Metastatic Clear Cell Renal Cell CarcinomaPhase 3PROBENCT04510597
Comparing the Outcome of Immunotherapy-Based Drug Combination Therapy With or Without Surgery to Remove the Kidney in Metastatic Kidney Cancer, the PROBE Trial
A Phase 3 study testing Cytoreductive Nephrectomy and Active Comparator in people with Metastatic Clear Cell Renal Cell Carcinoma and Metastatic Renal Cell Carcinoma, run by SWOG Cancer Research Network at 387 sites in United States.
Trial summary
This phase III trial compares the effect of adding surgery to a standard of care immunotherapy-based drug combination versus a standard of care immunotherapy-based drug combination alone in treating patients with kidney cancer that has spread to other places in the body (metastatic). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Clear Cell Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8
- What is being tested?
- Cytoreductive Nephrectomy and Active Comparator
- 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
- 364 participants
- Where
- 387 sitesUnited States
- Study dates
- 8 Mar 2021to Jul 2033
- 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
- STEP 1 REGISTRATION: Participants must have a histologically proven diagnosis of clear cell or non-clear cell renal cell carcinoma. Participants with collecting duct carcinoma histology are not eligible. Participants with multifocal or bilateral tumors are eligible
- STEP 1 REGISTRATION: Participants must have primary tumor in place
- STEP 1 REGISTRATION: Participants must have the following scans performed, showing clinical evidence of measurable or non-measurable metastatic disease:
- Computed tomography (CT) scan of the chest (can be performed without contrast if CT contrast cannot be given)
- CT of abdomen and pelvis with contrast OR magnetic resonance imaging (MRI) of the abdomen and pelvis with or without contrast
- Scans must be performed within the following timeframes:
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- Treatment naive participants must have scans documenting metastatic disease completed within 90 days prior to study registration
- Previously treated participants must have scans documenting metastatic disease completed within 90 days prior to first dose of systemic treatment
- STEP 1 REGISTRATION: Participants with symptomatic metastases may have received palliative radiotherapy or receive palliative radiotherapy after registration
- STEP 1 REGISTRATION: Participants must have no clear contraindications to nephrectomy
- STEP 1 REGISTRATION: Participants must be offered the opportunity to participate in specimen bank. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System
- STEP 1 REGISTRATION: 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
- STEP 1 REGISTRATION: As part of the Oncology Patient Enrollment Network (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
- STEP 2 REGISTRATION: Participants must have at least one of the following scans performed 12 weeks (+/- 2 weeks) after starting pre-randomization treatment
- CT scan of the chest (can be performed without contrast if CT contrast cannot be given)
- CT of abdomen and pelvis with contrast OR MRI of the abdomen and pelvis with or without contrast Scans must be performed within 28 days prior to randomization. Response should be assessed by comparing with a CT or MRI of the chest, abdomen and pelvis obtained prior to starting pre-randomization treatment. Participants with complete response in all metastatic sites are not eligible to randomize to Step 2
- STEP 2 REGISTRATION: Participants must have one of the following objective statuses after 12 weeks of pre-randomization treatment
- Stable disease
- Partial response
- The treating investigator believes the patient is deriving clinical benefit from systemic therapy AND have Zubrod performance status 0-1
- STEP 2 REGISTRATION: Participants must plan to continue the immune-based therapy received during pre-randomization treatment
- STEP 2 REGISTRATION: Participants must be randomized on or between the 11th and 14th week of protocol-directed pre-randomization treatment therapy
- STEP 2 REGISTRATION: Participants must have received at least one of the minimum amounts of immunotherapy:
- 2 infusions of nivolumab + 1 infusion of ipilimumab
- 2 infusions of pembrolizumab
- 2 infusions of avelumab
- STEP 2 REGISTRATION: Participants must have a planned surgery date within 42 days of randomization
- STEP 2 REGISTRATION: Participants must be a surgical candidate as determined by study urologist. The urology consult should be done within 42 days prior to randomization
- STEP 2 REGISTRATION: Participants must have a complete physical examination and medical history within 28 days prior to randomization
- STEP 2 REGISTRATION: Participants must have a Zubrod performance status of 0-1 within 28 days prior to randomization
- STEP 2 REGISTRATION: Total bilirubin =< institutional upper limit of normal (ULN) (within 28 days prior to randomization)
- STEP 2 REGISTRATION: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x institutional upper limit of normal (ULN) (within 28 days prior to randomization)
- STEP 2 REGISTRATION: Serum creatinine =< 1.5 x the institutional upper limit of normal (IULN) OR measured OR calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault Formula) (must have been drawn and processed within 28 days prior to randomization)
Who cannot join
- STEP 1 REGISTRATION: Participants must not have known active brain metastases. Participants with previously treated brain metastases are eligible if participant has no neurologic signs or symptoms suggestive of brain metastasis. Brain imaging studies are not required. If brain imaging studies are performed, they must be negative for disease
- STEP 1 REGISTRATION: Participants must not have received the following prior treatment of metastatic renal cell carcinoma:
- Treatment naive participants must not have received any prior lines of systemic therapy for metastatic renal cell carcinoma beyond the line intended as part of protocol therapy
- Previously treated participants must not have received any systemic therapy for metastatic renal cell carcinoma beyond the one regimen received off protocol as specified in Step 1 pre-randomization treatment
- STEP 1 REGISTRATION: Participants must not have received more than the following amounts protocol-directed pre-randomization treatment:
- Treatment naive participants must not have received any pre-randomization treatment.
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- Previously treated participants must not be planning to receive any additional treatment prior to Step 2 randomization, and must not have received more than the following amounts of pre-randomization treatment:
- 4 infusions of nivolumab
- 4 infusions of ipilimumab
- 4 infusions of pembrolizumab
- 7 infusions of avelumab
- STEP 1 REGISTRATION: Participants must not have received immunotherapy for any cancer within the following timeframes:
- Treatment naive participants must not have received any immunotherapy within a year of registration
- Previously treated participants must not have received any other immunotherapy within a year of the start of off protocol specified pre-randomization treatment
- STEP 1 REGISTRATION: Participants must not have a solitary kidney and not have a transplanted kidney
- STEP 1 REGISTRATION: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, any in situ or T1 cancer, adequately treated stage I or II cancer from which the participant is currently in complete remission, or any other cancer from which the participant has been disease free for at least two years
- STEP 1 REGISTRATION: Participants must not have been previously diagnosed with a medical condition that makes them ineligible for immune based combination therapy or nephrectomy
- STEP 2 REGISTRATION: Participants must not show progression in the primary tumor. Participants who are considered to have pseudo progression are allowed
- STEP 2 REGISTRATION: Participants must not have known active brain metastases. Participants with previously treated brain metastases are eligible if participant has no neurologic signs or symptoms suggestive of brain metastasis. Brain imaging studies are not required. If brain imaging studies are performed, they must be negative for disease
- STEP 2 REGISTRATION: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the participant is currently in complete remission, or any other cancer from which the participant has been disease free for two years
Trial locations and contacts
387 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, 262 recruiting
- Recruiting
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102
Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu
Neda Hashemi Sadraei
- Recruiting
AdventHealth Altamonte
Altamonte Springs, Florida, 32701
Site Public Contact, 407-303-2200
Carlos A. Alemany
- Recruiting
Saint Anthony's Health
Alton, Illinois, 62002
Site Public Contact, 618-463-5623
Jay W. Carlson
- Recruiting
UPMC Altoona
Altoona, Pennsylvania, 16601
Site Public Contact, protocols@swog.org
Risa L. Wong
- 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
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Site Public Contact, 800-865-1125
Ulka N. Vaishampayan
- Recruiting
PCR Oncology
Arroyo Grande, California, 93420
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Sutter Auburn Faith Hospital
Auburn, California, 95602
Site Public Contact, Melanie.Cook@sutterhealth.org
Ari D. Baron
- Recruiting
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, 95603
Site Public Contact, Melanie.Cook@sutterhealth.org
Ari D. Baron
- Recruiting
Rush - Copley Medical Center
Aurora, Illinois, 60504
Site Public Contact, 630-978-6212, Cancer.Research@rushcopley.com
Priyank P. Patel
- Recruiting
UH Seidman Cancer Center at UH Avon Health Center
Avon, Ohio, 44011
Site Public Contact, 800-641-2422
Pedro Barata
- Recruiting
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri, 63011
Site Public Contact, 314-251-7058
Jay W. Carlson
- Recruiting
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010
Site Public Contact, 847-842-4847
Adam P. Siegel
- Suspended
Hematology/Oncology Clinic PLLC
Baton Rouge, Louisiana, 70809
- 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
Pedro Barata
- Recruiting
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania, 15009
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Risa L. Wong
- Recruiting
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Suspended
Overlake Medical Center
Bellevue, Washington, 98004
- Recruiting
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704
Site Public Contact, Melanie.Cook@sutterhealth.org
Ari D. Baron
- Recruiting
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
Site Public Contact, 205-934-0220, tmyrick@uab.edu
Arnab Basu
- 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
- Active, not recruiting
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316
- 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
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
Ulka N. Vaishampayan
- Active, not recruiting
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, 48183
- Recruiting
Keck Medicine of USC Buena Park
Buena Park, California, 90621
Site Public Contact, 714-522-0908
Varsha Tulpule
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Site Public Contact, 800-767-9355, askroswell@roswellpark.org
Saby George
- Recruiting
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105
Site Public Contact, 414-302-2304, ncorp@aurora.org
Adam P. Siegel
- 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
Loyola Center for Health at Burr Ridge
Burr Ridge, Illinois, 60527
Site Public Contact, 708-216-9000
Joseph I. Clark
- Recruiting
UPMC Hillman Cancer Center at Butler Health System
Butler, Pennsylvania, 16001
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Risa L. Wong
- Recruiting
Cambridge Medical Center
Cambridge, Minnesota, 55008
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, 95682
Site Public Contact, Melanie.Cook@sutterhealth.org
Ari D. Baron
- 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
- Active, not recruiting
Saint Anthony Regional Hospital
Carroll, Iowa, 51401
- Recruiting
Carson Tahoe Regional Medical Center
Carson City, Nevada, 89703
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- 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
Eden Hospital Medical Center
Castro Valley, California, 94546
Site Public Contact, Melanie.Cook@sutterhealth.org
Ari D. Baron
- Recruiting
AdventHealth Celebration
Celebration, Florida, 34747
Site Public Contact, 407-303-4120
Carlos A. Alemany
- 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
Medical University of South Carolina
Charleston, South Carolina, 29425
Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu
Robert L. Grubb
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Site Public Contact, 312-695-1301, cancer@northwestern.edu
Jeffrey A. Sosman
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Site Public Contact, 312-942-5498, clinical_trials@rush.edu
Alan Tan
- Recruiting
University of Illinois
Chicago, Illinois, 60612
Site Public Contact, 312-355-3046
Daniel Moreira
- Active, not recruiting
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
- Recruiting
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
Site Public Contact, 773-296-5360
Adam P. Siegel
- Recruiting
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, 54729
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Seth O. Fagbemi
- Recruiting
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219
Site Public Contact, 513-584-7698, cancer@uchealth.com
Robert A. Franklin
- Recruiting
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Kaiser Sunnyside Medical Center
Clackamas, Oregon, 97015
Site Public Contact, 503-335-2400, information@kpchr.org
Sandeep H. Mashru
- Recruiting
Case Western Reserve University
Cleveland, Ohio, 44106
Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org
Pedro Barata
- Active, not recruiting
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, 28328
- Active, not recruiting
Henry Ford Hematology Oncology - Hayes
Clinton Township, Michigan, 48038
- Active, not recruiting
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Site Public Contact, 800-293-5066, Jamesline@osumc.edu
Shawn Dason
- Recruiting
Mercy Hospital
Coon Rapids, Minnesota, 55433
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, 60014
Site Public Contact, 630-929-6129, advocateresearch@advocate.com
Adam P. Siegel
- Recruiting
UT Southwestern Simmons Cancer Center - RedBird
Dallas, Texas, 75237
Site Public Contact, 214-648-7097, canceranswerline@utsouthwestern.edu
Suzanne M. Cole
- Recruiting
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu
Suzanne M. Cole
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
Site Public Contact, 800-446-5532, Research@Carle.com
Priyank P. Patel
- Recruiting
Sutter Davis Hospital
Davis, California, 95616
Site Public Contact, Melanie.Cook@sutterhealth.org
Ari D. Baron
- 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
- Active, not recruiting
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, 48126
- 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
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Jeffrey A. Sosman
- Active, not recruiting
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
- Active, not recruiting
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309
- Active, not recruiting
Broadlawns Medical Center
Des Moines, Iowa, 50314
- Active, not recruiting
Iowa Lutheran Hospital
Des Moines, Iowa, 50316
- Active, not recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
- 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
Abhishek Tripathi
- Active, not recruiting
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640
- Recruiting
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Seth O. Fagbemi
- Recruiting
Fairview Southdale Hospital
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Site Public Contact, 800-446-5532, Research@carle.com
Priyank P. Patel
- 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
Brian C. Myre
- Recruiting
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, 16505
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Risa L. Wong
- Recruiting
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Parkland Health Center - Farmington
Farmington, Missouri, 63640
Site Public Contact, 314-996-5569
Bryan A. Faller
- Recruiting
UPMC Cancer Center at UPMC Horizon
Farrell, Pennsylvania, 16121
Site Public Contact, protocols@swog.org
Risa L. Wong
- 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
- Active, not recruiting
Trinity Regional Medical Center
Fort Dodge, Iowa, 50501
- Recruiting
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
Site Public Contact, 800-378-9373
Jay W. Carlson
- Recruiting
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas, 76104
Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu
Suzanne M. Cole
- 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
Palo Alto Medical Foundation-Fremont
Fremont, California, 94538
Site Public Contact, Melanie.Cook@sutterhealth.org
Ari D. Baron
- Recruiting
Unity Hospital
Fridley, Minnesota, 55432
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- 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
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Jeffrey A. Sosman
- Recruiting
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022
Site Public Contact, 414-302-2304, ncorp@aurora.org
Adam P. Siegel
- Recruiting
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Site Public Contact, 602-747-9738
Chinedu Mmeje
- Active, not recruiting
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, 27534
- Recruiting
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024
Site Public Contact, 414-302-2304, ncorp@aurora.org
Adam P. Siegel
- 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
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
Risa L. Wong
- 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
- Active, not recruiting
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605
- Active, not recruiting
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
- Active, not recruiting
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605
- Active, not recruiting
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615
- Active, not recruiting
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650
- Recruiting
Gulfport Memorial Hospital
Gulfport, Mississippi, 39502
Site Public Contact, 504-210-3539, emede1@lsuhsc.edu
Jessie R. Gills
- Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Site Public Contact, 201-996-2879
Robert S. Alter
- Recruiting
Advocate South Suburban Hospital
Hazel Crest, Illinois, 60429
Site Public Contact, 708-799-9995
Adam P. Siegel
- Recruiting
Cancer and Blood Specialists-Henderson
Henderson, Nevada, 89052
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, 89052
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson, Nevada, 89052
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Suspended
Las Vegas Cancer Center-Henderson
Henderson, Nevada, 89052
- Recruiting
OptumCare Cancer Care at Seven Hills
Henderson, Nevada, 89052
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada, 89074
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
GenesisCare USA - Henderson
Henderson, Nevada, 89074
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Las Vegas Urology - Green Valley
Henderson, Nevada, 89074
Site Public Contact, research@sncrf.org
John A. Ellerton
- Recruiting
Las Vegas Urology - Pebble
Henderson, Nevada, 89074
Site Public Contact, research@sncrf.org
John A. Ellerton
- Recruiting
Urology Specialists of Nevada - Green Valley
Henderson, Nevada, 89074
Site Public Contact, research@sncrf.org
John A. Ellerton
- Recruiting
Loyola Medicine Homer Glen
Homer Glen, Illinois, 60491
Site Public Contact, 708-216-9000
Joseph I. Clark
- 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
Keck Medicine of USC Huntington Beach
Huntington Beach, California, 92648
Site Public Contact, 714-861-1000, karenn@pacshoresoncology.com
Varsha Tulpule
- Recruiting
IRMC Cancer Center
Indiana, Pennsylvania, 15701
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Risa L. Wong
- Active, not recruiting
Allegiance Health
Jackson, Michigan, 49201
- Active, not recruiting
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, 28546
- 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
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania, 15901
Site Public Contact, 814-534-4724
Risa L. Wong
- 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
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142
Site Public Contact, 414-302-2304, ncorp@aurora.org
Adam P. Siegel
- 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
Kingman Regional Medical Center
Kingman, Arizona, 86401
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
AdventHealth Kissimmee
Kissimmee, Florida, 34744
Site Public Contact, 407-846-4343
Carlos A. Alemany
- Recruiting
Marshfield Clinic - Ladysmith Center
Ladysmith, Wisconsin, 54848
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Seth O. Fagbemi
- Recruiting
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045
Site Public Contact, cancertrials@northwestern.edu
Jeffrey A. Sosman
- Recruiting
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042
Site Public Contact, 516-734-8896
Thomas P. Bradley
- Recruiting
Las Vegas Urology - Pecos
Las Vegas, Nevada, 89074
Site Public Contact, research@sncrf.org
John A. Ellerton
- Suspended
Desert West Surgery
Las Vegas, Nevada, 89102
- Recruiting
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, 89102
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Hope Cancer Care of Nevada
Las Vegas, Nevada, 89103
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, 89106
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Urology Specialists of Nevada - Central
Las Vegas, Nevada, 89106
Site Public Contact, research@sncrf.org
John A. Ellerton
- Recruiting
GenesisCare USA - Las Vegas
Las Vegas, Nevada, 89109
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Las Vegas Prostate Cancer Center
Las Vegas, Nevada, 89113
Site Public Contact, research@sncrf.org
John A. Ellerton
- Recruiting
Las Vegas Urology - Sunset
Las Vegas, Nevada, 89113
Site Public Contact, research@sncrf.org
John A. Ellerton
- Recruiting
Urology Specialists of Nevada - Southwest
Las Vegas, Nevada, 89113
Site Public Contact, research@sncrf.org
John A. Ellerton
- Recruiting
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada, 89119
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Ann M Wierman MD LTD
Las Vegas, Nevada, 89128
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada, 89128
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
GenesisCare USA - Vegas Tenaya
Las Vegas, Nevada, 89128
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Las Vegas Urology - Cathedral Rock
Las Vegas, Nevada, 89128
Site Public Contact, research@sncrf.org
John A. Ellerton
- Recruiting
Las Vegas Urology - Smoke Ranch
Las Vegas, Nevada, 89128
Site Public Contact, research@smcrf.org
John A. Ellerton
- Recruiting
OptumCare Cancer Care at MountainView
Las Vegas, Nevada, 89128
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Urology Specialists of Nevada - Northwest
Las Vegas, Nevada, 89128
Site Public Contact, research@sncrf.org
John A. Ellerton
- Recruiting
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada, 89144
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada, 89144
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Suspended
Las Vegas Cancer Center-Medical Center
Las Vegas, Nevada, 89148-2405
- Recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
GenesisCare USA - Fort Apache
Las Vegas, Nevada, 89148
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89148
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, 89169
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
University Cancer Center
Las Vegas, Nevada, 89169
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
Site Public Contact, 800-639-6918, cancer.research.nurse@dartmouth.edu
John D. Seigne
- Recruiting
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
Site Public Contact, 859-257-3379
Zin W. Myint
- 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
Keck Medicine of USC Koreatown
Los Angeles, California, 90020
Site Public Contact, 213-388-0908
Varsha Tulpule
- Recruiting
Los Angeles County-USC Medical Center
Los Angeles, California, 90033
Site Public Contact, 323-865-0451
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, 310-423-8965
Hyung L. Kim
- Recruiting
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
Site Public Contact, 888-798-0719
Brian Shuch
- Recruiting
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- 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
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
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Seth O. Fagbemi
- Recruiting
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Site Public Contact, 800-446-5532, Research@carle.com
Priyank P. Patel
- Recruiting
Loyola University Medical Center
Maywood, Illinois, 60153
Site Public Contact, 708-226-4357
Joseph I. Clark
- Recruiting
UPMC Cancer Center at UPMC McKeesport
McKeesport, Pennsylvania, 15132
Site Public Contact, 412-647-8073
Risa L. Wong
- Active, not recruiting
Rogue Valley Medical Center
Medford, Oregon, 97504
- Recruiting
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
Melrose Park, Illinois, 60160
Site Public Contact, 708-450-4554
Joseph I. Clark
- 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
Pedro Barata
- Recruiting
East Jefferson General Hospital
Metairie, Louisiana, 70006
Site Public Contact, 504-210-3539, emede1@lsuhsc.edu
Jessie R. Gills
- Recruiting
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie, Louisiana, 70006
Site Public Contact, 504-210-3539, emede1@lsuhsc.edu
Jessie R. Gills
- 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
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
Seth O. Fagbemi
- Recruiting
Memorial Medical Center
Modesto, California, 95355
Site Public Contact, Melanie.Cook@sutterhealth.org
Ari D. Baron
- Recruiting
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania, 15146
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Risa L. Wong
- Recruiting
Monticello Cancer Center
Monticello, Minnesota, 55362
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
UPMC Hillman Cancer Center - Part of Frick Hospital
Mount Pleasant, Pennsylvania, 15666
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Risa L. Wong
- Recruiting
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864
Site Public Contact, 618-242-4600
Jay W. Carlson
- Recruiting
Palo Alto Medical Foundation-Camino Division
Mountain View, California, 94040
Site Public Contact, Melanie.Cook@sutterhealth.org
Ari D. Baron
- Recruiting
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, 94040
Site Public Contact, Melanie.Cook@sutterhealth.org
Ari D. Baron
- Recruiting
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen J. Yost
- Recruiting
Arnold Palmer Cancer Center Medical Oncology Norwin
N. Huntingdon, Pennsylvania, 15642
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Risa L. Wong
- Recruiting
Edward Hospital/Cancer Center
Naperville, Illinois, 60540
Site Public Contact, 630-646-6075
Brian C. Myre
- Recruiting
UPMC Cancer Center-Natrona Heights
Natrona Heights, Pennsylvania, 15065
Site Public Contact, 724-230-3030
Risa L. Wong
- Recruiting
UPMC Hillman Cancer Center - New Castle
New Castle, Pennsylvania, 16105
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Risa L. Wong
- Active, not recruiting
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, 60451
- Recruiting
Louisiana State University Health Science Center
New Orleans, Louisiana, 70112
Site Public Contact, 504-210-3539, emede1@lsuhsc.edu
Jessie R. Gills
- Recruiting
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
Site Public Contact, 504-988-6121
Mark Sides
- Recruiting
University Medical Center New Orleans
New Orleans, Louisiana, 70112
Site Public Contact, 504-210-3539, emede1@lsuhsc.edu
Jessie R. Gills
- 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
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, 92663
Site Public Contact, 323-865-0451
Varsha Tulpule
- 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
Sutter Cancer Research Consortium
Novato, California, 94945
Site Public Contact, Melanie.Cook@sutterhealth.org
Ari D. Baron
- Active, not recruiting
Henry Ford Medical Center-Columbus
Novi, Michigan, 48377
- 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
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
- Suspended
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
- Recruiting
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120
Site Public Contact, 405-752-3402
Jay W. Carlson
- Recruiting
Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
Omaha, Nebraska, 68114
Site Public Contact, 402-334-4773
Ralph J. Hauke
- Recruiting
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
Site Public Contact, 402-354-5144
Ralph J. Hauke
- Recruiting
Oncology Associates PC
Omaha, Nebraska, 68114
Site Public Contact, 402-354-5860, info@oa-oc.com
Ralph J. Hauke
- Active, not recruiting
University of Chicago Medicine-Orland Park
Orland Park, Illinois, 60462
- Recruiting
AdventHealth Medical Group Urology at Orlando
Orlando, Florida, 32803
Site Public Contact, 407-897-3499
Carlos A. Alemany
- Recruiting
AdventHealth Orlando
Orlando, Florida, 32803
Site Public Contact, 407-303-2090, FH.Cancer.Research@flhosp.org
Carlos A. Alemany
- Recruiting
Orlando Health Cancer Institute
Orlando, Florida, 32806
Site Public Contact, 321-841-7246, CancerClinicalTrials@orlandohealth.com
Daniel Landau
- Recruiting
AdventHealth East Orlando
Orlando, Florida, 32822
Site Public Contact, 407-303-8110
Carlos A. Alemany
- Recruiting
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904
Site Public Contact, 414-302-2304, ncorp@aurora.org
Adam P. Siegel
- Recruiting
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Hope Cancer Care of Nevada-Pahrump
Pahrump, Nevada, 89048
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Palo Alto Medical Foundation Health Care
Palo Alto, California, 94301
Site Public Contact, Melanie.Cook@sutterhealth.org
Ari D. Baron
- Recruiting
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
Site Public Contact, 847-384-3621
Adam P. Siegel
- Recruiting
Keck Medical Center of USC Pasadena
Pasadena, California, 91105
Site Public Contact, 323-865-0451
Varsha Tulpule
- 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
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
UPMC-Saint Margaret
Pittsburgh, Pennsylvania, 15215
Site Public Contact, 412-784-4900
Risa L. Wong
- Recruiting
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232
Site Public Contact, 412-647-8073
Risa L. Wong
- Recruiting
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
Site Public Contact, 412-621-2334
Risa L. Wong
- Recruiting
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, 15237
Site Public Contact, 412-367-6454
Risa L. Wong
- Recruiting
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania, 15243
Site Public Contact, 412-502-3920
Risa L. Wong
- Recruiting
Edward Hospital/Cancer Center?Plainfield
Plainfield, Illinois, 60585
Site Public Contact, 630-646-6075, Cancerresearch@edward.org
Brian C. Myre
- Recruiting
Kaiser Permanente Northwest
Portland, Oregon, 97227
Site Public Contact, 503-335-2400, information@kpchr.org
Sandeep H. Mashru
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Site Public Contact, 503-494-1080, trials@ohsu.edu
Christopher W. Ryan
- 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
Aurora Cancer Care-Racine
Racine, Wisconsin, 53406
Site Public Contact, 414-302-2304, ncorp@aurora.org
Adam P. Siegel
- Recruiting
Spectrum Health Reed City Hospital
Reed City, Michigan, 49677
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen J. Yost
- Recruiting
Renown Regional Medical Center
Reno, Nevada, 89502
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Saint Mary's Regional Medical Center
Reno, Nevada, 89503
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Radiation Oncology Associates
Reno, Nevada, 89509
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Valley Medical Center
Renton, Washington, 98055
Site Public Contact, 425-228-3440, research@valleymed.org
John A. Ellerton
- Recruiting
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Seth O. Fagbemi
- Recruiting
UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas, 75080
Site Public Contact, 972-669-7044, Suzanne.cole@utsouthwestern.edu
Suzanne M. Cole
- 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
About this study
Official title: Phase III Trial of Immunotherapy-Based Combination Therapy With or Without Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma (PROBE Trial)
This phase III trial compares the effect of adding surgery to a standard of care immunotherapy-based drug combination versus a standard of care immunotherapy-based drug combination alone in treating patients with kidney cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, pembrolizumab, and avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Surgery to remove the kidney, called a nephrectomy, is also considered standard of care; however, doctors who treat kidney cancer do not agree on its benefits. It is not yet known if the addition of surgery to an immunotherapy-based drug combination works better than an immunotherapy-based drug combination alone in treating patients with kidney cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- To compare overall survival in participants with newly diagnosed metastatic renal cell carcinoma who are randomized to receive immune checkpoint inhibitor-based combination treatment plus cytoreductive nephrectomy versus immune checkpoint inhibitor-based combination treatment alone.
SECONDARY OBJECTIVES:
- To compare overall survival between arms in the subset who received their assigned protocol treatment.
II. To assess complications of nephrectomy and post-randomization drug toxicities.
III. To compare objective response rate in metastatic sites between the arms in participants with measurable metastatic disease.
IV. To assess change in diameter of primary tumor at week 12 disease assessment in participants who have received pre-randomization treatment.
BANKING OBJECTIVE:
- To bank specimens for future correlative studies.
OUTLINE:
PRE-RANDOMIZATION TREATMENT: Treatment naive patients are assigned to 1 of 3 treatment regimens per standard of care.
REGIMEN I: Patients receive nivolumab intravenously (IV) and ipilimumab IV. Treatment repeats every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV on day 1. Cycles repeat every 2-4 weeks in the absence of disease progression or unacceptable toxicity.
REGIMEN II: Patients receive pembrolizumab IV on day 1 and axitinib orally (PO) twice daily (BID) on days 1-21. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
REGIMEN III: Patients receive avelumab IV on day 1 and axitinib PO BID on days 1-14. Cycles repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
NOTE: Some patients may have already completed the standard of care pre-randomization treatment specified above off-trial.
RANDOMIZATION TREATMENT: Between 10-14 weeks from the start of on-trial or off-trial pre-randomization treatment, patients are randomized to 1 of 2 arms.
ARM I: Patients receive nivolumab IV, pembrolizumab IV, or avelumab IV on day 1. Patients also receive axitinib PO BID. Cycles with nivolumab repeat every 2 or 4 weeks, cycles with pembrolizumab repeat every 3 weeks, and cycles with avelumab repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
ARM II: Within 42 days following randomization, patients undergo radical or partial nephrectomy in addition to nivolumab, pembrolizumab, avelumab, and axitinib as in Arm I in the absence of disease progression or unacceptable toxicity. Axitinib should be stopped at least 24 hours prior to surgery.
After completion of trial treatment, patients are followed up every 3 months for the first year, every 6 months for years 2 and 3, and then annually for up to 7 years from randomization.
- Conditions
- Metastatic Clear Cell Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8
- Being tested
- Cytoreductive Nephrectomy, Active Comparator
- Medical subject headings
- Clear-cell metastatic renal cell carcinoma, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytoreductive NephrectomyProcedure or surgery
Radical or partial nephrectomy may be performed using laparoscopic, open, or robotic approaches. Surgery should be performed within 8 weeks of randomization
Active ComparatorDrug
Nivolumab 240 mg IV 1 q 2 weeks
OR
Nivolumab 480 mg IV 1 q 4 weeks
OR
Pembrolizumab 200 mg IV 1 q 3 weeks Axitinib 5 mg oral Daily BID
OR
Avelumab 10 mg/kg IV 1 q 2 weeks Axitinib 5 mg oral Daily BID
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Continued Systemic Therapy Only | Active comparator | Nivolumab 240 mg IV 1 q 2 weeks
OR
Nivolumab 480 mg IV 1 q 4 weeks
OR
Pembrolizumab 200 mg IV 1 q 3 weeks Axitinib 5 mg oral Daily BID
OR
Avelumab 10 mg/kg IV 1 q 2 weeks Axitinib 5 mg oral Daily BID Receives: Procedure: Cytoreductive Nephrectomy; Drug: Active Comparator |
| Arm 2: Nephrectomy and Continued Systemic Therapy | Experimental | Continued systemic therapy as above, plus:
Radical or partial nephrectomy may be performed using laparoscopic, open, or robotic approaches. Surgery should be performed within 8 weeks of randomization. Receives: Procedure: Cytoreductive Nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Analysis will be intent-to-treat. Evidence suggesting early termination of the trial and a conclusion that the cytoreductive nephrectomy (CN) approach is superior to treatment alone would be if the null hypothesis is rejected at the one-sided 0.005 level. For the second and third interim analyses, the null and alternative hypotheses with respect to survival will be tested, with superiority tested at the one-sided 0.005 level, and futility determined to be met if the (CN versus no CN) hazard ratio is greater than or equal to 1. A proportional hazards model will be fit to estimate the hazard ratio adjusting for the stratification factors as covariates in the model. Will evaluate whether each of the stratification factors are predictive factors of cytoreductive nephrectomy by placing an interaction term corresponding to each stratification factor and treatment arm in the proportional hazards survival model.
Measured: From date of randomization to date of death due to any cause, assessed up to 7 years.
Secondary outcomes (4)
Overall survival in subset who received assigned protocol treatment
Will be included in the proportional hazards regression model adjusting for stratification factors as covariates.
Measured: From date of randomization to date of death due to any cause, assessed up to 7 years
Progression-free survival
A proportional hazards model will be used to compare progression-free survival between arms, adjusting for the stratification factors as covariates.
Measured: From date of randomization to date of first documentation of progression, or death due to any cause, assessed up to 7 years
Objective response
Objective response includes all confirmed and unconfirmed partial and complete responses. Baseline will be disease assessment at randomization. Response Evaluation Criteria in Solid Tumors response rates will be evaluated, excluding the primary tumor in the kidney because that disease will be removed in half the participant's post-randomization. Comparison of response rates will be performed using logistic regression with stratification factors as covariates and an indicator for treatment arm.
Measured: Up to 7 years
Change in maximum diameter of primary tumor
Descriptive statistics will be provided including stratified results by treatment regimen received. Potential additional analyses may include assessment of the interaction between change in primary tumor and randomized treatment arm. This will be modeled as an interaction term in the proportional hazards survival model.
Measured: From the disease assessment just prior to the start of immunotherapy to the week 12 disease assessment
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 start8 Mar 2021
- Primary completionJul 2033 (estimated)
- Study completionJul 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic Clear Cell Renal Cell CarcinomaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 364 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510597
- Sponsor's protocol ID
- S1931
- Other IDs
- NCI-2020-04442
- Acronym
- PROBE
- Status last verified
- Oct 2026
- First submitted
- 10 Aug 2020
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bell H, Cotta BH, Salami SS, Kim H, Vaishampayan U. "PROBE"ing the Role of Cytoreductive Nephrectomy in Advanced Renal Cancer. Kidney Cancer J. 2022 Mar 15;6(1):3-9. doi: 10.3233/kca-210010.
PubMed 35310961Kuusk T, Abu-Ghanem Y, Mumtaz F, Powles T, Bex A. Perioperative therapy in renal cancer in the era of immune checkpoint inhibitor therapy. Curr Opin Urol. 2021 May 1;31(3):262-269. doi: 10.1097/MOU.0000000000000868.
PubMed 33742979
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Trial of Immunotherapy-Based Combination Therapy With or Without Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma (PROBE Trial)
- ClinicalTrials.gov ID
- NCT04510597
- Acronym / sponsor ID
- PROBE / S1931
- Conditions
- Metastatic Clear Cell Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 364 participants (estimated)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- Jul 2033 (estimated)
- Study completion
- Jul 2033 (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 III trial compares the effect of adding surgery to a standard of care immunotherapy-based drug combination versus a standard of care immunotherapy-based drug combination alone in treating patients with kidney cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, pembrolizumab, and avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Surgery to remove the kidney, called a nephrectomy, is also considered standard of care; however, doctors who treat kidney cancer do not agree on its benefits. It is not yet known if the addition of surgery to an immunotherapy-based drug combination works better than an immunotherapy-based drug combination alone in treating patients with kidney cancer.
Detailed description
PRIMARY OBJECTIVE:
- To compare overall survival in participants with newly diagnosed metastatic renal cell carcinoma who are randomized to receive immune checkpoint inhibitor-based combination treatment plus cytoreductive nephrectomy versus immune checkpoint inhibitor-based combination treatment alone.
SECONDARY OBJECTIVES:
- To compare overall survival between arms in the subset who received their assigned protocol treatment.
II. To assess complications of nephrectomy and post-randomization drug toxicities.
III. To compare objective response rate in metastatic sites between the arms in participants with measurable metastatic disease.
IV. To assess change in diameter of primary tumor at week 12 disease assessment in participants who have received pre-randomization treatment.
BANKING OBJECTIVE:
- To bank specimens for future correlative studies.
OUTLINE:
PRE-RANDOMIZATION TREATMENT: Treatment naive patients are assigned to 1 of 3 treatment regimens per standard of care.
REGIMEN I: Patients receive nivolumab intravenously (IV) and ipilimumab IV. Treatment repeats every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV on day 1. Cycles repeat every 2-4 weeks in the absence of disease progression or unacceptable toxicity.
REGIMEN II: Patients receive pembrolizumab IV on day 1 and axitinib orally (PO) twice daily (BID) on days 1-21. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
REGIMEN III: Patients receive avelumab IV on day 1 and axitinib PO BID on days 1-14. Cycles repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
NOTE: Some patients may have already completed the standard of care pre-randomization treatment specified above off-trial.
RANDOMIZATION TREATMENT: Between 10-14 weeks from the start of on-trial or off-trial pre-randomization treatment, patients are randomized to 1 of 2 arms.
ARM I: Patients receive nivolumab IV, pembrolizumab IV, or avelumab IV on day 1. Patients also receive axitinib PO BID. Cycles with nivolumab repeat every 2 or 4 weeks, cycles with pembrolizumab repeat every 3 weeks, and cycles with avelumab repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
ARM II: Within 42 days following randomization, patients undergo radical or partial nephrectomy in addition to nivolumab, pembrolizumab, avelumab, and axitinib as in Arm I in the absence of disease progression or unacceptable toxicity. Axitinib should be stopped at least 24 hours prior to surgery.
After completion of trial treatment, patients are followed up every 3 months for the first year, every 6 months for years 2 and 3, and then annually for up to 7 years from randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Continued Systemic Therapy Only | Active comparator | Procedure: Cytoreductive Nephrectomy, Drug: Active ComparatorNivolumab 240 mg IV 1 q 2 weeks OR Nivolumab 480 mg IV 1 q 4 weeks OR Pembrolizumab 200 mg IV 1 q 3 weeks Axitinib 5 mg oral Daily BID OR Avelumab 10 mg/kg IV 1 q 2 weeks Axitinib 5 mg oral Daily BID |
| Arm 2: Nephrectomy and Continued Systemic Therapy | Experimental | Procedure: Cytoreductive NephrectomyContinued systemic therapy as above, plus: Radical or partial nephrectomy may be performed using laparoscopic, open, or robotic approaches. Surgery should be performed within 8 weeks of randomization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- STEP 1 REGISTRATION: Participants must have a histologically proven diagnosis of clear cell or non-clear cell renal cell carcinoma. Participants with collecting duct carcinoma histology are not eligible. Participants with multifocal or bilateral tumors are eligible
- STEP 1 REGISTRATION: Participants must have primary tumor in place
- STEP 1 REGISTRATION: Participants must have the following scans performed, showing clinical evidence of measurable or non-measurable metastatic disease:
- Treatment naive participants must have scans documenting metastatic disease completed within 90 days prior to study registration
- Previously treated participants must have scans documenting metastatic disease completed within 90 days prior to first dose of systemic treatment
Key exclusion criteria (20 listed)
- STEP 1 REGISTRATION: Participants must not have known active brain metastases. Participants with previously treated brain metastases are eligible if participant has no neurologic signs or symptoms suggestive of brain metastasis. Brain imaging studies are not required. If brain imaging studies are performed, they must be negative for disease
- STEP 1 REGISTRATION: Participants must not have received the following prior treatment of metastatic renal cell carcinoma:
- STEP 1 REGISTRATION: Participants must not have received more than the following amounts protocol-directed pre-randomization treatment:
- STEP 1 REGISTRATION: Participants must not have received immunotherapy for any cancer within the following timeframes:
- STEP 1 REGISTRATION: Participants must not have a solitary kidney and not have a transplanted kidney
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 |
|---|---|---|
| Cytoreductive NephrectomyRadical or partial nephrectomy may be performed using laparoscopic, open, or robotic approaches. Surgery should be performed within 8 weeks of randomization | Procedure or surgery | Arm 1: Continued Systemic Therapy Only, Arm 2: Nephrectomy and Continued Systemic Therapy |
| Active ComparatorNivolumab 240 mg IV 1 q 2 weeks OR Nivolumab 480 mg IV 1 q 4 weeks OR Pembrolizumab 200 mg IV 1 q 3 weeks Axitinib 5 mg oral Daily BID OR Avelumab 10 mg/kg IV 1 q 2 weeks Axitinib 5 mg oral Daily BID | Drug | Arm 1: Continued Systemic Therapy Only |
Primary outcome
Overall survival
Time frame: From date of randomization to date of death due to any cause, assessed up to 7 years.
Analysis will be intent-to-treat. Evidence suggesting early termination of the trial and a conclusion that the cytoreductive nephrectomy (CN) approach is superior to treatment alone would be if the null hypothesis is rejected at the one-sided 0.005 level. For the second and third interim analyses, the null and alternative hypotheses with respect to survival will be tested, with superiority tested at the one-sided 0.005 level, and futility determined to be met if the (CN versus no CN) hazard ratio is greater than or equal to 1. A proportional hazards model will be fit to estimate the hazard ratio adjusting for the stratification factors as covariates in the model. Will evaluate whether each of the stratification factors are predictive factors of cytoreductive nephrectomy by placing an interaction term corresponding to each stratification factor and treatment arm in the proportional hazards survival model.
4 secondary outcomes
Overall survival in subset who received assigned protocol treatment
Time frame: From date of randomization to date of death due to any cause, assessed up to 7 years
Progression-free survival
Time frame: From date of randomization to date of first documentation of progression, or death due to any cause, assessed up to 7 years
Objective response
Time frame: Up to 7 years
Change in maximum diameter of primary tumor
Time frame: From the disease assessment just prior to the start of immunotherapy to the week 12 disease assessment
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 8 Oct 2026.
- Derived from this study: PubMed 35310961Bell H, Cotta BH, Salami SS, Kim H, Vaishampayan U. "PROBE"ing the Role of Cytoreductive Nephrectomy in Advanced Renal Cancer. Kidney Cancer J. 2022 Mar 15;6(1):3-9. doi: 10.3233/kca-210010.
- Derived from this study: PubMed 33742979Kuusk T, Abu-Ghanem Y, Mumtaz F, Powles T, Bex A. Perioperative therapy in renal cancer in the era of immune checkpoint inhibitor therapy. Curr Opin Urol. 2021 May 1;31(3):262-269. doi: 10.1097/MOU.0000000000000868.
- Individual participant dataSharing planned: No
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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.
387 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 Cytoreductive Nephrectomy and Active Comparator in people with Metastatic Clear Cell Renal Cell Carcinoma and Metastatic Renal Cell Carcinoma, run by SWOG Cancer Research Network at 387 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 33 inclusion and 20 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 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 387 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 Megan Keim, MS (210-614-8808, mkeim@swog.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: From date of randomization to date of death due to any cause, assessed up to 7 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04510597, which also lists 2 linked publications.
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 8 Oct 2026.