Comparing the Outcome of Immunotherapy-Based Drug Combination Therapy With or Without Surgery to Remove the Kidney in Metastatic Kidney Cancer, the PROBE Trial
PROBE
Phase III Trial of Immunotherapy-Based Combination Therapy With or Without Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma (PROBE Trial)
2 other identifiers
interventional
364
1 country
387
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2021
Longer than P75 for phase_3
387 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2020
CompletedFirst Posted
Study publicly available on registry
August 12, 2020
CompletedStudy Start
First participant enrolled
March 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2033
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2033
September 9, 2025
September 1, 2025
12.3 years
August 10, 2020
September 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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
From date of randomization to date of death due to any cause, assessed up to 7 years
Progression-free survival
From date of randomization to date of first documentation of progression, or death due to any cause, assessed up to 7 years
Objective response
Up to 7 years
Change in maximum diameter of primary tumor
From the disease assessment just prior to the start of immunotherapy to the week 12 disease assessment
Study Arms (2)
Arm 1: Continued Systemic Therapy Only
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
EXPERIMENTALContinued 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.
Interventions
Radical or partial nephrectomy may be performed using laparoscopic, open, or robotic approaches. Surgery should be performed within 8 weeks of randomization
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
Eligibility Criteria
You may qualify if:
- 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:
- 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)
- +18 more criteria
You may not qualify if:
- 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.
- 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:
- infusions of nivolumab
- infusions of ipilimumab
- infusions of pembrolizumab
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SWOG Cancer Research Networklead
- National Cancer Institute (NCI)collaborator
Study Sites (387)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Kingman Regional Medical Center
Kingman, Arizona, 86401, United States
Banner University Medical Center - Tucson
Tucson, Arizona, 85719, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903, United States
PCR Oncology
Arroyo Grande, California, 93420, United States
Sutter Auburn Faith Hospital
Auburn, California, 95602, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, 95603, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704, United States
Keck Medicine of USC Buena Park
Buena Park, California, 90621, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, 95682, United States
Eden Hospital Medical Center
Castro Valley, California, 94546, United States
Sutter Davis Hospital
Davis, California, 95616, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
Palo Alto Medical Foundation-Fremont
Fremont, California, 94538, United States
Keck Medicine of USC Huntington Beach
Huntington Beach, California, 92648, United States
Keck Medicine of USC Koreatown
Los Angeles, California, 90020, United States
Los Angeles County-USC Medical Center
Los Angeles, California, 90033, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
Memorial Medical Center
Modesto, California, 95355, United States
Palo Alto Medical Foundation-Camino Division
Mountain View, California, 94040, United States
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, 94040, United States
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, 92663, United States
Sutter Cancer Research Consortium
Novato, California, 94945, United States
Palo Alto Medical Foundation Health Care
Palo Alto, California, 94301, United States
Keck Medical Center of USC Pasadena
Pasadena, California, 91105, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, 95661, United States
Sutter Roseville Medical Center
Roseville, California, 95661, United States
Sutter Medical Center Sacramento
Sacramento, California, 95816, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, 94115, United States
Mills Health Center
San Mateo, California, 94401, United States
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California, 95065, United States
Sutter Pacific Medical Foundation
Santa Rosa, California, 95403, United States
City of Hope South Pasadena
South Pasadena, California, 91030, United States
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, 94086, United States
Cedars-Sinai Cancer - Tarzana
Tarzana, California, 91356, United States
City of Hope Upland
Upland, California, 91786, United States
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville, California, 95687, United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California, 94589, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
AdventHealth Altamonte
Altamonte Springs, Florida, 32701, United States
AdventHealth Celebration
Celebration, Florida, 34747, United States
AdventHealth Kissimmee
Kissimmee, Florida, 34744, United States
AdventHealth Medical Group Urology at Orlando
Orlando, Florida, 32803, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
Orlando Health Cancer Institute
Orlando, Florida, 32806, United States
AdventHealth East Orlando
Orlando, Florida, 32822, United States
AdventHealth Winter Park
Winter Park, Florida, 32792, United States
Saint Anthony's Health
Alton, Illinois, 62002, United States
Rush - Copley Medical Center
Aurora, Illinois, 60504, United States
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704, United States
Loyola Center for Health at Burr Ridge
Burr Ridge, Illinois, 60527, United States
Illinois CancerCare-Canton
Canton, Illinois, 61520, United States
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902, United States
SIH Cancer Institute
Carterville, Illinois, 62918, United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321, United States
Centralia Oncology Clinic
Centralia, Illinois, 62801, United States
Saint Mary's Hospital
Centralia, Illinois, 62801, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Illinois
Chicago, Illinois, 60612, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657, United States
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, 60014, United States
Carle at The Riverfront
Danville, Illinois, 61832, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115, United States
Illinois CancerCare-Dixon
Dixon, Illinois, 61021, United States
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515, United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Advocate Sherman Hospital
Elgin, Illinois, 60123, United States
Elmhurst Memorial Hospital
Elmhurst, Illinois, 60126, United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401, United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134, United States
Advocate South Suburban Hospital
Hazel Crest, Illinois, 60429, United States
Loyola Medicine Homer Glen
Homer Glen, Illinois, 60491, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443, United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045, United States
AMG Libertyville - Oncology
Libertyville, Illinois, 60048, United States
Condell Memorial Hospital
Libertyville, Illinois, 60048, United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
Melrose Park, Illinois, 60160, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864, United States
Edward Hospital/Cancer Center
Naperville, Illinois, 60540, United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, 60451, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453-2699, United States
University of Chicago Medicine-Orland Park
Orland Park, Illinois, 60462, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068, United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
Illinois CancerCare-Peru
Peru, Illinois, 61354, United States
Valley Radiation Oncology
Peru, Illinois, 61354, United States
Edward Hospital/Cancer Center?Plainfield
Plainfield, Illinois, 60585, United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Springfield Clinic
Springfield, Illinois, 62702, United States
Memorial Medical Center
Springfield, Illinois, 62781, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
The Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555, United States
Illinois CancerCare - Washington
Washington, Illinois, 61571, United States
Rush-Copley Healthcare Center
Yorkville, Illinois, 60560, United States
Reid Health
Richmond, Indiana, 47374, United States
Mary Greeley Medical Center
Ames, Iowa, 50010, United States
McFarland Clinic - Ames
Ames, Iowa, 50010, United States
McFarland Clinic - Boone
Boone, Iowa, 50036, United States
Saint Anthony Regional Hospital
Carroll, Iowa, 51401, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309, United States
Broadlawns Medical Center
Des Moines, Iowa, 50314, United States
Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501, United States
Trinity Regional Medical Center
Fort Dodge, Iowa, 50501, United States
McFarland Clinic - Jefferson
Jefferson, Iowa, 50129, United States
McFarland Clinic - Marshalltown
Marshalltown, Iowa, 50158, United States
Methodist West Hospital
West Des Moines, Iowa, 50266-7700, United States
Central Care Cancer Center - Garden City
Garden City, Kansas, 67846, United States
Central Care Cancer Center - Great Bend
Great Bend, Kansas, 67530, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536, United States
Hematology/Oncology Clinic PLLC
Baton Rouge, Louisiana, 70809, United States
East Jefferson General Hospital
Metairie, Louisiana, 70006, United States
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie, Louisiana, 70006, United States
Louisiana State University Health Science Center
New Orleans, Louisiana, 70112, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Bronson Battle Creek
Battle Creek, Michigan, 49017, United States
University of Michigan - Brighton Center for Specialty Care
Brighton, Michigan, 48116, United States
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, 48183, United States
Henry Ford Hematology Oncology - Hayes
Clinton Township, Michigan, 48038, United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038, United States
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, 48126, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, 49503, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503, United States
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503, United States
Allegiance Health
Jackson, Michigan, 49201, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Ascension Borgess Cancer Center
Kalamazoo, Michigan, 49009, United States
Borgess Medical Center
Kalamazoo, Michigan, 49048, United States
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444, United States
Lakeland Hospital Niles
Niles, Michigan, 49120, United States
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, 49444, United States
Henry Ford Medical Center-Columbus
Novi, Michigan, 48377, United States
Spectrum Health Reed City Hospital
Reed City, Michigan, 49677, United States
Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan, 49085, United States
Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085, United States
Henry Ford Macomb Health Center - Shelby Township
Shelby, Michigan, 48315, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322, United States
Henry Ford Wyandotte Hospital
Wyandotte, Michigan, 48192, United States
University of Michigan Health - West
Wyoming, Michigan, 49519, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337, United States
Cambridge Medical Center
Cambridge, Minnesota, 55008, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Unity Hospital
Fridley, Minnesota, 55432, United States
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Health Partners Inc
Minneapolis, Minnesota, 55454, United States
Monticello Cancer Center
Monticello, Minnesota, 55362, United States
New Ulm Medical Center
New Ulm, Minnesota, 56073, United States
Fairview Northland Medical Center
Princeton, Minnesota, 55371, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
Fairview Lakes Medical Center
Wyoming, Minnesota, 55092, United States
Gulfport Memorial Hospital
Gulfport, Mississippi, 39502, United States
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri, 63011, United States
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613, United States
Cox Cancer Center Branson
Branson, Missouri, 65616, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Southeast Cancer Center
Cape Girardeau, Missouri, 63703, United States
Parkland Health Center - Farmington
Farmington, Missouri, 63640, United States
Capital Region Southwest Campus
Jefferson City, Missouri, 65109, United States
Freeman Health System
Joplin, Missouri, 64804, United States
Mercy Hospital Joplin
Joplin, Missouri, 64804, United States
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, 65401, United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506, United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
Saint Louis Cancer and Breast Institute-South City
St Louis, Missouri, 63109, United States
Mercy Hospital South
St Louis, Missouri, 63128, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080, United States
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri, 63127, United States
Mercy Hospital Washington
Washington, Missouri, 63090, United States
Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
Omaha, Nebraska, 68114, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Oncology Associates PC
Omaha, Nebraska, 68114, United States
Carson Tahoe Regional Medical Center
Carson City, Nevada, 89703, United States
Cancer and Blood Specialists-Henderson
Henderson, Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson, Nevada, 89052, United States
Las Vegas Cancer Center-Henderson
Henderson, Nevada, 89052, United States
OptumCare Cancer Care at Seven Hills
Henderson, Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada, 89074, United States
GenesisCare USA - Henderson
Henderson, Nevada, 89074, United States
Las Vegas Urology - Green Valley
Henderson, Nevada, 89074, United States
Las Vegas Urology - Pebble
Henderson, Nevada, 89074, United States
Urology Specialists of Nevada - Green Valley
Henderson, Nevada, 89074, United States
Las Vegas Urology - Pecos
Las Vegas, Nevada, 89074, United States
Desert West Surgery
Las Vegas, Nevada, 89102, United States
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, 89102, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
Hope Cancer Care of Nevada
Las Vegas, Nevada, 89103, United States
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, 89106, United States
Urology Specialists of Nevada - Central
Las Vegas, Nevada, 89106, United States
GenesisCare USA - Las Vegas
Las Vegas, Nevada, 89109, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109, United States
Las Vegas Prostate Cancer Center
Las Vegas, Nevada, 89113, United States
Las Vegas Urology - Sunset
Las Vegas, Nevada, 89113, United States
Urology Specialists of Nevada - Southwest
Las Vegas, Nevada, 89113, United States
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada, 89119, United States
Ann M Wierman MD LTD
Las Vegas, Nevada, 89128, United States
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada, 89128, United States
GenesisCare USA - Vegas Tenaya
Las Vegas, Nevada, 89128, United States
Las Vegas Urology - Cathedral Rock
Las Vegas, Nevada, 89128, United States
Las Vegas Urology - Smoke Ranch
Las Vegas, Nevada, 89128, United States
OptumCare Cancer Care at MountainView
Las Vegas, Nevada, 89128, United States
Urology Specialists of Nevada - Northwest
Las Vegas, Nevada, 89128, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135, United States
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada, 89144, United States
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada, 89144, United States
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144, United States
Las Vegas Cancer Center-Medical Center
Las Vegas, Nevada, 89148-2405, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148, United States
GenesisCare USA - Fort Apache
Las Vegas, Nevada, 89148, United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89148, United States
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, 89169, United States
University Cancer Center
Las Vegas, Nevada, 89169, United States
Hope Cancer Care of Nevada-Pahrump
Pahrump, Nevada, 89048, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Saint Mary's Regional Medical Center
Reno, Nevada, 89503, United States
Radiation Oncology Associates
Reno, Nevada, 89509, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042, United States
University of Rochester
Rochester, New York, 14642, United States
Phelps Memorial Hospital Center
Sleepy Hollow, New York, 10591, United States
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, 28328, United States
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, 27534, United States
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, 28546, United States
UH Seidman Cancer Center at UH Avon Health Center
Avon, Ohio, 44011, United States
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122, United States
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431, United States
Saint Elizabeth Boardman Hospital
Boardman, Ohio, 44512, United States
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459, United States
Miami Valley Hospital South
Centerville, Ohio, 45459, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219, United States
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Dayton Physician LLC-Miami Valley Hospital North
Dayton, Ohio, 45415, United States
Miami Valley Hospital North
Dayton, Ohio, 45415, United States
Armes Family Cancer Center
Findlay, Ohio, 45840, United States
Blanchard Valley Hospital
Findlay, Ohio, 45840, United States
Orion Cancer Care
Findlay, Ohio, 45840, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Dayton Physicians LLC-Atrium
Franklin, Ohio, 45005, United States
Dayton Physicians LLC-Wayne
Greenville, Ohio, 45331, United States
Wayne Hospital
Greenville, Ohio, 45331, United States
Greater Dayton Cancer Center
Kettering, Ohio, 45409, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, 44060, United States
Springfield Regional Cancer Center
Springfield, Ohio, 45504, United States
Springfield Regional Medical Center
Springfield, Ohio, 45505, United States
University of Toledo
Toledo, Ohio, 43614, United States
Dayton Physicians LLC - Troy
Troy, Ohio, 45373, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
Saint Joseph Warren Hospital
Warren, Ohio, 44484, United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069, United States
Saint Elizabeth Youngstown Hospital
Youngstown, Ohio, 44501, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120, United States
Kaiser Sunnyside Medical Center
Clackamas, Oregon, 97015, United States
Rogue Valley Medical Center
Medford, Oregon, 97504, United States
Kaiser Permanente Northwest
Portland, Oregon, 97227, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
UPMC Altoona
Altoona, Pennsylvania, 16601, United States
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania, 15009, United States
UPMC Hillman Cancer Center at Butler Health System
Butler, Pennsylvania, 16001, United States
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, 16505, United States
UPMC Cancer Center at UPMC Horizon
Farrell, Pennsylvania, 16121, United States
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, 15601, United States
IRMC Cancer Center
Indiana, Pennsylvania, 15701, United States
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania, 15901, United States
UPMC Cancer Center at UPMC McKeesport
McKeesport, Pennsylvania, 15132, United States
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania, 15146, United States
UPMC Hillman Cancer Center - Part of Frick Hospital
Mount Pleasant, Pennsylvania, 15666, United States
Arnold Palmer Cancer Center Medical Oncology Norwin
N. Huntingdon, Pennsylvania, 15642, United States
UPMC Cancer Center-Natrona Heights
Natrona Heights, Pennsylvania, 15065, United States
UPMC Hillman Cancer Center - New Castle
New Castle, Pennsylvania, 16105, United States
UPMC-Saint Margaret
Pittsburgh, Pennsylvania, 15215, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232, United States
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, 15232, United States
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, 15237, United States
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania, 15243, United States
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania, 16346, United States
UPMC Cancer Center-Uniontown
Uniontown, Pennsylvania, 15401, United States
UPMC Cancer Center-Washington
Washington, Pennsylvania, 15301, United States
UPMC West Mifflin-Cancer Center Jefferson
West Mifflin, Pennsylvania, 15122, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640, United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615, United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672, United States
UT Southwestern Simmons Cancer Center - RedBird
Dallas, Texas, 75237, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas, 76104, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030, United States
Ben Taub General Hospital
Houston, Texas, 77030, United States
UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas, 75080, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
University of Utah Sugarhouse Health Center
Salt Lake City, Utah, 84106, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
George E Wahlen Department of Veterans Affairs Medical Center
Salt Lake City, Utah, 84148, United States
Norris Cotton Cancer Center-North
Saint Johnsbury, Vermont, 05819, United States
Overlake Medical Center
Bellevue, Washington, 98004, United States
Valley Medical Center
Renton, Washington, 98055, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, 98902, United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105, United States
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, 54729, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701, United States
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142, United States
Marshfield Clinic - Ladysmith Center
Ladysmith, Wisconsin, 54848, United States
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051, United States
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, 53209, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233, United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, 54548, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017, United States
Drexel Town Square Health Center
Oak Creek, Wisconsin, 53154, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904, United States
Aurora Cancer Care-Racine
Racine, Wisconsin, 53406, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868, United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081, United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482, United States
Aurora Medical Center in Summit
Summit, Wisconsin, 53066, United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, 54241, United States
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, 54401, United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, 53226, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227, United States
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, 53095, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, 54494, United States
Related Publications (2)
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.
PMID: 35310961DERIVEDKuusk 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.
PMID: 33742979DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2020
First Posted
August 12, 2020
Study Start
March 8, 2021
Primary Completion (Estimated)
July 1, 2033
Study Completion (Estimated)
July 1, 2033
Last Updated
September 9, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share