tumor (radical or partial nephrectomy) and resection or definitive radiation or ablation of solid, isolated, soft tissue metastases (excluding brain and bone lesions) at the time of primary tumor removal (synchronous) or ≤1 year from primary tumor removal (metachronous)
- Surgery (radical or partial nephrectomy or metastasectomy or ablation) > 4 weeks but =< 16 weeks prior to study registration with no ongoing complications from surgery
- No evidence of disease at time of randomization as assessed by investigator by either CT or MRI scan of the brain and chest, abdomen and pelvis
- No prior systemic treatment for RCC
- Age >= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (or Karnofsky >= 60%)
- Absolute neutrophil count (ANC) >= 1,000/mm^3
- Platelet count >= 100,000/mm^3
- Hemoglobin >= 8 g/dL
- Total bilirubin =< 3 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x upper limit of normal (ULN)
- Calculated (calc.) creatinine clearance >= 30 mL/min (using Cockcroft Gault equation or the estimated glomerular filtration rate from the modification of diet in renal disease trial)
- Urine protein =< 1+ on urine analysis (UA) or urine protein creatinine ration (UPCR) < 2mg/mg
- Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test is required =< 14 days prior to registration
- HIV status: HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- Hepatitis
- Hepatitis B: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with resolved HBV infection, defined as positive hepatitis B core antibody (anti-HBc) and negative hepatitis B surface antigen (HbsAg), are eligible
- Hepatitis C: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- Cardiac Disease: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class IIB or better
- No history of myocarditis
- No history of clinically significant pneumonitis
- No uncontrolled hypertension (systolic blood pressure [BP] > 150 mm Hg or diastolic BP > 90 mm Hg) documented on 2 consecutive measurements taken at least 2 hours apart
- No serious non-healing wound, ulcer or bone fracture within 28 days prior to registration
- No serious/active infection requiring parenteral antibiotics
- No moderate or severe hepatic impairment (child-Pugh B or C)
- No significant bleeding disorders within 1 month prior to registration, for example:
- Hematemesis, hematochezia or other gastrointestinal bleeding grade 3 or higher
- Hemoptysis of pulmonary bleeding grade 3 or higher
- Hematuria or other genitourinary bleeding grade 3 or higher
- No history of allogeneic organ transplantation
- No history of allergy of hypersensitivity to study drugs or components
- No condition requiring systemic treatment with either corticosteroid (> 10 mg daily or prednisone equivalent) within 14 days of treatment initiation or other immunosuppressive medications within 30 days of randomization. Inhaled or topical steroids and adrenal replacement doses ≤10 mg daily prednisone equivalent are permitted in absence of active autoimmune disease
- No active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis or other gastrointestinal condition associated with increased risk of perforation; history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 4 weeks prior to registration
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- No patients with a history of autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids > 10 mg/day, or immunosuppressive drugs) with the following exceptions:
- Replacement therapy (e.g., thyroxine, insulin, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
- Brief (<7 days) use of systemic corticosteroids is allowed when use is considered standard of care
- Patients with vitiligo, psoriasis, type 1 diabetes mellitus, hypothyroidism, or resolved childhood asthma/atopy will not be excluded
- Patients requiring intermittent use of bronchodilators, inhaled steroids, or local steroid injections will not be excluded
- Patients with hypothyroidism that is stable with hormone replacement or Sjögren's syndrome will not be excluded • Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment
Who cannot join
None listed.
Trial locations and contacts
429 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, 283 recruiting
- Recruiting
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu
Amy C. Tarnower
- Recruiting
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Houssam Y. Hariri
- Recruiting
UPMC Altoona
Altoona, Pennsylvania, 16601
Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org
Leonard J. Appleman
- Recruiting
The Don and Sybil Harrington Cancer Center
Amarillo, Texas, 79106
Site Public Contact, 806-212-1985, Gina.Cravey@bsahs.org
Anita Ravipati
- 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
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
Site Public Contact, 920-364-3604, ResearchDept@thedacare.org
Joyce Philip
- Recruiting
AdventHealth Infusion Center Asheville
Asheville, North Carolina, 28803
Site Public Contact, 828-650-8037, AMBER.WHEELER@AdventHealth.com
Jennifer L. Heaberlin
- Recruiting
Duluth Clinic Ashland
Ashland, Wisconsin, 54806
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Grady Health System
Atlanta, Georgia, 30303
Site Public Contact, 404-778-1868
Viraj Master
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Site Public Contact, 888-946-7447
Viraj Master
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Site Public Contact, 404-778-1868
Viraj Master
- Recruiting
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Site Public Contact, 404-851-7115
Viraj Master
- Recruiting
Sutter Auburn Faith Hospital
Auburn, California, 95602
Site Public Contact, clinicalresearch@sutterhealth.org
Uma Suryadevara
- Recruiting
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045
Site Public Contact, 720-848-0650
Corbin Eule
- Suspended
Rush-Copley Medical Center
Aurora, Illinois, 60504
- Recruiting
Advocate Outpatient Center - Aurora
Aurora, Illinois, 60506
Site Public Contact, ncorp@aah.org
Adam P. Siegel
- Recruiting
Hartford HealthCare - Avon
Avon, Connecticut, 06001
Site Public Contact, 860-972-4700
Michael Sun
- Suspended
IU Health West Hospital
Avon, Indiana, 46123
- Recruiting
UH Seidman Cancer Center at UH Avon Health Center
Avon, Ohio, 44011
Site Public Contact, 800-641-2422
Shahla Bari
- Recruiting
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri, 63011
Site Public Contact, 888-446-3729
Jay W. Carlson
- Recruiting
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
Site Public Contact, 800-888-8823
Arif Hussain
- Recruiting
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010
Site Public Contact, 847-842-4847
Adam P. Siegel
- Recruiting
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Site Public Contact, 212-639-7592
Darren R. Feldman
- Recruiting
Bronson Battle Creek
Battle Creek, Michigan, 49017
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Houston Methodist San Jacinto Hospital
Baytown, Texas, 77521
Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org
Patrick E. Prath
- Recruiting
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122
Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org
Shahla Bari
- Recruiting
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania, 15009
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Leonard J. Appleman
- Suspended
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431
- Recruiting
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Site Public Contact, 218-333-5000, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602
Site Public Contact, 802-225-5400
Rahul Anil
- Recruiting
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Houssam Y. Hariri
- Recruiting
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa, 52722
Site Public Contact, 563-355-7733, katherine-daprile@uiowa.edu
Fernando Maciel Barbosa
- Recruiting
Beverly Hospital
Beverly, Massachusetts, 01915
Site Public Contact, 978-922-3000 ext. 2405
Julio Hajdenberg
- Recruiting
Tower Cancer Research Foundation
Beverly Hills, California, 90211
Site Public Contact, towercancerresearch@toweroncology.com
Edwin M. Posadas
- Recruiting
Billings Clinic Cancer Center
Billings, Montana, 59101
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- 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 Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Site Public Contact, 208-381-2774, eslinget@slhs.org
Alison K. Conlin
- Suspended
McFarland Clinic - Boone
Boone, Iowa, 50036
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Site Public Contact, 617-636-5000, ContactUsCancerCenter@TuftsMedicalCenter.org
Paul Mathew
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Site Public Contact, 877-442-3324
Bradley A. McGregor
- Recruiting
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Lafayette Family Cancer Center-EMMC
Brewer, Maine, 04412
Site Public Contact, 800-987-3005
Sarah J. Sinclair
- Recruiting
Hartford HealthCare - Saint Vincent's Medical Center
Bridgeport, Connecticut, 06606
Site Public Contact, 860-972-4700
Michael Sun
- Recruiting
United Hospital Center
Bridgeport, West Virginia, 26330
Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu
Joanna A. Kolodney
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Houssam Y. Hariri
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Site Public Contact, 800-767-9355, askroswell@roswellpark.org
Saby George
- Recruiting
Lahey Clinic
Burlington, Massachusetts, 01805
Site Public Contact, 781-744-3421, lhmc-cancer-clinical-trials@lahey.org
Julio Hajdenberg
- Recruiting
University of Vermont Medical Center
Burlington, Vermont, 05401
Site Public Contact, 802-656-4101, rpo@uvm.edu
Rahul Anil
- Recruiting
University of Vermont and State Agricultural College
Burlington, Vermont, 05405
Site Public Contact, 802-656-8990, rpo@uvm.edu
Rahul Anil
- Recruiting
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105
Site Public Contact, 414-302-2304, ncorp@aurora.org
Adam P. Siegel
- Recruiting
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
UPMC Hillman Cancer Center at Butler Health System
Butler, Pennsylvania, 16001
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Leonard J. Appleman
- Recruiting
Hematology Oncology Associates of CNY at Camillus
Camillus, New York, 13031
Site Public Contact, 315-472-7504
Steven M. Duffy
- 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
Houssam Y. Hariri
- Recruiting
Aultman Health Foundation
Canton, Ohio, 44710
Site Public Contact, 330-363-7274, ClinicalReserachDept@aultman.com
Aarthi Rajkumar
- Recruiting
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Site Public Contact, 573-334-2230, sfmc@sfmc.net
Bryan A. Faller
- Suspended
IU Health North Hospital
Carmel, Indiana, 46032
- 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
Duke Cancer Center Cary
Cary, North Carolina, 27518
Site Public Contact, NCTNStudyTeam@dm.duke.edu
Daniel J. George
- Recruiting
Waverly Hematology Oncology
Cary, North Carolina, 27518
Site Public Contact, 919-350-1700, TCHILDRESS@wakemed.org
Vijay Chaudhary
- 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
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Site Public Contact, 877-668-0683, cancerclinicaltrials@med.unc.edu
Tracy L. Rose
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu
Thai H. Ho
- Recruiting
Vandalia Health/CAMC Institute for Academic Medicine
Charleston, West Virginia, 25304
Site Public Contact, 304-388-9944, CAMCClinicalTrials@vandaliahealth.org
Kok Hoe Chan
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Houssam Y. Hariri
- Recruiting
Jefferson Cherry Hill Hospital
Cherry Hill, New Jersey, 08002
Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu
Patrick Mille
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Site Public Contact, 312-695-1301, cancer@northwestern.edu
David VanderWeele
- Recruiting
Rush MD Anderson Cancer Center
Chicago, Illinois, 60612
Site Public Contact, 312-226-2371, Cancer_Studies@rush.edu
Manan Shah
- Recruiting
University of Illinois
Chicago, Illinois, 60612
Site Public Contact, 312-355-3046
Karine Tawagi
- Recruiting
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
Site Public Contact, 773-296-5360
Adam P. Siegel
- Recruiting
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Melissa A. Reimers
- Recruiting
Case Western Reserve University
Cleveland, Ohio, 44106
Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org
Shahla Bari
- Recruiting
AdventHealth Infusion Center Haywood
Clyde, North Carolina, 28721
Site Public Contact, 828-650-8037, AMBER.WHEELER@AdventHealth.com
Jennifer L. Heaberlin
- 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
Osarenren Ogbeide
- Recruiting
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909
Site Public Contact, 719-365-2406
Corbin Eule
- Recruiting
Memorial Hospital North
Colorado Springs, Colorado, 80920
Site Public Contact, 719-364-6700
Corbin Eule
- Recruiting
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, 39705
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Osarenren Ogbeide
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Site Public Contact, 800-293-5066, Jamesline@osumc.edu
Eric A. Singer
- Recruiting
Memorial Sloan Kettering Commack
Commack, New York, 11725
Site Public Contact, 212-639-7592
Darren R. Feldman
- Recruiting
Mercy Hospital
Coon Rapids, Minnesota, 55433
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Melissa A. Reimers
- Recruiting
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, 60014
Site Public Contact, 630-929-6129, advocateresearch@advocate.com
Adam P. Siegel
- Recruiting
Aurora Saint Luke's South Shore
Cudahy, Wisconsin, 53110
Site Public Contact, 414-302-2304, ncorp@aurora.org
Adam P. Siegel
- Recruiting
UPMC Western Maryland
Cumberland, Maryland, 21502
Site Public Contact, 240-964-1400
Leonard J. Appleman
- Recruiting
Houston Methodist Cypress Hospital
Cypress, Texas, 77429
Site Public Contact, 346-356-1413, irb@houstonmethodist.org
Patrick E. Prath
- Recruiting
Parkland Memorial Hospital
Dallas, Texas, 75235
Site Public Contact, 214-590-5582, canceranswerline@UTSouthwestern.edu
Qian Qin
- Recruiting
UT Southwestern Simmons Cancer Center - RedBird
Dallas, Texas, 75237
Site Public Contact, 214-648-7097, canceranswerline@utsouthwestern.edu
Qian Qin
- Recruiting
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu
Qian Qin
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
Site Public Contact, 800-446-5532, Research@Carle.com
Suparna Mantha
- Recruiting
Geisinger Medical Center
Danville, Pennsylvania, 17822
Site Public Contact, 570-271-5251, cancerresearch@geisinger.edu
Sorab Gupta
- Recruiting
Miami Valley Hospital
Dayton, Ohio, 45409
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Miami Valley Hospital North
Dayton, Ohio, 45415
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- 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
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
David VanderWeele
- Recruiting
UCHealth - Cherry Creek
Denver, Colorado, 80206
Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org
Corbin Eule
- Recruiting
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, 06418
Site Public Contact, 203-785-5702, canceranswers@yale.edu
David A. Braun
- Recruiting
Geisinger Cancer Center Dickson City
Dickson City, Pennsylvania, 18519
Site Public Contact, 877-204-6081, cancerresearch@geisinger.edu
Sorab Gupta
- 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
Adam P. Siegel
- Recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Site Public Contact, 800-826-4673, becomingapatient@coh.org
Wesley Yip
- Recruiting
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Suspended
Duke University Medical Center
Durham, North Carolina, 27710
- Recruiting
Duke Cancer Center Southpoint
Durham, North Carolina, 27713
Site Public Contact, NCTNStudyTeam@dm.duke.edu
Daniel J. George
- 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
Houssam Y. Hariri
- Recruiting
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, 13057
Site Public Contact, 315-472-7504
Steven M. Duffy
- Recruiting
Fairview Southdale Hospital
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Minnesota Oncology - Edina
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Site Public Contact, 800-446-5532, Research@carle.com
Suparna Mantha
- 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
Adam P. Siegel
- Recruiting
Elmhurst Memorial Hospital
Elmhurst, Illinois, 60126
Site Public Contact, 630-758-5460, Jrohde@emhc.org
Matthew Siegel
- Recruiting
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, 16505
Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu
Leonard J. Appleman
- Recruiting
OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan, 49829
Site Public Contact, 920-433-8889, WI_research_admin@hshs.org
Anthony J. Jaslowski
- Recruiting
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Hartford Healthcare - Fairfield
Fairfield, Connecticut, 06824
Site Public Contact, 860-972-4700, CancerResearchSupport@hhchealth.org
Michael Sun
- Recruiting
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, 06824
Site Public Contact, 203-785-5702, canceranswers@yale.edu
David A. Braun
- Recruiting
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, 58103
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- 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
- Recruiting
Cancer Hematology Centers - Flint
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Houssam Y. Hariri
- 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
Houssam Y. Hariri
- Recruiting
Poudre Valley Hospital
Fort Collins, Colorado, 80524
Site Public Contact, 970-297-6150
Corbin Eule
- Recruiting
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, 80528
Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org
Corbin Eule
- Recruiting
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Recruiting
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas, 76104
Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu
Qian Qin
- Recruiting
Dana-Farber Cancer Institute at Foxborough
Foxborough, Massachusetts, 02035
Site Public Contact, 877-338-7425
Daniel Roberts
- Recruiting
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
Site Public Contact, 208-381-2774, eslinget@slhs.org
Alison K. Conlin
- Recruiting
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341
Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org
Michael Humeniuk
- Recruiting
UF Health Cancer Institute - Gainesville
Gainesville, Florida, 32610
Site Public Contact, 352-273-8010, cancer-center@ufl.edu
Daniel V. Araujo
- 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
David VanderWeele
- Recruiting
Tidelands Georgetown Memorial Hospital
Georgetown, South Carolina, 29440
Site Public Contact, 843-545-5600, broe@tidelandshealth.org
Thai H. Ho
- Recruiting
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022
Site Public Contact, 414-302-2304, ncorp@aurora.org
Adam P. Siegel
- Suspended
Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut, 06033
- Recruiting
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland, 21061
Site Public Contact, 410-553-8100
Arif Hussain
- Recruiting
Glens Falls Hospital
Glens Falls, New York, 12801
Site Public Contact, 518-926-6700
Rahul Anil
- Recruiting
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, 60026
Site Public Contact, 312-695-1102
David VanderWeele
- Recruiting
Addison Gilbert Hospital
Gloucester, Massachusetts, 01930
Site Public Contact, 978-283-4000 ext. 559
Julio Hajdenberg
- Recruiting
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024
Site Public Contact, 414-302-2304, ncorp@aurora.org
Adam P. Siegel
- 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
- Suspended
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
- Recruiting
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, 60030
Site Public Contact, 312-695-1102
David VanderWeele
- 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, 773-702-9171, protocols@AllianceNCTN.org
Corbin Eule
- Recruiting
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
Site Public Contact, 920-433-8889, WI_research_admin@hshs.org
Anthony J. Jaslowski
- 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
Anthony J. Jaslowski
- Recruiting
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311
Site Public Contact, 414-302-2304, ncorp@aurora.org
Adam P. Siegel
- Recruiting
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, 15601
Site Public Contact, 724-838-1900
Leonard J. Appleman
- Recruiting
Miami Valley Cancer Care and Infusion
Greenville, Ohio, 45331
Site Public Contact, 937-569-7515
Tarek M. Sabagh
- 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
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Recruiting
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, 06830
Site Public Contact, 203-785-5702, canceranswers@yale.edu
David A. Braun
- Recruiting
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Recruiting
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651
Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org
Michael Humeniuk
- Recruiting
Baptist Cancer Center-Grenada
Grenada, Mississippi, 38901
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Osarenren Ogbeide
- Recruiting
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, 06437
Site Public Contact, 203-785-5702, canceranswers@yale.edu
David A. Braun
- Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Site Public Contact, 551-996-2897
Robert S. Alter
- Suspended
The Cancer Institute of New Jersey Hamilton
Hamilton, New Jersey, 08690
- Recruiting
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, 17109
Site Public Contact, 717-724-6765, klitchfield@PINNACLEHEALTH.org
Leonard J. Appleman
- Recruiting
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Site Public Contact, 212-639-7592
Darren R. Feldman
- Recruiting
Hartford Hospital
Hartford, Connecticut, 06102
Site Public Contact, 860-545-5363
Michael Sun
- Suspended
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105
- Recruiting
Advocate South Suburban Hospital
Hazel Crest, Illinois, 60429
Site Public Contact, 708-799-9995
Adam P. Siegel
- Recruiting
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, 18201
Site Public Contact, 570-459-2901, cancerresearch@geisinger.edu
Sorab Gupta
- Recruiting
Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania, 18201
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Houssam Y. Hariri
- Recruiting
AdventHealth Hendersonville
Hendersonville, North Carolina, 28792
Site Public Contact, 828-650-8196, elizabeth.heier@AdventHealth.com
Jennifer L. Heaberlin
- Recruiting
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
Site Public Contact, 218-786-3308
Bret E. Friday
- Recruiting
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado, 80129
Site Public Contact, 720-848-0650
Corbin Eule
- Recruiting
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
Site Public Contact, 713-798-1354, burton@bcm.edu
Aihua E. Yen
- Recruiting
Ben Taub General Hospital
Houston, Texas, 77030
Site Public Contact, 713-873-2000
Aihua E. Yen
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Site Public Contact, 713-790-2700
Patrick E. Prath
- Recruiting
Methodist Willowbrook Hospital
Houston, Texas, 77070
Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org
Patrick E. Prath
- Recruiting
Houston Methodist West Hospital
Houston, Texas, 77094
Site Public Contact, 832-522-2873
Patrick E. Prath
- Recruiting
IRMC Cancer Center
Indiana, Pennsylvania, 15701
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Leonard J. Appleman
- Suspended
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
- Recruiting
Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, 46202
Site Public Contact, 317-278-5632, iutrials@iu.edu
Jennifer King
- Recruiting
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Site Public Contact, 800-237-1225
Fernando Maciel Barbosa
- Recruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612
Site Public Contact, 877-827-8839, ucstudy@uci.edu
Nataliya Mar
- Recruiting
City of Hope at Irvine Lennar
Irvine, California, 92618
Site Public Contact, 877-467-3411
Wesley Yip
- Recruiting
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Site Public Contact, 601-815-6700
John C. Henegan
- Suspended
McFarland Clinic - Jefferson
Jefferson, Iowa, 50129
- Recruiting
Emory Johns Creek Hospital
Johns Creek, Georgia, 30097
Site Public Contact, 404-778-5714, m.lisa.hwang@emory.edu
Viraj Master
- Recruiting
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania, 15901
Site Public Contact, 814-534-4724
Leonard J. Appleman
- Recruiting
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, 72401
Site Public Contact, 870-936-7066, Emily.Carvell@bmhcc.org
Osarenren Ogbeide
- 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
- 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
Adam P. Siegel
- 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
Michael O. Ojelabi
- Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Site Public Contact, 858-822-5354, cancercto@ucsd.edu
Rana R. McKay
- Recruiting
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045
Site Public Contact, cancertrials@northwestern.edu
David VanderWeele
- Recruiting
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042
Site Public Contact, 516-734-8896
Xinhua Zhu
- Recruiting
City of Hope Antelope Valley
Lancaster, California, 93534
Site Public Contact, 800-826-4673, becomingapatient@coh.org
Wesley Yip
- Recruiting
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912
Site Public Contact, 517-364-3712, harsha.trivedi@umhsparrow.org
Houssam Y. Hariri
- Recruiting
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma, 73505
Site Public Contact, 877-231-4440
Adanma Anji Ayanambakkam Attanathi
- Recruiting
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
Site Public Contact, 800-639-6918, cancer.research.nurse@dartmouth.edu
Jacob B. Reibel
- Recruiting
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837
Site Public Contact, 570-523-9200, cancerresearch@geisinger.edu
Sorab Gupta
- Recruiting
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
Site Public Contact, 859-257-3379
Insija Ilyas Selene
- Recruiting
AMG Libertyville - Oncology
Libertyville, Illinois, 60048
Site Public Contact, 630-929-6129, advocateresearch@advocatehealth.com
Adam P. Siegel
- Recruiting
Condell Memorial Hospital
Libertyville, Illinois, 60048
Site Public Contact, 630-929-6129, advocateresearch@advocatehealth.com
Adam P. Siegel
- Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Site Public Contact, 501-686-8274
Anuradha Kunthur
- Recruiting
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Houssam Y. Hariri
- Recruiting
UCHealth Lone Tree Health Center
Lone Tree, Colorado, 80124
Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org
Corbin Eule
- Recruiting
Monmouth Medical Center
Long Branch, New Jersey, 07740
Site Public Contact, 732-923-6564, mary.danish@rwjbh.org
Biren Saraiya
- Recruiting
Los Angeles General Medical Center
Los Angeles, California, 90033
Site Public Contact, 323-865-0451, uscnorrisinfo@med.usc.edu
Varsha Tulpule
- Recruiting
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Site Public Contact, 323-865-0451
Varsha Tulpule
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Site Public Contact, 310-423-2133, Cancer.trial.info@cshs.org
Edwin M. Posadas
- Recruiting
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
Site Public Contact, 888-798-0719
Brian Shuch
- Recruiting
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202
Site Public Contact, 502-562-3429
Rohit Kumar
- Recruiting
Baptist Health Louisville
Louisville, Kentucky, 40207
Site Public Contact, 502-897-8592, Cbcresearch@bhsi.com
Vikas K. Singh
- Recruiting
UofL Health Medical Center Northeast
Louisville, Kentucky, 40245
Site Public Contact, 502-852-2755, ctoinfo@louisville.edu
Rohit Kumar
- Recruiting
Medical Center of the Rockies
Loveland, Colorado, 80538
Site Public Contact, 970-203-7083
Corbin Eule
- 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 - Eastpark Medical Center
Madison, Wisconsin, 53718
Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu
Amy K. Taylor
- Recruiting
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu
Amy K. Taylor
- Recruiting
Hartford HealthCare - Manchester
Manchester, Connecticut, 06042
Site Public Contact, 860-972-4700
Michael Sun
- Recruiting
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143
Site Public Contact, 414-302-2304, ncorp@aurora.org
Adam P. Siegel
- Recruiting
McFarland Clinic - Marshalltown
Marshalltown, Iowa, 50158
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Recruiting
WVUH-Berkely Medical Center
Martinsburg, West Virginia, 25401
Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu
Joanna A. Kolodney
- Recruiting
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Site Public Contact, 800-446-5532, Research@carle.com
Suparna Mantha
- Recruiting
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania, 17050
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Leonard J. Appleman
- Recruiting
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia, 23116
Site Public Contact, 804-893-8978, anne_carmellat@bshsi.org
Joseph D. Pennington
- Recruiting
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Osarenren Ogbeide
- Recruiting
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051
Site Public Contact, 262-257-5100
Kathryn A. Bylow
- Recruiting
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, 44060
Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org
Shahla Bari
- Recruiting
Midstate Medical Center
Meriden, Connecticut, 06451
Site Public Contact, 866-662-5678
Michael Sun
- Recruiting
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642
Site Public Contact, 208-381-2774, eslinget@slhs.org
Alison K. Conlin
- Recruiting
Dana Farber-Merrimack Valley
Methuen, Massachusetts, 01844
Site Public Contact, 877-338-7425
Pedro M. Sanz-Altamira
- Recruiting
Miami Cancer Institute
Miami, Florida, 33176
Site Public Contact, 786-596-2000
Rohan Garje
- Recruiting
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Site Public Contact, 212-639-7592
Darren R. Feldman
- Recruiting
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, 23114
Site Public Contact, 804-893-8978, anne_carmellat@bshsi.org
Joseph D. Pennington
- Recruiting
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
Milford, Massachusetts, 01757
Site Public Contact, 877-332-4294
Daniel E. Fein
- Recruiting
Beebe South Coastal Health Campus
Millville, Delaware, 19967
Site Public Contact, 302-291-6730, research@beebehealthcare.org
Gregory A. Masters
- Recruiting
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, 53209
Site Public Contact, 414-302-2304, ncorp@aurora.org
Adam P. Siegel
- Recruiting
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
Site Public Contact, 414-302-2304, ncorp@aurora.org
Adam P. Siegel
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Site Public Contact, 414-805-3666
Kathryn A. Bylow
- Recruiting
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233
Site Public Contact, 414-302-2304, ncorp@aurora.org
Adam P. Siegel
- Recruiting
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Minneapolis VA Medical Center
Minneapolis, Minnesota, 55417
Site Public Contact, 612-467-2800
Nivedita Arora
- Recruiting
Community Medical Center
Missoula, Montana, 59804
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Memorial Medical Center
Modesto, California, 95355
Site Public Contact, clinicalresearch@sutterhealth.org
Uma Suryadevara
- Recruiting
Trinity Medical Center
Moline, Illinois, 61265
Site Public Contact, 309-779-2000
Suparna Mantha
- Recruiting
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania, 15146
Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu
Leonard J. Appleman
- Recruiting
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Site Public Contact, 212-639-7592
Darren R. Feldman
- Recruiting
West Virginia University Healthcare
Morgantown, West Virginia, 26506
Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu
Joanna A. Kolodney
- Active, not recruiting
Morristown Medical Center
Morristown, New Jersey, 07960
- Recruiting
Northern Westchester Hospital
Mount Kisco, New York, 10549
Site Public Contact, 914-666-1366, AMellor@northwell.edu
Xinhua Zhu
- Recruiting
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149
Site Public Contact, research.institute@phci.org
Timothy R. Wassenaar
- Suspended
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444
- Recruiting
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83687
Site Public Contact, 208-381-2774, eslinget@slhs.org
Alison K. Conlin
- Recruiting
Edward Hospital/Cancer Center
Naperville, Illinois, 60540
Site Public Contact, 630-646-6075
Matthew Siegel
- Recruiting
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Site Public Contact, 800-811-8480
Brian I. Rini
- Recruiting
Houston Methodist Saint John Hospital
Nassau Bay, Texas, 77058
Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org
Patrick E. Prath
- Recruiting
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi, 38652
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Osarenren Ogbeide
- Recruiting
The Hospital of Central Connecticut
New Britain, Connecticut, 06050
Site Public Contact, 860-224-5660
Michael Sun
- Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Site Public Contact, 732-235-7356
Biren Saraiya
- Recruiting
Yale University
New Haven, Connecticut, 06520
Site Public Contact, 203-785-5702, canceranswers@yale.edu
David A. Braun
- Recruiting
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
Site Public Contact, 504-842-8084, Elisemarie.curry@ochsner.org
Brian T. Halbert
- Recruiting
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Mount Sinai Chelsea
New York, New York, 10011
Site Public Contact, 212-824-7309, CCTO@mssm.edu
Eric J. Miller
- Recruiting
Mount Sinai Hospital
New York, New York, 10029
Site Public Contact, 212-824-7309, CCTO@mssm.edu
Eric J. Miller
- Recruiting
Manhattan Eye Ear and Throat Hospital
New York, New York, 10065
Site Public Contact, 212-434-4460
Xinhua Zhu
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Site Public Contact, 212-639-7592
Darren R. Feldman
- Recruiting
Lenox Hill Hospital
New York, New York, 10075
Site Public Contact, 516-734-8896
Xinhua Zhu
- Recruiting
Helen F Graham Cancer Center
Newark, Delaware, 19713
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Rutgers New Jersey Medical School
Newark, New Jersey, 07101
Site Public Contact, 732-235-7356
Biren Saraiya
- Recruiting
Providence Newberg Medical Center
Newberg, Oregon, 97132
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Alison K. Conlin
- Recruiting
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, 92663
Site Public Contact, 323-865-0451
Varsha Tulpule
- Recruiting
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, 49120
Site Public Contact, 616-391-1230
Kathleen Y. Butler
- Suspended
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, 06473
- Suspended
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, 49444
- Recruiting
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Northwestern Medicine Oak Brook
Oak Brook, Illinois, 60523
Site Public Contact, nctnprogram_rhlccc@northwestern.edu
David VanderWeele
- Recruiting
Drexel Town Square Health Center
Oak Creek, Wisconsin, 53154
Site Public Contact, 414-805-0505
Kathryn A. Bylow
- Recruiting
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453-2699
Site Public Contact, 800-323-8622
Adam P. Siegel
- Recruiting
Advocate Outpatient Center - Oak Lawn
Oak Lawn, Illinois, 60453
Site Public Contact, ncorp@aah.org
Adam P. Siegel
- Recruiting
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066
Site Public Contact, 262-928-7878
Timothy R. Wassenaar
- Recruiting
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, 54154
Site Public Contact, 920-433-8889, WI_research_admin@hshs.org
Anthony J. Jaslowski
About this study
Official title: Short TeRm Intensified Pembrolizumab (KEytruda) and Tivozanib for High-Risk Renal Cell Carcinoma - STRIKE
This phase III trial compares the effect of adding tivozanib to standard therapy pembrolizumab versus pembrolizumab alone for the treatment of patients with high-risk renal cell carcinoma (RCC). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Tivozanib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals tumor cells to multiply. This helps stop the spread of tumor cells. Giving pembrolizumab and tivozanib together may work better than pembrolizumab alone in treating patients with RCC.
Read the detailed description
PRIMARY OBJECTIVE:
- To compare disease free survival (DFS) as assessed by the investigator for high-risk renal cell carcinoma patients treated with adjuvant pembrolizumab and tivozanib versus those receiving pembrolizumab alone.
SECONDARY OBJECTIVES:
- To compare overall survival (OS) for patients treated with adjuvant pembrolizumab and tivozanib versus those receiving pembrolizumab alone.
II. To assess adverse events in each study arm by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
BIOBANKING OBJECTIVE:
- To bank specimens for future unspecified research.
QUALITY OF LIFE (QOL) OBJECTIVES:
- To compare global quality of life (QOL) for patients treated with pembrolizumab and tivozanib versus those receiving pembrolizumab alone.
II. To compare patient-reported fatigue for patients treated with pembrolizumab and tivozanib versus those receiving pembrolizumab alone.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive pembrolizumab intravenously (IV) on days 1 and 43 of each cycle, or on days 1, 22, 43 and 64 of each cycle. Cycles repeat every 12 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and magnetic resonance imaging (MRI) or computed tomography (CT) throughout the trial and may undergo tissue biopsy on study.
ARM II: Patients receive pembrolizumab IV on days 1 and 43 of each cycle and tivozanib orally (PO) once daily (QD) on days 1-21, days 29-49, and days 57-77 of each cycle for up to 6 months. Cycles repeat every 12 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and MRI or CT throughout the trial and may undergo tissue biopsy on study.
After completion of study treatment, patients are followed up every 4 months for 2 years, then every 6 months for 3 years, then every subsequent year for 5 years.
- Conditions
- Clear Cell Renal Cell Carcinoma, Renal Cell Carcinoma (RCC), Stage II Renal Pelvis Cancer AJCC v8, Stage III Renal Pelvis Cancer AJCC v8
- Being tested
- Pembrolizumab, Tivozanib, Biospecimen Collection, MRI, Computed Tomography
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabBiological
Also called Keytruda
Given intravenously
TivozanibDrug
Given orally
Biospecimen CollectionProcedure or surgery
Undergo blood sample collection
MRIProcedure or surgery
Undergo MRI
Computed TomographyProcedure or surgery
Also called CT Scan, CAT Scan
Undergo CT scan
BiopsyProcedure or surgery
Undergo biopsy
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (Pembrolizumab) | Active comparator | Patients receive pembrolizumab IV on days 1 and 43 of each cycle, or on days 1, 22, 43 and 64 of each cycle. Cycles repeat every 12 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and MRI or CT throughout the trial and may undergo tissue biopsy on study. Receives: Biological: Pembrolizumab; Procedure: Biospecimen Collection; Procedure: MRI; Procedure: Computed Tomography; Procedure: Biopsy; Other: Questionnaire Administration |
| Arm 2 (pembrolizumab + tivozanib) | Experimental | Patients receive pembrolizumab IV on days 1 and 43 of each cycle and tivozanib PO QD on days 1-21, days 29-49, and days 57-77 of each cycle for up to 6 months. Cycles repeat every 12 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and MRI or CT throughout the trial and may undergo tissue biopsy on study. Receives: Biological: Pembrolizumab; Drug: Tivozanib; Procedure: Biospecimen Collection; Procedure: MRI; Procedure: Computed Tomography; Procedure: Biopsy; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (DFS)
The primary analysis will be a comparison of DFS between the two study arms using a stratified log-rank test. The treatment effect will be estimated with a hazard ratio (HR) and corresponding 95% confidence interval obtained from a stratified Cox model with treatment group (experimental group versus control group) as the explanatory variable. Interim analyses: There will be several futility analyses for the trial. These analyses will employ the linear 20% method proposed by Freidlin, Korn and Gray. Based on the current design parameters, the first analysis would be performed at 37% information (99 DFS events), and the trial would be stopped for futility if the observed hazard ratio (experimental versus [vs.] control) were worse than 1. Additional analyses will be performed at 50% (133 DFS events), 60% (159 DFS events), and 70% information (186 DFS events), the trial would be stopped for futility if the observed HR were worse than 0.983, 0.971 and 0.959, respectively.
Measured: From time of randomization until disease recurrence or death, assessed up to 10 years
Secondary outcomes (3)
Overall survival (OS)
The OS will be compared between the two treatment arms using a stratified log-rank test. An estimate of the OS difference between the arms will be made with a HR generated by a stratified Cox model. A point estimate and 95% confidence interval will be generated. If there are clinically meaningful imbalances between the treatment arms, a secondary analysis for DFS will be performed with a multivariable Cox model that includes the stratification variable and all baseline variables with meaningful differences. A similar analysis will be done for the OS endpoint. Key subgroup analyses will be performed to determine whether there is evidence that the treatment effect differs among subgroups that correspond to key prognostic variables. This includes the stratification variable.
Measured: From time of randomization until death, assessed up to 10 years
Incidence of adverse events (AEs)
These will be assessed using Common Terminology Criteria for Adverse Events version 5.0. Adverse events will be summarized with frequencies and relative frequencies. The maximum grade for an AE will be recorded for each patient by treatment arm. The number (percent) of patients that experience each observed adverse event will be summarized by treatment arm. In addition, the proportion of patients that experience a grade 3+, grade 4+, and grade 5 adverse event will be summarized as the number and percent of patients by treatment arm. The primary summary will be regardless of attribution. Will also have an analogous summary for the adverse events that were deemed at least possibly related to treatment.
Measured: From baseline to 10 years after registration
Proportion of patients that tolerate pembrolizumab and tivozanib
Tolerability will be defined as the ability of a patient to receive at least half the planned doses of tivozanib in combination with pembrolizumab if they have not had a DFS event. This will be determined as the number of patients on arm 2 who received at least one dose of tivozanib, who have not had a DFS within 6 months, and who received at half of the planned doses tivozanib divided by the number of patients on arm 2 who received at least one dose of tivozanib and who have not had a DFS within 6 months. The proportion of patients who tolerated tivozanib in combination with pembrolizumab will be estimated with a binomial point estimate and 95% binomial confidence interval.
Measured: From day 1 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start14 Mar 2025
- Primary completionNov 2037 (estimated)
- Study completionNov 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clear Cell Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,040 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661720
- Sponsor's protocol ID
- A032201
- Other IDs
- NCI-2024-08233
- Acronym
- STRIKE
- Status last verified
- Nov 2026
- First submitted
- 25 Oct 2024
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short TeRm Intensified Pembrolizumab (KEytruda) and Tivozanib for High-Risk Renal Cell Carcinoma - STRIKE
- ClinicalTrials.gov ID
- NCT06661720
- Acronym / sponsor ID
- STRIKE / A032201
- Conditions
- Clear Cell Renal Cell Carcinoma, Renal Cell Carcinoma (RCC), Stage II Renal Pelvis Cancer AJCC v8, Stage III Renal Pelvis Cancer AJCC v8
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,040 participants (estimated)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- Nov 2037 (estimated)
- Study completion
- Nov 2037 (estimated)
- First posted
- 28 Oct 2024 (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 III trial compares the effect of adding tivozanib to standard therapy pembrolizumab versus pembrolizumab alone for the treatment of patients with high-risk renal cell carcinoma (RCC). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Tivozanib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals tumor cells to multiply. This helps stop the spread of tumor cells. Giving pembrolizumab and tivozanib together may work better than pembrolizumab alone in treating patients with RCC.
Detailed description
PRIMARY OBJECTIVE:
- To compare disease free survival (DFS) as assessed by the investigator for high-risk renal cell carcinoma patients treated with adjuvant pembrolizumab and tivozanib versus those receiving pembrolizumab alone.
SECONDARY OBJECTIVES:
- To compare overall survival (OS) for patients treated with adjuvant pembrolizumab and tivozanib versus those receiving pembrolizumab alone.
II. To assess adverse events in each study arm by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
BIOBANKING OBJECTIVE:
- To bank specimens for future unspecified research.
QUALITY OF LIFE (QOL) OBJECTIVES:
- To compare global quality of life (QOL) for patients treated with pembrolizumab and tivozanib versus those receiving pembrolizumab alone.
II. To compare patient-reported fatigue for patients treated with pembrolizumab and tivozanib versus those receiving pembrolizumab alone.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive pembrolizumab intravenously (IV) on days 1 and 43 of each cycle, or on days 1, 22, 43 and 64 of each cycle. Cycles repeat every 12 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and magnetic resonance imaging (MRI) or computed tomography (CT) throughout the trial and may undergo tissue biopsy on study.
ARM II: Patients receive pembrolizumab IV on days 1 and 43 of each cycle and tivozanib orally (PO) once daily (QD) on days 1-21, days 29-49, and days 57-77 of each cycle for up to 6 months. Cycles repeat every 12 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and MRI or CT throughout the trial and may undergo tissue biopsy on study.
After completion of study treatment, patients are followed up every 4 months for 2 years, then every 6 months for 3 years, then every subsequent year for 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (Pembrolizumab) | Active comparator | Biological: Pembrolizumab, Procedure: Biospecimen Collection, Procedure: MRI, Procedure: Computed Tomography, Procedure: Biopsy, Other: Questionnaire AdministrationPatients receive pembrolizumab IV on days 1 and 43 of each cycle, or on days 1, 22, 43 and 64 of each cycle. Cycles repeat every 12 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and MRI or CT throughout the trial and may undergo tissue biopsy on study. |
| Arm 2 (pembrolizumab + tivozanib) | Experimental | Biological: Pembrolizumab, Drug: Tivozanib, Procedure: Biospecimen Collection, Procedure: MRI, Procedure: Computed Tomography, Procedure: Biopsy, Other: Questionnaire AdministrationPatients receive pembrolizumab IV on days 1 and 43 of each cycle and tivozanib PO QD on days 1-21, days 29-49, and days 57-77 of each cycle for up to 6 months. Cycles repeat every 12 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and MRI or CT throughout the trial and may undergo tissue biopsy on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (49 listed)
- • Histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features following complete resection of the primary tumor (radical or partial nephrectomy)
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 |
|---|---|---|
| PembrolizumabAlso: KeytrudaGiven intravenously | Biological | Arm 1 (Pembrolizumab), Arm 2 (pembrolizumab + tivozanib) |
| TivozanibGiven orally | Drug | Arm 2 (pembrolizumab + tivozanib) |
| Biospecimen CollectionUndergo blood sample collection | Procedure or surgery | Arm 1 (Pembrolizumab), Arm 2 (pembrolizumab + tivozanib) |
| MRIUndergo MRI | Procedure or surgery | Arm 1 (Pembrolizumab), Arm 2 (pembrolizumab + tivozanib) |
| Computed TomographyAlso: CT Scan, CAT ScanUndergo CT scan | Procedure or surgery | Arm 1 (Pembrolizumab), Arm 2 (pembrolizumab + tivozanib) |
| BiopsyUndergo biopsy | Procedure or surgery | Arm 1 (Pembrolizumab), Arm 2 (pembrolizumab + tivozanib) |
| Questionnaire AdministrationAncillary studies | Other | Arm 1 (Pembrolizumab), Arm 2 (pembrolizumab + tivozanib) |
Primary outcome
Disease-free survival (DFS)
Time frame: From time of randomization until disease recurrence or death, assessed up to 10 years
The primary analysis will be a comparison of DFS between the two study arms using a stratified log-rank test. The treatment effect will be estimated with a hazard ratio (HR) and corresponding 95% confidence interval obtained from a stratified Cox model with treatment group (experimental group versus control group) as the explanatory variable. Interim analyses: There will be several futility analyses for the trial. These analyses will employ the linear 20% method proposed by Freidlin, Korn and Gray. Based on the current design parameters, the first analysis would be performed at 37% information (99 DFS events), and the trial would be stopped for futility if the observed hazard ratio (experimental versus [vs.] control) were worse than 1. Additional analyses will be performed at 50% (133 DFS events), 60% (159 DFS events), and 70% information (186 DFS events), the trial would be stopped for futility if the observed HR were worse than 0.983, 0.971 and 0.959, respectively.
3 secondary outcomes
Overall survival (OS)
Time frame: From time of randomization until death, assessed up to 10 years
Incidence of adverse events (AEs)
Time frame: From baseline to 10 years after registration
Proportion of patients that tolerate pembrolizumab and tivozanib
Time frame: From day 1 to 6 months
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 3 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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.
429 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pembrolizumab, Tivozanib and Biospecimen Collection in people with Clear Cell Renal Cell Carcinoma and Renal Cell Carcinoma (RCC), run by Alliance for Clinical Trials in Oncology at 429 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 49 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 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 429 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Aishwarya Vijendran (773-702-9171, guprotocols@alliancenctn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (DFS) (time frame: From time of randomization until disease recurrence or death, assessed up to 10 years). 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 3 Nov 2026.