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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)

Primary Purpose

Carcinoma, Renal Cell

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

nivolumab

ipilimumab

nivolumab placebo

ipilimumab placebo

About this trial

This is an interventional treatment trial for Carcinoma, Renal Cell focused on measuring localized, resected, adjuvant, Renal Cell Carcinoma, Kidney Cancer, Nephrectomy, Clear cell, High Risk of Relapse/Recurrence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Other protocol-defined inclusion/exclusion criteria apply

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Part A, Arm A: nivolumab + ipilimumab

Part A, Arm B: nivolumab placebo + ipilimumab placebo

Part B, Arm A: nivolumab + ipilimumab

Part B, Arm B: nivolumab placebo + ipilimumab placebo

Part B, Arm C: nivolumab + ipilimumab placebo

Arm Description

Outcomes

Primary Outcome Measures

Disease-free survival (DFS) as assessed by BICR (Part A and Part B)

Secondary Outcome Measures

Overall Survival (OS) (Part A and Part B)

Incidence of Adverse Events (AEs) (Part A and Part B)

Disease-Free Survival (DFS) as assessed by BICR (Part B: arm A vs. arm C)

Full Information

NCT ID

NCT03138512

First Posted

May 1, 2017

Last Updated

October 11, 2023

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT03138512

Brief Title

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

Acronym

CheckMate 914

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 7, 2017 (Actual)

Primary Completion Date

September 12, 2023 (Actual)

Study Completion Date

August 23, 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Renal Cell

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1653 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part A, Arm A: nivolumab + ipilimumab

Arm Type

Experimental

Arm Title

Part A, Arm B: nivolumab placebo + ipilimumab placebo

Arm Type

Placebo Comparator

Arm Title

Part B, Arm A: nivolumab + ipilimumab

Arm Type

Experimental

Arm Title

Part B, Arm B: nivolumab placebo + ipilimumab placebo

Arm Type

Placebo Comparator

Arm Title

Part B, Arm C: nivolumab + ipilimumab placebo

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

nivolumab

Other Intervention Name(s)

Opdivo

Intervention Description

Specified dose on specified days

Intervention Type

Biological

Intervention Name(s)

ipilimumab

Other Intervention Name(s)

Yervoy

Intervention Description

Specified dose on specified days

Intervention Type

Drug

Intervention Name(s)

nivolumab placebo

Intervention Description

Specified dose on specified days

Intervention Type

Drug

Intervention Name(s)

ipilimumab placebo

Intervention Description

Specified dose on specified days

Primary Outcome Measure Information:

Title

Disease-free survival (DFS) as assessed by BICR (Part A and Part B)

Time Frame

Up to 10 years

Secondary Outcome Measure Information:

Title

Overall Survival (OS) (Part A and Part B)

Time Frame

Up to 10 years

Title

Incidence of Adverse Events (AEs) (Part A and Part B)

Time Frame

Up to 100 days after the last dose of study treatment

Title

Disease-Free Survival (DFS) as assessed by BICR (Part B: arm A vs. arm C)

Time Frame

Up to 10 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 Other protocol-defined inclusion/exclusion criteria apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Local Institution - 0019

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

Local Institution - 0056

City

Springdale

State/Province

Arkansas

ZIP/Postal Code

72762

Country

United States

Facility Name

Local Institution - 0186

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

Local Institution - 0180

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Local Institution - 0002

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

Local Institution - 0185

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Local Institution - 0016

City

Athens

State/Province

Georgia

ZIP/Postal Code

30607

Country

United States

Facility Name

Local Institution - 0005

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Local Institution

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Local Institution - 0006

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Local Institution - 0012

City

Howell

State/Province

New Jersey

ZIP/Postal Code

07731

Country

United States

Facility Name

Local Institution - 0007

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263

Country

United States

Facility Name

Local Institution - 0181

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Local Institution - 0001

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Local Institution - 0008

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Local Institution - 0009

City

Portland

State/Province

Oregon

ZIP/Postal Code

97213

Country

United States

Facility Name

Local Institution - 0010

City

Allentown

State/Province

Pennsylvania

ZIP/Postal Code

18103

Country

United States

Facility Name

Local Institution - 0014

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29607

Country

United States

Facility Name

Local Institution - 0013

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37404

Country

United States

Facility Name

Local Institution - 0183

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

Local Institution - 0057

City

Fairfax

State/Province

Virginia

ZIP/Postal Code

22031

Country

United States

Facility Name

Local Institution - 0178

City

Capital Federal

State/Province

Buenos Aires

ZIP/Postal Code

1280

Country

Argentina

Facility Name

Local Institution - 0126

City

Ciudad Autonoma de Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

1425

Country

Argentina

Facility Name

Local Institution - 0203

City

Ciudad Autónoma De Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

1426

Country

Argentina

Facility Name

Local Institution - 0095

City

Mar Del Plata

State/Province

Buenos Aires

ZIP/Postal Code

7600

Country

Argentina

Facility Name

Local Institution - 0208

City

Mar Del Plata

State/Province

Buenos Aires

ZIP/Postal Code

B7600FZO

Country

Argentina

Facility Name

Local Institution - 0173

City

Rio Cuarto

State/Province

Cordoba

ZIP/Postal Code

5800

Country

Argentina

Facility Name

Local Institution - 0232

City

Bariloche

State/Province

RIO Negro

ZIP/Postal Code

Country

Argentina

Facility Name

Local Institution - 0179

City

Buenos Aires

ZIP/Postal Code

C1419AHN

Country

Argentina

Facility Name

Local Institution - 0099

City

Caba

ZIP/Postal Code

1199

Country

Argentina

Facility Name

Local Institution - 0096

City

Cordoba

ZIP/Postal Code

5000

Country

Argentina

Facility Name

Local Institution - 0098

City

Cordoba

ZIP/Postal Code

X5004FHP

Country

Argentina

Facility Name

Local Institution - 0164

City

San Juan

ZIP/Postal Code

5402

Country

Argentina

Facility Name

Local Institution - 0097

City

Tucuman

ZIP/Postal Code

4000

Country

Argentina

Facility Name

Local Institution - 0215

City

Macquarie Park

State/Province

New South Wales

ZIP/Postal Code

2109

Country

Australia

Facility Name

Local Institution - 0032

City

Northmead

State/Province

New South Wales

ZIP/Postal Code

2152

Country

Australia

Facility Name

Local Institution - 0036

City

Randwick

State/Province

New South Wales

ZIP/Postal Code

2031

Country

Australia

Facility Name

Local Institution - 0035

City

St Leonards

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Facility Name

Local Institution - 0113

City

South Brisbane

State/Province

Queensland

ZIP/Postal Code

4101

Country

Australia

Facility Name

Local Institution - 0213

City

Southport

State/Province

Queensland

ZIP/Postal Code

4215

Country

Australia

Facility Name

Local Institution - 0034

City

Elizabeth Vale

State/Province

South Australia

ZIP/Postal Code

5112

Country

Australia

Facility Name

Local Institution - 0033

City

Clayton

State/Province

Victoria

ZIP/Postal Code

Country

Australia

Facility Name

Local Institution - 0214

City

Heidelberg

State/Province

Victoria

ZIP/Postal Code

3084

Country

Australia

Facility Name

Local Institution - 0031

City

Murdoch

State/Province

Western Australia

ZIP/Postal Code

6150

Country

Australia

Facility Name

Local Institution - 0068

City

Linz

ZIP/Postal Code

4020

Country

Austria

Facility Name

Local Institution - 0084

City

Wien

ZIP/Postal Code

1160

Country

Austria

Facility Name

Local Institution - 0058

City

Gent

State/Province

Oost-Vlaanderen

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Local Institution - 0064

City

Anderlecht

ZIP/Postal Code

1070

Country

Belgium

Facility Name

Local Institution - 0060

City

Hasselt

ZIP/Postal Code

3500

Country

Belgium

Facility Name

Local Institution - 0059

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Local Institution - 0047

City

Brasilia

State/Province

Distrito Federal

ZIP/Postal Code

70200-730

Country

Brazil

Facility Name

Local Institution - 0045

City

Belo Horizonte

State/Province

Minas Gerais

ZIP/Postal Code

30130-090

Country

Brazil

Facility Name

Local Institution - 0046

City

Ijui

State/Province

RIO Grande DO SUL

ZIP/Postal Code

98700-000

Country

Brazil

Facility Name

Local Institution - 0048

City

Porto Alegre

State/Province

RIO Grande DO SUL

ZIP/Postal Code

90610-000

Country

Brazil

Facility Name

Local Institution - 0043

City

Barretos

State/Province

Sao Paulo

ZIP/Postal Code

14780-070

Country

Brazil

Facility Name

Local Institution - 0044

City

São Paulo

State/Province

SAO Paulo

ZIP/Postal Code

05652-900

Country

Brazil

Facility Name

Local Institution - 0160

City

Rio de Janeiro

ZIP/Postal Code

20775-001

Country

Brazil

Facility Name

Local Institution - 0050

City

Sao Paulo

ZIP/Postal Code

01246000

Country

Brazil

Facility Name

Local Institution - 0041

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E6

Country

Canada

Facility Name

Local Institution - 0086

City

Saint John

State/Province

New Brunswick

ZIP/Postal Code

E2L 3L6

Country

Canada

Facility Name

Local Institution - 0087

City

Oshawa

State/Province

Ontario

ZIP/Postal Code

L1G 2B9

Country

Canada

Facility Name

Local Institution - 0112

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

Local Institution - 0042

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2X 0C1

Country

Canada

Facility Name

Local Institution - 0040

City

Rimouski

State/Province

Quebec

ZIP/Postal Code

G5L 5T1

Country

Canada

Facility Name

Local Institution - 0223

City

La Serena

State/Province

Coquimbo

ZIP/Postal Code

1720430

Country

Chile

Facility Name

Local Institution - 0246

City

Santiago

State/Province

Metropolitana

ZIP/Postal Code

Country

Chile

Facility Name

Local Institution

City

Santiago

State/Province

Metropolitana

ZIP/Postal Code

7500713

Country

Chile

Facility Name

Local Institution - 0221

City

Santiago

State/Province

Metropolitana

ZIP/Postal Code

8420383

Country

Chile

Facility Name

Local Institution - 0222

City

Vina del Mar

State/Province

Valparaiso

ZIP/Postal Code

2520598

Country

Chile

Facility Name

Local Institution - 0147

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100032

Country

China

Facility Name

Local Institution - 0153

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100034

Country

China

Facility Name

Local Institution - 0159

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100853

Country

China

Facility Name

Local Institution - 0132

City

Fuzhou

State/Province

Fujian

ZIP/Postal Code

350001

Country

China

Facility Name

Local Institution - 0141

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510120

Country

China

Facility Name

Local Institution - 0194

City

Wuhan

State/Province

Hebei

ZIP/Postal Code

430030

Country

China

Facility Name

Local Institution - 0133

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430061

Country

China

Facility Name

Local Institution - 0138

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210029

Country

China

Facility Name

Local Institution - 0140

City

Nanchang

State/Province

Jiangxi

ZIP/Postal Code

Country

China

Facility Name

Local Institution - 0145

City

Changchun

State/Province

Jilin

ZIP/Postal Code

130021

Country

China

Facility Name

Local Institution - 0144

City

Xi'an

State/Province

Shan3xi

ZIP/Postal Code

710061

Country

China

Facility Name

Local Institution - 0146

City

Yantai

State/Province

Shandong

ZIP/Postal Code

264000

Country

China

Facility Name

Local Institution - 0137

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200025

Country

China

Facility Name

Local Institution - 0166

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Name

Local Institution - 0152

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200040

Country

China

Facility Name

Local Institution - 0148

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200433

Country

China

Facility Name

Local Institution - 0142

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610041

Country

China

Facility Name

Local Institution - 0143

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610072

Country

China

Facility Name

Local Institution - 0175

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300222

Country

China

Facility Name

Local Institution - 0157

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310009

Country

China

Facility Name

Local Institution - 0131

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310014

Country

China

Facility Name

Local Institution - 0134

City

Guangzhou

ZIP/Postal Code

Country

China

Facility Name

Local Institution - 0139

City

Nanjing

ZIP/Postal Code

210008

Country

China

Facility Name

Local Institution - 0176

City

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Name

Local Institution - 0227

City

Medellin

State/Province

Antioquia

ZIP/Postal Code

050034

Country

Colombia

Facility Name

Local Institution - 0228

City

Valledupar

State/Province

Cesar

ZIP/Postal Code

200001

Country

Colombia

Facility Name

Local Institution - 0229

City

Bogotá

ZIP/Postal Code

111511

Country

Colombia

Facility Name

Local Institution - 0230

City

Floridablanca

ZIP/Postal Code

Country

Colombia

Facility Name

Local Institution - 0226

City

Pereira

ZIP/Postal Code

99999

Country

Colombia

Facility Name

Local Institution - 0094

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Local Institution - 0025

City

Olomouc

ZIP/Postal Code

779 00

Country

Czechia

Facility Name

Local Institution - 0083

City

Besançon Cedex

ZIP/Postal Code

25030

Country

France

Facility Name

Local Institution - 0080

City

Bordeaux

ZIP/Postal Code

33000

Country

France

Facility Name

Local Institution - 0082

City

La Roche-Sur-Yon Cedex 9

ZIP/Postal Code

85925

Country

France

Facility Name

Local Institution - 0116

City

Lyon Cedex 08

ZIP/Postal Code

69373

Country

France

Facility Name

Local Institution - 0079

City

Marseille Cedex 9

ZIP/Postal Code

13273

Country

France

Facility Name

Local Institution - 0198

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

Local Institution - 0081

City

Rennes

ZIP/Postal Code

35042

Country

France

Facility Name

Local Institution - 0077

City

Strasbourg

ZIP/Postal Code

67200

Country

France

Facility Name

Local Institution - 0115

City

Toulouse Cedex 9

ZIP/Postal Code

31059

Country

France

Facility Name

Local Institution - 0150

City

Tours Cedex

ZIP/Postal Code

37044

Country

France

Facility Name

Local Institution - 0078

City

Vandoeuvre Les Nancy

ZIP/Postal Code

54511

Country

France

Facility Name

Local Institution - 0076

City

Villejuif

ZIP/Postal Code

94800

Country

France

Facility Name

Local Institution - 0217

City

Tubingen

State/Province

Baden-Württemberg

ZIP/Postal Code

72076

Country

Germany

Facility Name

Local Institution - 0053

City

Aachen

ZIP/Postal Code

52074

Country

Germany

Facility Name

Local Institution - 0103

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Local Institution - 0052

City

Hamburg

ZIP/Postal Code

22763

Country

Germany

Facility Name

Local Institution - 0231

City

Hannover

ZIP/Postal Code

30559

Country

Germany

Facility Name

Local Institution - 0061

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Local Institution - 0062

City

Jena

ZIP/Postal Code

07747

Country

Germany

Facility Name

Local Institution - 0102

City

Munich

ZIP/Postal Code

81377

Country

Germany

Facility Name

Local Institution - 0054

City

Nuernberg

ZIP/Postal Code

90419

Country

Germany

Facility Name

Local Institution - 0055

City

Rostock

ZIP/Postal Code

18057

Country

Germany

Facility Name

Local Institution - 0101

City

Wuerzburg

ZIP/Postal Code

97080

Country

Germany

Facility Name

Local Institution - 0105

City

Arezzo

ZIP/Postal Code

52100

Country

Italy

Facility Name

Local Institution - 0172

City

Cremona

ZIP/Postal Code

26100

Country

Italy

Facility Name

Local Institution - 0106

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Local Institution - 0107

City

Parma

ZIP/Postal Code

43100

Country

Italy

Facility Name

Local Institution - 0109

City

Roma

ZIP/Postal Code

00168

Country

Italy

Facility Name

Local Institution - 0108

City

Verona

ZIP/Postal Code

37134

Country

Italy

Facility Name

Local Institution - 0129

City

Toyoake Shi

State/Province

Aichi

ZIP/Postal Code

4701192

Country

Japan

Facility Name

Local Institution - 0193

City

Hirosaki-shi

State/Province

Aomori

ZIP/Postal Code

0368563

Country

Japan

Facility Name

Local Institution - 0158

City

Chiba-shi

State/Province

Chiba

ZIP/Postal Code

260-8717

Country

Japan

Facility Name

Local Institution - 0121

City

Fukuoka-shi

State/Province

Fukuoka

ZIP/Postal Code

8128582

Country

Japan

Facility Name

Local Institution - 0156

City

Sapporo-shi

State/Province

Hokkaido

ZIP/Postal Code

0608648

Country

Japan

Facility Name

Local Institution - 0167

City

Kobe-shi

State/Province

Hyogo

ZIP/Postal Code

6500017

Country

Japan

Facility Name

Local Institution - 0191

City

Tsukuba-shi

State/Province

Ibaraki

ZIP/Postal Code

3058576

Country

Japan

Facility Name

Local Institution - 0168

City

Shiwa-gun

State/Province

Iwate

ZIP/Postal Code

0283695

Country

Japan

Facility Name

Local Institution - 0128

City

Yokohama-shi

State/Province

Kanagawa

ZIP/Postal Code

2360004

Country

Japan

Facility Name

Local Institution - 0216

City

Kumamoto-shi

State/Province

Kumamoto

ZIP/Postal Code

860-0811

Country

Japan

Facility Name

Local Institution - 0130

City

Kamigyo-ku

State/Province

Kyoto

ZIP/Postal Code

602-8566

Country

Japan

Facility Name

Local Institution - 0123

City

Nagasaki-shi

State/Province

Nagasaki

ZIP/Postal Code

8528102

Country

Japan

Facility Name

Local Institution - 0120

City

Niigata-shi

State/Province

Niigata

ZIP/Postal Code

9518520

Country

Japan

Facility Name

Local Institution - 0125

City

Osakasayama-shi

State/Province

Osaka

ZIP/Postal Code

5898511

Country

Japan

Facility Name

Local Institution - 0122

City

Suita-shi

State/Province

Osaka

ZIP/Postal Code

565-0871

Country

Japan

Facility Name

Local Institution - 0162

City

Tokushima-shi

State/Province

Tokushima

ZIP/Postal Code

770-8503

Country

Japan

Facility Name

Local Institution - 0188

City

Adachi-ku

State/Province

Tokyo

ZIP/Postal Code

1230872

Country

Japan

Facility Name

Local Institution - 0189

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

113-8510

Country

Japan

Facility Name

Local Institution - 0119

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

113-8603

Country

Japan

Facility Name

Local Institution - 0149

City

Shinjuku-Ku

State/Province

Tokyo

ZIP/Postal Code

1608582

Country

Japan

Facility Name

Local Institution - 0127

City

Yamagata-shi

State/Province

Yamagata

ZIP/Postal Code

9909585

Country

Japan

Facility Name

Local Institution - 0163

City

Ube-shi

State/Province

Yamaguchi

ZIP/Postal Code

7558505

Country

Japan

Facility Name

Local Institution - 0165

City

Hiroshima

ZIP/Postal Code

734-8551

Country

Japan

Facility Name

Local Institution - 0192

City

Wakayama

ZIP/Postal Code

641-8510

Country

Japan

Facility Name

Local Institution - 0242

City

Tijuana

State/Province

BAJA California

ZIP/Postal Code

22010

Country

Mexico

Facility Name

Local Institution - 0197

City

Tuxtla Gutierrez

State/Province

Chiapas

ZIP/Postal Code

29090

Country

Mexico

Facility Name

Local Institution - 0195

City

Torreón

State/Province

Coahuila

ZIP/Postal Code

27010

Country

Mexico

Facility Name

Local Institution - 0151

City

Ciudad de Mexico

State/Province

Distrito Federal

ZIP/Postal Code

03100

Country

Mexico

Facility Name

Local Institution - 0111

City

Tlalpan

State/Province

Distrito Federal

ZIP/Postal Code

14080

Country

Mexico

Facility Name

Local Institution - 0110

City

Zapopan

State/Province

Jalisco

ZIP/Postal Code

45030

Country

Mexico

Facility Name

Local Institution - 0104

City

Mazatlan

State/Province

Sinaloa

ZIP/Postal Code

82110

Country

Mexico

Facility Name

Local Institution - 0196

City

Merida

State/Province

Yucatan

ZIP/Postal Code

97070

Country

Mexico

Facility Name

Local Institution - 0089

City

Chihuahua

ZIP/Postal Code

31000

Country

Mexico

Facility Name

Local Institution - 0088

City

Monterrey, NL

ZIP/Postal Code

64060

Country

Mexico

Facility Name

Local Institution - 0169

City

San Luis Potosi

ZIP/Postal Code

78250

Country

Mexico

Facility Name

Local Institution - 0066

City

Amsterdam

ZIP/Postal Code

1066 CX

Country

Netherlands

Facility Name

Local Institution - 0067

City

Rotterdam

ZIP/Postal Code

3008 AE

Country

Netherlands

Facility Name

Local Institution - 0092

City

Zwolle

ZIP/Postal Code

8025 AB

Country

Netherlands

Facility Name

Local Institution - 0155

City

Bydgoszcz

ZIP/Postal Code

85-796

Country

Poland

Facility Name

Local Institution - 0038

City

Wroclaw

ZIP/Postal Code

53-413

Country

Poland

Facility Name

Local Institution - 0243

City

Bucharest

ZIP/Postal Code

022328

Country

Romania

Facility Name

Local Institution - 0200

City

Cluj-Napoca

ZIP/Postal Code

400015

Country

Romania

Facility Name

Local Institution - 0247

City

Cluj

ZIP/Postal Code

400015

Country

Romania

Facility Name

Local Institution - 0199

City

Craiova

ZIP/Postal Code

200542

Country

Romania

Facility Name

Local Institution - 0202

City

Iași

ZIP/Postal Code

700483

Country

Romania

Facility Name

Local Institution - 0065

City

Moscow

ZIP/Postal Code

117997

Country

Russian Federation

Facility Name

Local Institution - 0170

City

Novosibirsk

ZIP/Postal Code

630099

Country

Russian Federation

Facility Name

Local Institution - 0171

City

Saint-Petersburg

ZIP/Postal Code

194044

Country

Russian Federation

Facility Name

Local Institution - 0021

City

Saint-Petersburg

ZIP/Postal Code

198255

Country

Russian Federation

Facility Name

Local Institution - 0018

City

Singapore

State/Province

Central Singapore

ZIP/Postal Code

168583

Country

Singapore

Facility Name

Local Institution - 0017

City

Singapore

ZIP/Postal Code

119074

Country

Singapore

Facility Name

Local Institution - 0204

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Local Institution - 0206

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Local Institution - 0124

City

Caceres

ZIP/Postal Code

10003

Country

Spain

Facility Name

Local Institution - 0207

City

Cordoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

Local Institution - 0118

City

Lugo

ZIP/Postal Code

27003

Country

Spain

Facility Name

Local Institution - 0114

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Local Institution - 0205

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Local Institution - 0117

City

Sabadell

ZIP/Postal Code

08208

Country

Spain

Facility Name

Local Institution - 0161

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Local Institution - 0218

City

Chur

ZIP/Postal Code

7000

Country

Switzerland

Facility Name

Local Institution - 0219

City

Sankt Gallen

ZIP/Postal Code

9007

Country

Switzerland

Facility Name

Local Institution - 0225

City

Zuerich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

Local Institution - 0209

City

Ankara

ZIP/Postal Code

06590

Country

Turkey

Facility Name

Local Institution - 0210

City

Istanbul

ZIP/Postal Code

34098

Country

Turkey

Facility Name

Local Institution

City

Istanbul

ZIP/Postal Code

34214

Country

Turkey

Facility Name

Local Institution - 0075

City

Southampton

State/Province

Hampshire

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

Facility Name

Local Institution - 0063

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Facility Name

Local Institution - 0071

City

Northwood

ZIP/Postal Code

HA6 2RN

Country

United Kingdom

Facility Name

Local Institution - 0073

City

Preston

ZIP/Postal Code

PR2 9HT

Country

United Kingdom

Facility Name

Local Institution - 0072

City

Swansea

ZIP/Postal Code

SA2 8QA

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33526329

Citation

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.

Results Reference

derived

Links:

URL

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

Description

BMS Clinical Trial Information

URL

https://www.BMSStudyConnect.com

Description

BMS Clinical Trial Patient Recruiting

URL

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

Description

FDA Safety Alerts and Recalls

Learn more about this trial

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

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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)

Carcinoma, Renal Cell

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial