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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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A Study Comparing Nivolumab, Nivolumab in Combination With Ipilimumab and Placebo in Participants With Localized Kidney Cancer Who Underwent Surgery to Remove Part of a Kidney (CheckMate 914)

  • Clinicaltrials.gov identifier

    NCT03138512

  • Recruitment Status

    Recruiting

  • First Posted

    May 3, 2017

  • Last update posted

    October 18, 2021

Study Description

Brief summary:

The purpose of this study is to determine whether nivolmab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in participants who have experienced partial or entire removal of a kidney.

  • Condition or Disease:Renal Cell Carcinoma
  • Intervention/Treatment: Biological: nivolumab
    Biological: ipilimumab
    Drug: nivolumab placebo
    Drug: ipilimumab placebo
  • Phase: Phase 3

Detailed Description

The study has two primary endpoints. The first primary completion date is anticipated to be reached Aug 2022 (DFS in Part A). The second primary completion date is anticipated to be reached July 2024 (DFS in Part B).

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 1600 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab vs Placebo in Participants With Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse
  • Actual Study Start Date: July 2017
  • Estimated Primary Completion Date: July 2024
  • Estimated Study Completion Date: August 2032

Arms and interventions

Arm Intervention/treatment
Experimental: Part A, Arm A: nivolumab + ipilimumab
Biological: nivolumab
Specified dose on specified days

Biological: ipilimumab
Specified dose on specified days
Experimental: Part B, Arm A: nivolumab + ipilimumab
Biological: nivolumab
Specified dose on specified days

Biological: ipilimumab
Specified dose on specified days

Drug: ipilimumab placebo
Specified dose on specified days
Experimental: Part B, Arm C: nivolumab + ipilimumab placebo
Biological: nivolumab
Specified dose on specified days

Drug: nivolumab placebo
Specified dose on specified days

Drug: ipilimumab placebo
Specified dose on specified days
Placebo Comparator: Part A, Arm B: nivolumab placebo + ipilimumab placebo
Drug: nivolumab placebo
Specified dose on specified days

Drug: ipilimumab placebo
Specified dose on specified days
Placebo Comparator: Part B, Arm B: nivolumab placebo + ipilimumab placebo
Drug: nivolumab placebo
Specified dose on specified days

Drug: ipilimumab placebo
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Disease-free survival (DFS) as assessed by BICR (Part A and Part B) [ Time Frame: Up to 10 years ]
  • Secondary Outcome Measures: 1. Overall Survival (OS) (Part A and Part B) [ Time Frame: Up to 10 years ]
  • 2. Incidence of Adverse Events (AEs) (Part A and Part B) [ Time Frame: Up to 100 days after the last dose of study treatment ]
  • 3. Disease-Free Survival (DFS) as assessed by BICR (Part B: arm A vs. arm C) [ Time Frame: Up to 10 years ]

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Kidney tumor has been completely resected with negative surgical margins obtained. The randomization must occur greater than 4 weeks and less than (or equal to) 12 weeks from the date of nephrectomy - Pathologic TNM staging meeting one of the following: pT2a, G3 or G4, N0 M0; pT2b, G any, N0 M0; pT3, (a, b, c), G any, N0 M0; pT4, G any, N0 M0; pT any, G any, N1 M0 - Post-nephrectomy tumor shows RCC with a predominantly clear cell histology, including participants with sarcomatoid features - Participants must have no clinical or radiological evidence of macroscopic residual disease or distant metastases after nephrectomy - Eastern Cooperative Oncology Group (ECOG) Performance Status (0 - 1) - Women must agree to follow methods of contraception, if applicable Exclusion Criteria: - Participants with an active known or suspected autoimmune disease - Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) - Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell con-stimulation or checkpoint pathways - Any severe or serious, acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation - History of allergy or hypersensitivity to study drug components - Participants with a condition requiring systemic treatment with corticosteroids - Participants who have received a live/attenuated vaccine within 30 days of first treatment Other protocol defined inclusion/exclusion criteria apply

Contacts and Locations

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

Austria
Local Institution
Wien

Austria
Krankenhaus der Elisabethinen Linz GmbH
Linz

Belgium
Local Institution
Bruxelles

Belgium
Local Institution
Gent

Belgium
Local Institution
Hasselt

Belgium
Local Institution
Liege

Spain
Hospital Ramon Y Cajal
Madrid

Spain
Local Institution
Madrid

Spain
Local Institution
Barcelona

Spain
Local Institution
Barcelona

Spain
Hospital San Pedro De Alcantara
Caceres

Spain
Local Institution
Cordoba

Spain
H. Lucus Augusti
Lugo

Spain
Hospital Parc Tauli
Sabadell

Spain
Hospital Universitario Virgen Del Rocio
Sevilla

United States, Alabama
Alabama Oncology
Birmingham

United States, Arkansas
Highland Oncology Group
Springdale

United States, California
Cedars Sinai Medical Center
Los Angeles

United States, California
University Of California Los Angeles
Los Angeles

United States, California
California Pacific Medical Center Research Institute
San Francisco

United States, Colorado
University Of Colorado
Aurora

United States, Connecticut
Local Institution
New Haven

United States, Georgia
University Cancer Blood Ctr
Athens

United States, Georgia
Local Institution
Atlanta

United States, Illinois
Northwestern University
Chicago

United States, Illinois
Local Institution
Chicago

United States, Illinois
Local Institution
Chicago

United States, Indiana
Local Institution
Evansville

United States, Massachusetts
Local Institution
Boston

United States, Missouri
Washington University
Saint Louis

United States, New Jersey
Meridan Health System-Jersey Shore Medical Center
Howell

United States, New York
Local Institution
Albany

United States, New York
Roswell Park Cancer Institute
Buffalo

United States, New York
Memorial Sloan Kettering Nassau
New York

United States, New York
Mount Sinai Hospital
New York

United States, Ohio
Ohio State University
Columbus

United States, Oregon
Providence Newburg Medical Center
Portland

United States, Oregon
Local Institution
Portland

United States, Pennsylvania
Lehigh Valley Hospital
Allentown

United States, South Carolina
Bon Secours-St Francis Hosp
Greenville

United States, Tennessee
Erlanger Oncology & Hematology - Univ. of TN
Chattanooga

United States, Tennessee
Vanderbilt University Medical Center
Nashville

United States, Texas
Local Institution
Houston

United States, Utah
Local Institution
Salt Lake City

United States, Virginia
Inova Schar Cancer Institute
Fairfax

United States, Washington
Local Institution
Seattle

United States, Washington
Local Institution
Seattle

Argentina, Buenos Aires
Hospital Britanico
Capital Federal

Argentina, Buenos Aires
Local Institution
Capital Federal

Argentina, Buenos Aires
Hospital Privado De Comunidad
Mar Del Plata

Argentina, Buenos Aires
Local Institution
Mar del Plata

Argentina, Cordoba
Instituto Medico Rio Cuarto S.A.
Rio Cuarto

Argentina, RIO Negro
Local Institution
Bariloche

Argentina
Local Institution
Buenos Aires

Argentina
Local Institution
Buenos Aires

Argentina
Hospital Italiano De Buenos Aires
Caba

Argentina
Local Institution
Caba

Argentina
Instituto Oncologico De Cordoba
Cordoba

Argentina
Clinica Universitaria Reina Fabiola
Cordoba

Argentina
Centro Polivalente de Asistencia e Investigacion Clinica CER San Juan
San Juan

Argentina
Centro Medico San Roque
Tucuman

Australia, New South Wales
Local Institution
Macquarie Park

Australia, New South Wales
Westmead Hospital
Northmead

Australia, New South Wales
Prince Of Wales Hospital
Randwick

Australia, New South Wales
Royal North Shore Hospital
Sydney

Australia, Queensland
Integrated Clinical Oncology Network Pty Ltd (ICON)
Chermside

Australia, Queensland
Local Institution
Southport

Australia, South Australia
Lyell McEwin Hospital
Elizabeth Vale

Australia, Victoria
Austin Health - ONJCRI (VIC)
Heidelberg

Australia, Victoria
Cabrini Hospital
Malvern

Australia, Western Australia
St John of God Murdoch Hospital
Perth

Brazil, Distrito Federal
Hospital Sirio Libanes
Brasilia

Brazil, Minas Gerais
PERSONAL Oncologia de Precisao e Personalizada
Belo Horizonte

Brazil, RIO Grande DO SUL
Associacao Hospital de Caridade Ijui
Ijui

Brazil, RIO Grande DO SUL
Hospital Sao Lucas Da Pucrs
Porto Alegre

Brazil, Sao Paulo
Fundacao Pio Xii Hosp Cancer De Barretos
Barretos

Brazil, SAO Paulo
Instituto do Cancer do Estado de Sao Paulo ICESP
Cerqueira Cesar

Brazil
COI Clinicas Oncologicas Integradas SA
Rio de Janeiro

Brazil
Hospital Israelita Albert Einstein
Sao Paulo

Canada, British Columbia
Local Institution
Vancouver

Canada, New Brunswick
Local Institution
Saint John

Canada, Ontario
Local Institution
Toronto

Canada, Quebec
Local Institution
Rimouski

Canada
Local Institution
Montreal

Canada
Local Institution
Oshawa

Chile, Coquimbo
Local Institution
La Serena

Chile, Metropolitana
Local Institution
Santiago

Chile, Metropolitana
Local Institution
Santiago

Chile, Metropolitana
Local Institution
Santiago

Chile, Valparaiso
Local Institution
Vina del Mar

China, Beijing
Local Institution
Beijing

China, Beijing
Local Institution
Beijing

China, Beijing
Local Institution
Beijing

China, Fujian
Local Institution
Fuzhou

China, Guangdong
Local Institution
Guangzhou

China, Hebei
Local Institution
Wuhan

China, Hubei
Local Institution
Wuhan

China, Jiangsu
Local Institution
Nanjing

China, Jiangsu
Local Institution
Nanjing

China, Jiangxi
Local Institution
Nanchang

China, Jilin
Local Institution
Changchun

China, Shandong
Local Institution
Yantai

China, Shanghai
Local Institution
Shanghai

China, Shanghai
Local Institution
Shanghai

China, Shanghai
Local Institution
Shanghai

China, Shanghai
Local Institution
Shanghai

China, Sichuan
Local Institution
Chengdu

China, Sichuan
Local Institution
Chengdu

China, Tianjin
Local Institution
Tianjin

China, Zhejiang
Local Institution
Hangzhou

China, Zhejiang
Local Institution
Hangzhou

China
Local Institution
Guangzhou

China
Local Institution
Shanghai

China
Local Institution
Shanghai

China
Local Institution
Xi'an

Colombia
Instituto Nacional de Cancerología-Clinical Oncology
Bogota

Colombia
Fundacion Cardiovascular De Colombia
Floridablanca

Colombia
Instituto de Cancerologia SA
Medellin

Colombia
Oncologos Del Occidente Sa
Pereira

Colombia
Sociedad de Hemato-Oncologia del Cesar
Valledupar

Czechia
Klinika onkologie a radioterapie
Hradec Kralove

Czechia
Onkologicka klinika
Olomouc

France
Local Institution
Besançon Cedex

France
Local Institution
Bordeaux

France
Local Institution
La Roche sur Yon

France
Local Institution
Lyon Cedex 08

France
Local Institution
Marseille Cedex 9

France
Local Institution
Paris

France
Local Institution
Rennes Cedex

France
Local Institution
Strasbourg

France
Local Institution
Toulouse Cedex 9

France
Local Institution
Tours Cedex

France
Local Institution
Vandoeuvre Les Nancy

France
Local Institution
Villejuif

Germany
Universitaetsklinikum Aachen
Aachen

Germany
Universitaetsklinikum Essen
Essen

Germany
Asklepios Klinik Altona
Hamburg

Germany
Vinzenzkrankenhaus Hannover
Hannover

Germany
Medizinische Hochschule Hannover
Hannover

Germany
Universitaetsklinikum Jena
Jena

Germany
Klinikum Grosshadern
Munich

Germany
Klinikum Nuernberg Nord, Urologische Klinik
Nuernberg

Germany
Universitaetsklinikum Rostock
Rostock

Germany
Universitaetsklinikum Tuebingen
Tuebingen

Germany
Univ. Klinikum Wuerzburg
Wuerzburg

Italy
Local Institution
Arezzo

Italy
A.O. Istituti Ospitalieri Di Cremona
Cremona

Italy
Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli
Napoli

Italy
Azienda Ospedaliera Di Parma
Parma

Italy
Fondazione Policlinico Universitario A. Gemelli
Roma

Italy
Policlinico G. Rossi
Verona

Japan, Aichi
Local Institution
Toyoake Shi

Japan, Aomori
Local Institution
Hirosaki-shi

Japan, Chiba
Local Institution
Chiba-shi

Japan, Fukuoka
Local Institution
Fukuoka-shi

Japan, Hiroshima
Local Institution
Hiroshima-Shi

Japan, Hokkaido
Local Institution
Sapporo-shi

Japan, Hyogo
Local Institution
Kobe-shi

Japan, Ibaraki
Local Institution
Tsukuba-shi

Japan, Iwate
Local Institution
Shiwa-gun

Japan, Kanagawa
Local Institution
Yokohama-shi

Japan, Kumamoto
Local Institution
Kumamoto-shi

Japan, Kyoto
Local Institution
Kyoto-shi

Japan, Nagasaki
Local Institution
Nagasaki-shi

Japan, Niigata
Local Institution
Niigata-shi

Japan, Osaka
Local Institution
Osaka-sayama-shi

Japan, Osaka
Local Institution
Suita-shi

Japan, Tokushima
Local Institution
Tokushima-shi

Japan, Tokyo
Local Institution
Arakawa-ku

Japan, Tokyo
Local Institution
Bunkyo-ku

Japan, Tokyo
Local Institution
Bunkyo-ku

Japan, Tokyo
Local Institution
Shinjuku-Ku

Japan, Wakayama
Local Institution
Wakayama-shi

Japan, Yamagata
Local Institution
Yamagata-shi

Japan, Yamaguchi
Local Institution
Ube-shi

Mexico, Baja California
Local Institution
Tijuana

Mexico, BAJA California
Local Institution
Tijuana

Mexico, Chiapas
Local Institution
Tuxtla Gutierrez

Mexico, Coahuila
Local Institution
Torreon

Mexico, Distrito Federal
Local Institution
Benito Juarez

Mexico, Distrito Federal
Local Institution
Tlalpan

Mexico, Jalisco
Local Institution
Zapopan

Mexico, Nuevo LEON
Local Institution
Monterrey

Mexico, Nuevo LEON
Local Institution
Monterrey

Mexico, Sinaloa
Local Institution
Mazatlan

Mexico, Yucatan
Medical Care and Research SA de CV
Merida

Mexico
Local Institution
Chihuahua

Mexico
Local Institution
San Luis Potosi

Mexico
Local Institution
San Luis Potosi

Netherlands
Local Institution
Amsterdam

Netherlands
Local Institution
Rotterdam

Netherlands
Local Institution
Zwolle

Poland
Local Institution
Biala Podlaska

Poland
Ambulatorium Chemioterapii
Bydgoszcz

Poland
Local Institution
Lublin

Poland
Local Institution
Warsaw

Poland
Oddzial Onkologii Klinicznej
Wroclaw

Romania
Local Institution
Bucharest

Romania
Local Institution
Bucuresti

Romania
Local Institution
Cluj-Napoca

Romania
Local Institution
Cluj

Romania
Local Institution
Craiova

Romania
Local Institution
Iași

Russian Federation
Local Institution
Moscow

Russian Federation
Local Institution
Moscow

Russian Federation
Local Institution
Moscow

Russian Federation
Local Institution
Moscow

Russian Federation
Local Institution
Nizhniy Novgorod

Russian Federation
Local Institution
Novosibirsk

Russian Federation
Local Institution
Saint-Petersburg

Russian Federation
Local Institution
St Petersburg

Singapore
Local Institution
Singapore

Singapore
Local Institution
Singapore

Switzerland
Kantonsspital Graubuenden
Chur

Switzerland
Kantonsspital St.Gallen
Sankt Gallen

Switzerland
Universitaetsspital Zuerich
Zuerich

Turkey
Local Institution
Istanbul

Turkey
Local Institution
Istanbul

Turkey
Local Institution
Mamak/Ankara

United Kingdom, Dumfries & Galloway
Local Institution
Glasgow

United Kingdom, Glamorgan
Local Institution
Swansea

United Kingdom, Greater London
Local Institution
London

United Kingdom, Hampshire
Local Institution
Southampton

United Kingdom
Local Institution
Manchester

United Kingdom
Local Institution
Preston

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT03138512 History of Changes
  • Other Study ID Numbers: CA209-914, 2016-004502-34
  • First Posted: May 3, 2017 Key Record Dates
  • Last Update Posted: October 18, 2021
  • Last Verified: October 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bristol-Myers Squibb: High Risk of Relapse/Recurrence
    Clear cell
    Nephrectomy
    Kidney Cancer
    Renal Cell Carcinoma
    adjuvant
    resected
    localized
  • Additional relevant MeSH terms: Carcinoma, Renal Cell Carcinoma