Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing Nephrectomy
A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients With Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)
3 other identifiers
interventional
819
3 countries
413
Brief Summary
This phase III trial compares nephrectomy (surgery to remove a kidney or part of a kidney) with nivolumab to the usual approach of nephrectomy followed by standard post-operative follow-up and monitoring, in treating patients with kidney cancer that is limited to a certain part of the body (localized). Nivolumab is a drug that may help stimulate the immune system to attack any cancer cells that may remain after surgery. The addition of nivolumab to the usual surgery could prevent the cancer from returning. It is not yet known whether nivolumab and nephrectomy is more effective than nephrectomy 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 P75+ for phase_3
Started Apr 2017
Longer than P75 for phase_3
413 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
February 15, 2017
CompletedFirst Posted
Study publicly available on registry
February 16, 2017
CompletedStudy Start
First participant enrolled
April 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2023
CompletedResults Posted
Study results publicly available
April 25, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 9, 2031
ExpectedMay 4, 2026
January 1, 2026
6.1 years
February 15, 2017
February 6, 2024
May 1, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Recurrence-free Survival (RFS) Rate at 5 Years
RFS is defined as time from randomization to disease recurrence or death from any cause. Patients who did not undergo nephrectomy or were not disease-free following nephrectomy were considered as having an event at day 1. Patients that are alive without an event were censored at the date of last disease evaluation. RFS rate at 5 years was the proportion of patients who are recurrence-free and alive at 5 years based on Kaplan-Meier estimates.
Assessed at 20 weeks, 40 weeks, then every 3 months for patients <2 years from randomization, then every 6 months for 3 years
Secondary Outcomes (2)
Recurrence-free Survival (RFS) Rate at 3 Years Among Patients With Clear Cell Histology
Assessed at 20 weeks, 40 weeks, then every 3 months for patients <2 years from randomization, then every 6 months for 1 year
Overall Survival Rate at 5 Years
Assessed at 20 weeks, 40 weeks, then every 3 months for patients <2 years from randomization, then every 6 months for 3 years
Other Outcomes (9)
Association Between the Primary Tumor's Expression of PD-L1 With Outcome
Assessed at 20 weeks, 40 weeks, then every 3 months for patients <2 years from randomization, then every 6 months for 3 years, then annually for 5 years
Association Between the Expression of PD-L1 on Tumor Tissue at Nephrectomy as Well as Recurrence and Outcome
Assessed at 20 weeks, 40 weeks, then every 3 months for patients <2 years from randomization, then every 6 months for 3 years, then annually for 5 years
To Archive Images for Potential Central Confirmation of Recurrence and for Future Correlative Work
Assessed at 20 weeks, 40 weeks, then every 3 months for patients <2 years from randomization, then every 6 months for 3 years, then annually for 5 years
- +6 more other outcomes
Study Arms (2)
Arm A (nivolumab + nephrectomy)
EXPERIMENTALPatients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 2 cycles. Patients then undergo partial or radical nephrectomy 7-28 days later. Patients then receive nivolumab over 30 IV on day 1. Treatment repeats every 14 days for 6 cycles, and then every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients enrolled after Amendment 4 receive nivolumab IV over 30 minutes on day 1. Patients then undergo partial or radical nephrectomy 7-28 days later. Patient then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 4 weeks for up to 9 cycles in the absence of disease progression or unacceptable toxicity.
Arm B (nephrectomy only)
ACTIVE COMPARATORPatients undergo partial or radical nephrectomy within 8 weeks after registration followed by observation.
Interventions
Ancillary studies
Given IV
Undergo observation
Ancillary studies
Eligibility Criteria
You may qualify if:
- ELIGIBILITY CRITERIA FOR RANDOMIZATION:
- Patients must have a renal mass consistent with a clinical stage \>= T2Nx renal cell carcinoma (RCC) or TanyN+ RCC for which radical or partial nephrectomy is planned
- Patients must have no clinical or radiological evidence of distant metastases (M0) unless the presumed M1 disease is planned to be resected/definitively treated (e.g., thermal ablation, stereotactic radiation) at the same time or up to 12 weeks after the date of the initial procedure such that the patient is considered "no evidence of disease" (M1 NED)
- Liver, bone, or brain metastases are not permitted
- No more than 3 metastases are permitted, and all must be able to be removed or definitively treated within 12 weeks of the primary tumor resection
- If histological confirmation of RCC has not been done within 12 months prior to randomization, patient must be willing to undergo a core biopsy for this purpose if randomized to Arm A
- NOTE: This histologic confirmation can be a (1) standard of care diagnostic biopsy or (2) a research biopsy or a planned metastasectomy. Tissue must be obtained with results available prior to the neoadjuvant dose
- Patients randomized to Arm A: core tumor biopsy must have demonstrated RCC of any histology, including sarcomatoid, unclassified, or "unknown histology" (if preoperative biopsy was uninformative) with exception below for non-diagnostic biopsies
- If the biopsy performed following randomization clearly demonstrates a benign condition, oncocytoma or a different type of cancer that is not RCC, the patient is not eligible and must come off study
- A non-diagnostic biopsy is considered a good faith effort and does not need to be repeated unless deemed clinically necessary by the treating investigator
- Patient must not have any prior systemic or local anti-cancer therapy for the current RCC
- Patient must not have undergone a partial nephrectomy for the current RCC
- Patient must not have had a metastasectomy for the current RCC diagnosis unless performed to render patient NED (in addition to the planned nephrectomy) within 6 months prior to the current diagnosis
- Patient must not have received current or past antineoplastic systemic therapies for RCC: i.e., chemotherapy, hormonal therapy, immunotherapy, or standard or investigational agents for treatment of RCC
- Patient must not have received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- +38 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)lead
- Canadian Cancer Trials Groupcollaborator
Study Sites (413)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
Veterans Administration Medical Center - Birmingham
Birmingham, Alabama, 35233, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Cancer Center at Saint Joseph's
Phoenix, Arizona, 85004, United States
Banner University Medical Center - Tucson
Tucson, Arizona, 85719, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719, United States
Kaiser Permanente-Anaheim
Anaheim, California, 92806, United States
Sutter Auburn Faith Hospital
Auburn, California, 95602, United States
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield, California, 93301, United States
Kaiser Permanente-Baldwin Park
Baldwin Park, California, 91706, United States
Kaiser Permanente-Bellflower
Bellflower, California, 90706, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704, United States
Mills-Peninsula Medical Center
Burlingame, California, 94010, United States
Community Cancer Institute
Clovis, California, 93611, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
Kaiser Permanente-Fontana
Fontana, California, 92335, United States
Kaiser Permanente South Bay
Harbor City, California, 90710, United States
Kaiser Permanente-Irvine
Irvine, California, 92618, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Kaiser Permanente West Los Angeles
Los Angeles, California, 90034, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
Fremont - Rideout Cancer Center
Marysville, California, 95901, United States
Palo Alto Medical Foundation-Camino Division
Mountain View, California, 94040, United States
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, 92663, United States
Kaiser Permanente-Oakland
Oakland, California, 94611, United States
Kaiser Permanente-Ontario
Ontario, California, 91761, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
Palo Alto Medical Foundation Health Care
Palo Alto, California, 94301, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304, United States
VA Palo Alto Health Care System
Palo Alto, California, 94304, United States
Kaiser Permanente - Panorama City
Panorama City, California, 91402, United States
Eisenhower Medical Center
Rancho Mirage, California, 92270, United States
Kaiser Permanente-Riverside
Riverside, California, 92505, United States
Kaiser Permanente-Roseville
Roseville, California, 95661, United States
Sutter Roseville Medical Center
Roseville, California, 95661, United States
Kaiser Permanente Downtown Commons
Sacramento, California, 95814, United States
Sutter Medical Center Sacramento
Sacramento, California, 95816, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
Kaiser Permanente Sacramento Medical Center
Sacramento, California, 95825, United States
Kaiser Permanente-San Diego Zion
San Diego, California, 92120, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, 94115, United States
Kaiser Permanente-San Francisco
San Francisco, California, 94115, United States
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, 95119, United States
Kaiser Permanente San Leandro
San Leandro, California, 94577, United States
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California, 93401, United States
Kaiser Permanente-San Marcos
San Marcos, California, 92078, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051, United States
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California, 95065, United States
Kaiser Permanente-South San Francisco
South San Francisco, California, 94080, United States
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, 94086, United States
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California, 96161, United States
Kaiser Permanente-Vallejo
Vallejo, California, 94589, United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California, 94589, United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California, 94596, United States
Presbyterian Intercommunity Hospital
Whittier, California, 90602, United States
Kaiser Permanente-Woodland Hills
Woodland Hills, California, 91367, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909, United States
Memorial Hospital North
Colorado Springs, Colorado, 80920, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, 80528, United States
UCHealth Greeley Hospital
Greeley, Colorado, 80631, United States
Medical Center of the Rockies
Loveland, Colorado, 80538, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Midstate Medical Center
Meriden, Connecticut, 06451, United States
The Hospital of Central Connecticut
New Britain, Connecticut, 06050, United States
Yale University
New Haven, Connecticut, 06520, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, 06360, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
George Washington University Medical Center
Washington D.C., District of Columbia, 20037, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, 33146, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
UF Health Cancer Institute - Gainesville
Gainesville, Florida, 32610, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207, United States
Lakeland Regional Health Hollis Cancer Center
Lakeland, Florida, 33805, United States
The Watson Clinic
Lakeland, Florida, 33805, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
Miami Cancer Institute
Miami, Florida, 33176, United States
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, 33176, United States
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, 33324, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Atlanta VA Medical Center
Decatur, Georgia, 30033, United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813, United States
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii, 96813, United States
Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Straub Clinic and Hospital
Honolulu, Hawaii, 96813, United States
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, 96817, United States
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, 96701, United States
Pali Momi Medical Center
‘Aiea, Hawaii, 96701, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712, United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814, United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619, United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642, United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83687, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854, United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, 83864, United States
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, 83301, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704, United States
Illinois CancerCare-Canton
Canton, Illinois, 61520, United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush MD Anderson Cancer 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
Carle at The Riverfront
Danville, Illinois, 61832, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526, United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, 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
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134, United States
Edward Hines Jr VA Hospital
Hines, Illinois, 60141, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443, 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
Edward Hospital/Cancer Center
Naperville, Illinois, 60540, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Illinois CancerCare-Peru
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
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
Parkview Regional Medical Center
Fort Wayne, Indiana, 46845, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, 46202, United States
Franciscan Health Indianapolis
Indianapolis, Indiana, 46237, United States
Woodland Cancer Care Center
Michigan City, Indiana, 46360, United States
Franciscan Health Mooresville
Mooresville, Indiana, 46158, United States
Reid Health
Richmond, Indiana, 47374, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, 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
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314, United States
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501, United States
McFarland Clinic - Jefferson
Jefferson, Iowa, 50129, United States
McFarland Clinic - Marshalltown
Marshalltown, Iowa, 50158, United States
Mercy Medical Center-West Lakes
West Des Moines, Iowa, 50266, United States
HaysMed
Hays, Kansas, 67601, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
The University of Kansas Cancer Center - Olathe
Olathe, Kansas, 66061, United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210, United States
Mercy Hospital Pittsburg
Pittsburg, Kansas, 66762, United States
Salina Regional Health Center
Salina, Kansas, 67401, United States
Cotton O'Neil Cancer Center / Stormont Vail Health
Topeka, Kansas, 66606, United States
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, 66606, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536, United States
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, 70805, United States
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, 70808, United States
Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana, 70809, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
Northshore Oncology Associates-Covington
Covington, Louisiana, 70433, United States
Oncology Center of The South Incorporated
Houma, Louisiana, 70360, 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 School of Medicine
New Orleans, Louisiana, 70112, United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121, United States
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, 71103, United States
Harold Alfond Center for Cancer Care
Augusta, Maine, 04330, United States
Eastern Maine Medical Center
Bangor, Maine, 04401, United States
MaineHealth Waldo Hospital
Belfast, Maine, 04915, United States
MaineHealth Maine Medical Center - Biddeford
Biddeford, Maine, 04005, United States
Lafayette Family Cancer Center-EMMC
Brewer, Maine, 04412, United States
Penobscot Bay Medical Center
Rockport, Maine, 04856, United States
MaineHealth Cancer Care and IV Therapy - Sanford
Sanford, Maine, 04073, United States
MaineHealth Cancer Care and IV Therapy - South Portland
South Portland, Maine, 04106, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
Beverly Hospital
Beverly, Massachusetts, 01915, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805, United States
Simonds-Sinon Regional Cancer Center
Fitchburg, Massachusetts, 01420, United States
Beth Israel Deaconess Medical Center/Winchester Center for Cancer Care
Winchester, Massachusetts, 01890, United States
UMass Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109, United States
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114, United States
Trinity Health Medical Center - Canton
Canton, Michigan, 48188, United States
Chelsea Hospital
Chelsea, Michigan, 48118, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503, United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912, United States
Henry Ford Health Providence Novi Hospital
Novi, Michigan, 48374, United States
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073, United States
Henry Ford Health Providence Southfield Hospital
Southfield, Michigan, 48075, United States
Corewell Health Beaumont Troy Hospital
Troy, Michigan, 48085, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Minneapolis VA Medical Center
Minneapolis, Minnesota, 55417, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, 56303, United States
Gulfport Memorial Hospital
Gulfport, Mississippi, 39502, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Saint Luke's Hospital
Chesterfield, Missouri, 63017, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376, United States
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri, 65212, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141, United States
University Health Truman Medical Center
Kansas City, Missouri, 64108, United States
University of Kansas Cancer Center - North
Kansas City, Missouri, 64154, United States
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Nebraska Cancer Specialists/Oncology Hematology West PC
Grand Island, Nebraska, 68803, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, 89102, United States
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada, 89144, United States
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, 89169, United States
University Cancer Center
Las Vegas, Nevada, 89169, United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89183, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, 08876, United States
Albany Medical Center
Albany, New York, 12208, United States
Glens Falls Hospital
Glens Falls, New York, 12801, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016, United States
NYP/Weill Cornell Medical Center
New York, New York, 10065, United States
University of Rochester
Rochester, New York, 14642, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461, United States
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, 10461, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467, United States
James J Peters VA Medical Center
The Bronx, New York, 10468, United States
Dickstein Cancer Treatment Center
White Plains, New York, 10601, United States
UNC Health Cancer Care Cary
Cary, North Carolina, 27518, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, 28328, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, 27534, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534, United States
Onslow Memorial Hospital
Jacksonville, North Carolina, 28546, United States
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, 28546, United States
ECU Health Oncology Kenansville
Kenansville, North Carolina, 28349, United States
ECU Health Oncology Kinston
Kinston, North Carolina, 28501, United States
Rex Hematology Oncology Associates-Blue Ridge
Raleigh, North Carolina, 27607, United States
UNC Health Cancer Care Raleigh
Raleigh, North Carolina, 27607, United States
UNC Health Cancer Care Wakefield
Raleigh, North Carolina, 27614, United States
ECU Health Oncology Richlands
Richlands, North Carolina, 28574, United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
Summa Health System - Akron Campus
Akron, Ohio, 44304, United States
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122, United States
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219, United States
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220, United States
Bethesda North Hospital
Cincinnati, Ohio, 45242, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Dayton Physicians LLC-Atrium
Franklin, Ohio, 45005, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
UH Seidman Cancer Center at Southwest General Hospital
Middleburg Heights, Ohio, 44130, United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, 43623, United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069, United States
UH Seidman Cancer Center at Saint John Medical Center
Westlake, Ohio, 44145, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120, United States
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015, United States
Asante Rogue Regional Medical Center
Medford, Oregon, 97504, United States
Providence Newberg Medical Center
Newberg, Oregon, 97132, United States
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225, United States
Kaiser Permanente Northwest
Portland, Oregon, 97227, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232, United States
Reading Hospital
West Reading, Pennsylvania, 19611, United States
UPMC Susquehanna
Williamsport, Pennsylvania, 17701, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Miriam Hospital
Providence, Rhode Island, 02906, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316, United States
Ralph H Johnson VA Medical Center
Charleston, South Carolina, 29401, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Prisma Health Cancer Institute - Laurens
Clinton, South Carolina, 29325, United States
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640, United States
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341, United States
Saint Francis Hospital
Greenville, South Carolina, 29601, United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605, United States
Saint Francis Cancer Center
Greenville, South Carolina, 29607, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615, United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
Lexington Medical Center
West Columbia, South Carolina, 29169, United States
Meharry Medical College
Nashville, Tennessee, 37208, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, 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
University of Texas Medical Branch
Galveston, Texas, 77555-0565, 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
UTMB Cancer Center at Victory Lakes
League City, Texas, 77573, United States
UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas, 75080, United States
Audie L Murphy VA Hospital
San Antonio, Texas, 78229, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Farmington Health Center
Farmington, Utah, 84025, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
South Jordan Health Center
South Jordan, Utah, 84009, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
University of Vermont and State Agricultural College
Burlington, Vermont, 05405, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
Sovah Health Martinsville
Martinsville, Virginia, 24112, United States
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia, 23116, United States
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, 23114, United States
Bon Secours Saint Mary's Hospital
Richmond, Virginia, 23226, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
University of Washington Medical Center - Montlake
Seattle, Washington, 98195, United States
Saint Michael Cancer Center
Silverdale, Washington, 98383, United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409, United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911, United States
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Brookfield, Wisconsin, 53045, United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701, United States
Aurora Health Center-Fond du Lac
Fond du Lac, Wisconsin, 54937, United States
Ascension Saint Francis - Reiman Cancer Center
Franklin, Wisconsin, 53132, 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
University of Wisconsin Carbone Cancer Center - Johnson Creek
Johnson Creek, Wisconsin, 53038, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142, United States
William S Middleton VA Medical Center
Madison, Wisconsin, 53705, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792, United States
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
Aspirus Medford Hospital
Medford, Wisconsin, 54451, 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 Medical Center - Minocqua
Minocqua, Wisconsin, 54548, United States
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149, United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066, 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
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188, United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401, United States
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, 54401, United States
Ascension Medical Group Southeast Wisconsin - Mayfair Road
Wauwatosa, Wisconsin, 53226, United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, 53226, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476, United States
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494, United States
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
The Moncton Hospital
Moncton, New Brunswick, E1C 6Z8, Canada
QEII Health Sciences Centre/Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 2Y9, Canada
Saint Joseph's Healthcare Charlton Campus
Hamilton, Ontario, L8N 4A6, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2, Canada
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7, Canada
London Regional Cancer Program
London, Ontario, N6A 4L6, Canada
Niagara Health System-Saint Catharines General
Saint Catharines, Ontario, L2S 0A9, Canada
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
University Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3, Canada
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4, Canada
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec, J1H 5N4, Canada
Rambam Medical Center
Haifa, 31096, Israel
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Related Publications (3)
Buti S, Kim SE, Maffezzoli M, Allaf ME, Giudice GC, Banna GL, Taguchi S, Haas NB, Carducci MA. A prospective external validation of the GRade, Age, Nodes and Tumor score in the ECOG-ACRIN EA8143 PROSPER trial. Oncologist. 2026 Mar 9;31(4):oyag041. doi: 10.1093/oncolo/oyag041.
PMID: 41693026DERIVEDAllaf ME, Kim SE, Master V, McDermott DF, Harshman LC, Cole SM, Drake CG, Signoretti S, Akgul M, Baniak N, Li-Ning E, Palmer MB, Emamekhoo H, Adra N, Kaimakliotis H, Ged Y, Pierorazio PM, Abel EJ, Bilen MA, Ogan K, Moon HH, Ramaswamy KA, Singer EA, Mayer TM, Lohrey J, Margulis V, Gills J, Delacroix SE, Waples MJ, James AC, Wang P, Choueiri T, Michaelson MD, Kapoor A, Heng DY, Shuch B, Leibovich BC, Lara PN, Manola J, Maskens D, Battle D, Uzzo R, Bratslavsky G, Haas NB, Carducci MA. Perioperative nivolumab versus observation in patients with renal cell carcinoma undergoing nephrectomy (PROSPER ECOG-ACRIN EA8143): an open-label, randomised, phase 3 study. Lancet Oncol. 2024 Aug;25(8):1038-1052. doi: 10.1016/S1470-2045(24)00211-0. Epub 2024 Jun 25.
PMID: 38942046DERIVEDMarconi L, Sun M, Beisland C, Klatte T, Ljungberg B, Stewart GD, Dabestani S, Choueiri TK, Bex A. Prevalence, Disease-free, and Overall Survival of Contemporary Patients With Renal Cell Carcinoma Eligible for Adjuvant Checkpoint Inhibitor Trials. Clin Genitourin Cancer. 2021 Apr;19(2):e92-e99. doi: 10.1016/j.clgc.2020.12.005. Epub 2021 Jan 7.
PMID: 33526329DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- ECOG-ACRIN Statistical Office
Study Officials
- PRINCIPAL INVESTIGATOR
Lauren Harshman
ECOG-ACRIN Cancer Research Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2017
First Posted
February 16, 2017
Study Start
April 28, 2017
Primary Completion
May 24, 2023
Study Completion (Estimated)
June 9, 2031
Last Updated
May 4, 2026
Results First Posted
April 25, 2024
Record last verified: 2026-01