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

NCT ID: NCT03138512

Last Updated: 2024-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1641 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-07
• Study Completion Date: 2024-02-01

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.

Detailed Description

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

Conditions

Carcinoma, Renal Cell

Keywords

localized; resected; adjuvant; Renal Cell Carcinoma; Kidney Cancer; Nephrectomy; Clear cell; High Risk of Relapse/Recurrence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Part A, Arm A: nivolumab + ipilimumab

Group Type: EXPERIMENTAL

nivolumab

Intervention Type: BIOLOGICAL

Specified dose on specified days

ipilimumab

Intervention Type: BIOLOGICAL

Specified dose on specified days

Part A, Arm B: nivolumab placebo + ipilimumab placebo

Group Type: PLACEBO_COMPARATOR

nivolumab placebo

Intervention Type: DRUG

Specified dose on specified days

ipilimumab placebo

Intervention Type: DRUG

Specified dose on specified days

Part B, Arm A: nivolumab + ipilimumab

Group Type: EXPERIMENTAL

nivolumab

Intervention Type: BIOLOGICAL

Specified dose on specified days

ipilimumab

Intervention Type: BIOLOGICAL

Specified dose on specified days

Part B, Arm B: nivolumab placebo + ipilimumab placebo

Group Type: PLACEBO_COMPARATOR

nivolumab placebo

Intervention Type: DRUG

Specified dose on specified days

ipilimumab placebo

Intervention Type: DRUG

Specified dose on specified days

Part B, Arm C: nivolumab + ipilimumab placebo

Group Type: EXPERIMENTAL

nivolumab

Intervention Type: BIOLOGICAL

Specified dose on specified days

ipilimumab placebo

Intervention Type: DRUG

Specified dose on specified days

Interventions

nivolumab

Specified dose on specified days

Intervention Type: BIOLOGICAL

ipilimumab

Specified dose on specified days

Intervention Type: BIOLOGICAL

nivolumab placebo

Specified dose on specified days

Intervention Type: DRUG

ipilimumab placebo

Specified dose on specified days

Intervention Type: DRUG

Other Intervention Names

Opdivo; Yervoy

Eligibility Criteria

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 tumor, node, and metastasis (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 renal cell cancer (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 (PS) 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 co-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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Local Institution - 0019

Birmingham, Alabama, United States

Local Institution - 0056

Springdale, Arkansas, United States

Local Institution - 0186

Los Angeles, California, United States

Local Institution - 0180

Los Angeles, California, United States

Local Institution - 0002

San Francisco, California, United States

Local Institution - 0185

Aurora, Colorado, United States

Local Institution - 0016

Athens, Georgia, United States

Local Institution - 0005

Chicago, Illinois, United States

Local Institution

Chicago, Illinois, United States

Local Institution - 0006

St Louis, Missouri, United States

Local Institution - 0012

Howell Township, New Jersey, United States

Local Institution - 0007

Buffalo, New York, United States

Local Institution - 0181

New York, New York, United States

Local Institution - 0001

New York, New York, United States

Local Institution - 0008

Columbus, Ohio, United States

Local Institution - 0009

Portland, Oregon, United States

Local Institution - 0010

Allentown, Pennsylvania, United States

Local Institution - 0014

Greenville, South Carolina, United States

Local Institution - 0013

Chattanooga, Tennessee, United States

Local Institution - 0183

Nashville, Tennessee, United States

Local Institution - 0057

Fairfax, Virginia, United States

Local Institution - 0178

Capital Federal, Buenos Aires, Argentina

Local Institution - 0126

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0203

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0095

Mar del Plata, Buenos Aires, Argentina

Local Institution - 0208

Mar del Plata, Buenos Aires, Argentina

Local Institution - 0173

Río Cuarto, Córdoba Province, Argentina

Local Institution - 0232

Bariloche, Río Negro Province, Argentina

Local Institution - 0179

Buenos Aires, , Argentina

Local Institution - 0099

CABA, , Argentina

Local Institution - 0096

Córdoba, , Argentina

Local Institution - 0098

Córdoba, , Argentina

Local Institution - 0164

San Juan, , Argentina

Local Institution - 0097

San Miguel de Tucumán, , Argentina

Local Institution - 0215

Macquarie Park, New South Wales, Australia

Local Institution - 0032

Northmead, New South Wales, Australia

Local Institution - 0036

Randwick, New South Wales, Australia

Local Institution - 0035

St Leonards, New South Wales, Australia

Local Institution - 0113

South Brisbane, Queensland, Australia

Local Institution - 0213

Southport, Queensland, Australia

Local Institution - 0034

Elizabeth Vale, South Australia, Australia

Local Institution - 0033

Clayton, Victoria, Australia

Local Institution - 0214

Heidelberg, Victoria, Australia

Local Institution - 0031

Murdoch, Western Australia, Australia

Local Institution - 0068

Linz, , Austria

Local Institution - 0084

Vienna, , Austria

Local Institution - 0058

Ghent, Oost-Vlaanderen, Belgium

Local Institution - 0064

Anderlecht, , Belgium

Local Institution - 0060

Hasselt, , Belgium

Local Institution - 0059

Liège, , Belgium

Local Institution - 0047

Brasília, Federal District, Brazil

Local Institution - 0045

Belo Horizonte, Minas Gerais, Brazil

Local Institution - 0046

Ijuí, Rio Grande do Sul, Brazil

Local Institution - 0048

Porto Alegre, Rio Grande do Sul, Brazil

Local Institution - 0043

Barretos, São Paulo, Brazil

Local Institution - 0044

São Paulo, São Paulo, Brazil

Local Institution - 0160

Rio de Janeiro, , Brazil

Local Institution - 0050

São Paulo, , Brazil

Local Institution - 0041

Vancouver, British Columbia, Canada

Local Institution - 0086

Saint John, New Brunswick, Canada

Local Institution - 0087

Oshawa, Ontario, Canada

Local Institution - 0112

Toronto, Ontario, Canada

Local Institution - 0042

Montreal, Quebec, Canada

Local Institution - 0040

Rimouski, Quebec, Canada

Local Institution - 0223

La Serena, Coquimbo Region, Chile

Local Institution - 0222

Viña del Mar, Región de Valparaíso, Chile

Local Institution - 0246

Santiago, Santiago Metropolitan, Chile

Local Institution

Santiago, Santiago Metropolitan, Chile

Local Institution - 0221

Santiago, Santiago Metropolitan, Chile

Local Institution - 0147

Beijing, Beijing Municipality, China

Local Institution - 0153

Beijing, Beijing Municipality, China

Local Institution - 0159

Beijing, Beijing Municipality, China

Local Institution - 0132

Fuzhou, Fujian, China

Local Institution - 0141

Guangzhou, Guangdong, China

Local Institution - 0194

Wuhan, Hebei, China

Local Institution - 0133

Wuhan, Hubei, China

Local Institution - 0138

Nanjing, Jiangsu, China

Local Institution - 0140

Nanchang, Jiangxi, China

Local Institution - 0145

Changchun, Jilin, China

Local Institution - 0144

Xi'an, Shan3xi, China

Local Institution - 0146

Yantai, Shandong, China

Local Institution - 0137

Shanghai, Shanghai Municipality, China

Local Institution - 0166

Shanghai, Shanghai Municipality, China

Local Institution - 0152

Shanghai, Shanghai Municipality, China

Local Institution - 0148

Shanghai, Shanghai Municipality, China

Local Institution - 0142

Chengdu, Sichuan, China

Local Institution - 0143

Chengdu, Sichuan, China

Local Institution - 0175

Tianjin, Tianjin Municipality, China

Local Institution - 0157

Hangzhou, Zhejiang, China

Local Institution - 0131

Hangzhou, Zhejiang, China

Local Institution - 0134

Guangzhou, , China

Local Institution - 0139

Nanjing, , China

Local Institution - 0176

Shanghai, , China

Local Institution - 0227

Medellín, Antioquia, Colombia

Local Institution - 0228

Valledupar, Cesar Department, Colombia

Local Institution - 0229

Bogotá, , Colombia

Local Institution - 0230

Floridablanca, , Colombia

Local Institution - 0226

Pereira, , Colombia

Local Institution - 0094

Hradec Králové, , Czechia

Local Institution - 0025

Olomouc, , Czechia

Local Institution - 0083

Besançon, , France

Local Institution - 0080

Bordeaux, , France

Local Institution - 0082

La Roche-sur-Yon, , France

Local Institution - 0116

Lyon, , France

Local Institution - 0079

Marseille, , France

Local Institution - 0198

Paris, , France

Local Institution - 0081

Rennes, , France

Local Institution - 0077

Strasbourg, , France

Local Institution - 0115

Toulouse, , France

Local Institution - 0150

Tours, , France

Local Institution - 0078

Vandœuvre-lès-Nancy, , France

Local Institution - 0076

Villejuif, , France

Local Institution - 0217

Tübingen, Baden-Wurttemberg, Germany

Local Institution - 0053

Aachen, , Germany

Local Institution - 0103

Essen, , Germany

Local Institution - 0052

Hamburg, , Germany

Local Institution - 0231

Hanover, , Germany

Local Institution - 0061

Hanover, , Germany

Local Institution - 0062

Jena, , Germany

Local Institution - 0102

Munich, , Germany

Local Institution - 0054

Nuremberg, , Germany

Local Institution - 0055

Rostock, , Germany

Local Institution - 0101

Würzburg, , Germany

Local Institution - 0105

Arezzo, , Italy

Local Institution - 0172

Cremona, , Italy

Local Institution - 0106

Napoli, , Italy

Local Institution - 0107

Parma, , Italy

Local Institution - 0109

Roma, , Italy

Local Institution - 0108

Verona, , Italy

Local Institution - 0129

Toyoake Shi, Aichi-ken, Japan

Local Institution - 0193

Hirosaki-shi, Aomori, Japan

Local Institution - 0158

Chiba, Chiba, Japan

Local Institution - 0121

Fukuoka, Fukuoka, Japan

Local Institution - 0156

Sapporo, Hokkaido, Japan

Local Institution - 0167

Kobe, Hyōgo, Japan

Local Institution - 0191

Tsukuba, Ibaraki, Japan

Local Institution - 0168

Shiwa-gun, Iwate, Japan

Local Institution - 0128

Yokohama, Kanagawa, Japan

Local Institution - 0216

Kumamoto, Kumamoto, Japan

Local Institution - 0130

Kamigyō-ku, Kyoto, Japan

Local Institution - 0123

Nagasaki, Nagasaki, Japan

Local Institution - 0120

Niigata, Niigata, Japan

Local Institution - 0125

Osakasayama-shi, Osaka, Japan

Local Institution - 0122

Suita-shi, Osaka, Japan

Local Institution - 0162

Tokushima, Tokushima, Japan

Local Institution - 0188

Adachi-ku, Tokyo, Japan

Local Institution - 0189

Bunkyo-ku, Tokyo, Japan

Local Institution - 0119

Bunkyo-ku, Tokyo, Japan

Local Institution - 0149

Shinjuku-ku, Tokyo, Japan

Local Institution - 0163

Ube-shi, Yamaguchi, Japan

Local Institution - 0165

Hiroshima, , Japan

Local Institution - 0192

Wakayama, , Japan

Local Institution - 0127

Yamagata, , Japan

Local Institution - 0197

Tuxtla Gutiérrez, Chiapas, Mexico

Local Institution - 0195

Torreón, Coahuila, Mexico

Local Institution - 0242

Tijuana, Estado de Baja California, Mexico

Local Institution - 0110

Zapopan, Jalisco, Mexico

Local Institution - 0151

Mexico City, Mexico City, Mexico

Local Institution - 0111

Tlalpan, Mexico City, Mexico

Local Institution - 0104

Mazatlán, Sinaloa, Mexico

Local Institution - 0196

Mérida, Yucatán, Mexico

Local Institution - 0089

Chihuahua City, , Mexico

Local Institution - 0088

Monterrey, NL, , Mexico

Local Institution - 0169

San Luis Potosí City, , Mexico

Local Institution - 0066

Amsterdam, , Netherlands

Local Institution - 0067

Rotterdam, , Netherlands

Local Institution - 0092

Zwolle, , Netherlands

Local Institution - 0155

Bydgoszcz, , Poland

Local Institution - 0038

Wroclaw, , Poland

Local Institution - 0243

Bucharest, , Romania

Local Institution - 0200

Cluj-Napoca, , Romania

Local Institution - 0247

Cluj-Napoca, , Romania

Local Institution - 0199

Craiova, , Romania

Local Institution - 0202

Iași, , Romania

Local Institution - 0065

Moscow, , Russia

Local Institution - 0170

Novosibirsk, , Russia

Local Institution - 0171

Saint Petersburg, , Russia

Local Institution - 0021

Saint Petersburg, , Russia

Local Institution - 0018

Singapore, Central Singapore, Singapore

Local Institution - 0017

Singapore, , Singapore

Local Institution - 0204

Barcelona, , Spain

Local Institution - 0206

Barcelona, , Spain

Local Institution - 0124

Cáceres, , Spain

Local Institution - 0207

Córdoba, , Spain

Local Institution - 0118

Lugo, , Spain

Local Institution - 0114

Madrid, , Spain

Local Institution - 0205

Madrid, , Spain

Local Institution - 0117

Sabadell, , Spain

Local Institution - 0161

Seville, , Spain

Local Institution - 0218

Chur, , Switzerland

Local Institution - 0219

Sankt Gallen, , Switzerland

Local Institution - 0225

Zurich, , Switzerland

Local Institution - 0209

Ankara, , Turkey (Türkiye)

Local Institution - 0210

Istanbul, , Turkey (Türkiye)

Local Institution

Istanbul, , Turkey (Türkiye)

Local Institution - 0075

Southampton, Hampshire, United Kingdom

Local Institution - 0063

Manchester, , United Kingdom

Local Institution - 0071

Northwood, , United Kingdom

Local Institution - 0073

Preston, , United Kingdom

Local Institution - 0072

Swansea, , United Kingdom

Countries

United States; Argentina; Australia; Austria; Belgium; Brazil; Canada; Chile; China; Colombia; Czechia; France; Germany; Italy; Japan; Mexico; Netherlands; Poland; Romania; Russia; Singapore; Spain; Switzerland; Turkey (Türkiye); United Kingdom

References

Motzer RJ, Bex A, Russo P, Tomita Y, Cutuli HJ, Rojas C, Gross-Goupil M, Schinzari G, Melichar B, Barthelemy P, Ruiz Garcia A, Sosman J, Grimm MO, Goh JC, Suarez C, Kollmannsberger CK, Nair SG, Shuch BM, Huang J, Simsek B, Spiridigliozzi J, Lee CW, van Kooten Losio M, Grunwald V. Adjuvant Nivolumab for Localized Renal Cell Carcinoma at High Risk of Recurrence After Nephrectomy: Part B of the Randomized, Placebo-Controlled, Phase III CheckMate 914 Trial. J Clin Oncol. 2025 Jan 10;43(2):189-200. doi: 10.1200/JCO.24.00773. Epub 2024 Sep 20.

Reference Type: DERIVED

PMID: 39303200 (View on PubMed)

Motzer RJ, Russo P, Grunwald V, Tomita Y, Zurawski B, Parikh O, Buti S, Barthelemy P, Goh JC, Ye D, Lingua A, Lattouf JB, Albiges L, George S, Shuch B, Sosman J, Staehler M, Vazquez Estevez S, Simsek B, Spiridigliozzi J, Chudnovsky A, Bex A. Adjuvant nivolumab plus ipilimumab versus placebo for localised renal cell carcinoma after nephrectomy (CheckMate 914): a double-blind, randomised, phase 3 trial. Lancet. 2023 Mar 11;401(10379):821-832. doi: 10.1016/S0140-6736(22)02574-0. Epub 2023 Feb 9.

Reference Type: DERIVED

PMID: 36774933 (View on PubMed)

Marconi 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.

Reference Type: DERIVED

PMID: 33526329 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

http://www.BMSStudyConnect.com

BMS Clinical Trial Patient Recruiting

Other Identifiers

2016-004502-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA209-914

Identifier Type: -

Identifier Source: org_study_id