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Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer (CheckMate649)

Primary Purpose

Gastric Cancer, Gastroesophageal Junction Cancer, Esophageal Adenocarcinoma

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Nivolumab

Ipilimumab

Oxaliplatin

Capecitabine

Leucovorin

Fluorouracil

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

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

Inclusion Criteria:

Male or Female at least 18 years of age
Must have gastric cancer or gastroesophageal junction cancer that cannot be operated on and that is advanced or has spread out
Did not receive neoadjuvant or adjuvant treatment (chemotherapy, radiotherapy, or both) for their disease within the last 6 months
Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
Must agree to provide tumor tissue sample, either from a previous surgery or biopsy within 6 months or fresh, prior to the start of treatment in this study

Exclusion Criteria:

Presence of tumor cells in the brain or spinal cord that have not been treated
Active known or suspected autoimmune disease
Any serious or uncontrolled medical disorder or active infection
Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
Any positive test result for hepatitis B or C indicating acute or chronic infection

Other protocol-defined inclusion/exclusion criteria apply

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Nivolumab + Ipilimumab

XELOX (Oxaliplatin + Capecitabine)

FOLFOX (Oxaliplatin + Leucovorin + Fluorouracil)

Nivolumab + XELOX

Nivolumab + FOLFOX

Arm Description

Nivolumab + Ipilimumab for 4 doses, followed by Nivolumab monotherapy Enrollment is closed for this arm

Outcomes

Primary Outcome Measures

Overall Survival (OS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5

Overall survival (OS), defined as the time from randomization to the time of death, in participants treated with Nivolumab plus Chemotherapy vs Chemotherapy with PD-L1 CPS (combined positive score) ≥ 5. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.

Progression Free Survival (PFS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5

Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented PD or death due to any cause. PD is determined by blinded independent committee review (BICR) per RECIST1.1 criteria in participants treated with Nivolumab plus Chemotherapy vs Chemotherapy with PD-L1 CPS ≥ 5. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking in reference the smallest sum on study that also demonstrated an absolute increase of at least 5 mm. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.

Secondary Outcome Measures

OS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy

Overall survival (OS), defined as the time from randomization to the time of death, in participants treated with Nivolumab plus Chemotherapy vs Chemotherapy with PD-L1 CPS ≥ 1, 10, and all randomized participants. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.

PFS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy

Progression free survival (PFS), defined as the time from randomization to the date of the first documented progressive disease (PD) or death due to any cause, in participants treated with Nivolumab plus Chemotherapy vs Chemotherapy by BICR per RECIST1.1 in participants with PD-L1 CPS ≥ 10, 1, or all randomized subjects. Progreessive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking in reference the smallest sum on study that also demonstrated an absolute increase of at least 5 mm. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.

Objective Response Rate

Objective response rate (ORR) as assessed by BICR in participants with PD-L1 CPS ≥ 10, 5, 1, or all randomized participants. ORR is a percentage of participants determined by the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of measurable participants with target lesion at baseline. BOR is defined as the best response designation as determined by the BICR, recorded between the date of randomization and the date of objectively documented progression (per RECIST 1.1 as determined by the BICR) or the date of subsequent anti-cancer therapy, whichever occurs first. CR is defined as the disappearance of all target lesions. PR is define as at 30% decrease in the sum of diameters of target lesions. The 806 chemotherapy treated participants are split into two separate arms (Arm 2a and Arm 2b) to act as comparison groups to the other treatment arms.

OS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy

Overall survival (OS), defined as the time from randomization to the time of death, in participants treated with Nivolumab plus Ipilimumab vs Chemotherapy with PD-L1 CPS (combined positive score) ≥ 1, 5, 10, and all randomized participants. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.

Time to Symptom Deterioration (TTSD)

TTSD is defined as the the time from randomization until a clinically meaningful decline from baseline in Gastric Cancer Subscale (GaCS) score. A clinically meaningful deterioration is defined as a reduction of 8.2 points in the GaCS score. Subjects who do not deteriorate will be censored at the time of their last GACS assessment. Subjects without baseline GaCS assessment will be censored on the randomization date. Those with baseline GaCS, who do not have any GaCS assessments after randomization will be censored on the day after randomization.

PFS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy

Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented PD or death due to any cause. PD is determined by blinded independent committee review (BICR) per RECIST1.1 criteria in participants treated with Nivolumab plus Ipilumab vs Chemotherapy with PD-L1 CPS ≥ 10, 5, 1 or all randomized participants. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking in reference the smallest sum on study that also demonstrated an absolute increase of at least 5 mm. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.

Full Information

NCT ID

NCT02872116

First Posted

August 16, 2016

Last Updated

October 19, 2023

Sponsor

Bristol-Myers Squibb

Collaborators

Ono Pharmaceutical Co. Ltd

1. Study Identification

Unique Protocol Identification Number

NCT02872116

Brief Title

Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer

Acronym

CheckMate649

Official Title

A Randomized, Multicenter, Open-Label, Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab in Combination With Oxaliplatin Plus Fluoropyrimidine Versus Oxaliplatin Plus Fluoropyrimidine in Subjects With Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 12, 2016 (Actual)

Primary Completion Date

May 27, 2020 (Actual)

Study Completion Date

May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

Collaborators

Ono Pharmaceutical Co. Ltd

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 main purpose of this study is to compare how long patients with gastric or gastroesophageal junction cancer live after receiving nivolumab and ipilimumab or nivolumab and chemotherapy compared with patients receiving chemotherapy alone.

6. Conditions and Keywords

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

Gastric Cancer, Gastroesophageal Junction Cancer, Esophageal Adenocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2031 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nivolumab + Ipilimumab

Arm Type

Experimental

Arm Description

Nivolumab + Ipilimumab for 4 doses, followed by Nivolumab monotherapy Enrollment is closed for this arm

Arm Title

XELOX (Oxaliplatin + Capecitabine)

Arm Type

Active Comparator

Arm Title

FOLFOX (Oxaliplatin + Leucovorin + Fluorouracil)

Arm Type

Active Comparator

Arm Title

Nivolumab + XELOX

Arm Type

Experimental

Arm Title

Nivolumab + FOLFOX

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Nivolumab

Other Intervention Name(s)

Opdivo, BMS-936558

Intervention Description

Specified dose on specified days

Intervention Type

Drug

Intervention Name(s)

Ipilimumab

Other Intervention Name(s)

Yervoy, BMS-734016

Intervention Description

Specified dose on specified days

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Intervention Description

Specified dose on specified days

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Intervention Description

Specified dose on specified days

Intervention Type

Drug

Intervention Name(s)

Leucovorin

Intervention Description

Specified dose on specified days

Intervention Type

Drug

Intervention Name(s)

Fluorouracil

Intervention Description

Specified dose on specified days

Primary Outcome Measure Information:

Title

Overall Survival (OS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5

Description

Time Frame

From the date of randomization up to the date of death, up to approximately 17 months

Title

Progression Free Survival (PFS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5

Description

Time Frame

From randomization to the date of the first documented progressive disease (PD) per BICR or death due to any cause (up to approximately 10 months)

Secondary Outcome Measure Information:

Title

OS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy

Description

Time Frame

From the date of randomization up to the date of death, up to approximately 17 months

Title

PFS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy

Description

Time Frame

From randomization to the date of the first documented progressive disease (PD) per BICR or death due to any cause (up to approximately 10 months)

Title

Objective Response Rate

Description

Time Frame

From randomization to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 43 months)

Title

OS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy

Description

Time Frame

From the date of randomization up to the date of death, up to approximately 14 months

Title

Time to Symptom Deterioration (TTSD)

Description

Time Frame

From randomization until a clinically meaningful decline from baseline in GaCS score

Title

PFS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy

Description

Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented PD or death due to any cause. PD is determined by blinded independent committee review (BICR) per RECIST1.1 criteria in participants treated with Nivolumab plus Ipilumab vs Chemotherapy with PD-L1 CPS ≥ 10, 5, 1 or all randomized participants. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking in reference the smallest sum on study that also demonstrated an absolute increase of at least 5 mm. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.

Time Frame

From randomization to the date of the first documented progressive disease (PD) per BICR or death due to any cause (up to approximately 9 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or Female at least 18 years of age Must have gastric cancer or gastroesophageal junction cancer that cannot be operated on and that is advanced or has spread out Did not receive neoadjuvant or adjuvant treatment (chemotherapy, radiotherapy, or both) for their disease within the last 6 months Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work Must agree to provide tumor tissue sample, either from a previous surgery or biopsy within 6 months or fresh, prior to the start of treatment in this study Exclusion Criteria: Presence of tumor cells in the brain or spinal cord that have not been treated Active known or suspected autoimmune disease Any serious or uncontrolled medical disorder or active infection Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) Any positive test result for hepatitis B or C indicating acute or chronic infection 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 - 0005

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

California Pacific Medical Center Research Institute

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

Local Institution - 0066

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Local Institution - 0151

City

Denver

State/Province

Colorado

ZIP/Postal Code

80218

Country

United States

Facility Name

Local Institution - 0136

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

Florida Cancer Specialists S.

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33901

Country

United States

Facility Name

Local Institution - 0147

City

Miami

State/Province

Florida

ZIP/Postal Code

33176

Country

United States

Facility Name

Florida Cancer Specialists

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33705

Country

United States

Facility Name

Local Institution - 0179

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

Local Institution - 0219

City

Arlington Heights

State/Province

Illinois

ZIP/Postal Code

60005

Country

United States

Facility Name

Local Institution - 0120

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Local Institution - 0021

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21224

Country

United States

Facility Name

Local Institution - 0002

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Local Institution - 0135

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Local Institution - 0003

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Local Institution - 0138

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

Local Institution - 0186

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Local Institution - 0146

City

Eugene

State/Province

Oregon

ZIP/Postal Code

97401

Country

United States

Facility Name

Lehigh Valley Health Network

City

Allentown

State/Province

Pennsylvania

ZIP/Postal Code

18105

Country

United States

Facility Name

Local Institution - 0065

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15224

Country

United States

Facility Name

Local Institution - 0104

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Local Institution - 0140

City

Bedford

State/Province

Texas

ZIP/Postal Code

76022

Country

United States

Facility Name

Local Institution - 0143

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Local Institution - 0213

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Local Institution - 0004

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Texas Oncology-Plano East

City

Plano

State/Province

Texas

ZIP/Postal Code

75075-7787

Country

United States

Facility Name

Local Institution - 0150

City

Newport News

State/Province

Virginia

ZIP/Postal Code

23606

Country

United States

Facility Name

Local Institution - 0030

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

1426

Country

Argentina

Facility Name

Local Institution - 0028

City

Capital Federal

State/Province

Buenos Aires

ZIP/Postal Code

1264

Country

Argentina

Facility Name

Local Institution - 0029

City

Capital Federal

State/Province

Buenos Aires

ZIP/Postal Code

1280

Country

Argentina

Facility Name

Local Institution - 0183

City

Viedma

State/Province

RIO Negro

ZIP/Postal Code

8500

Country

Argentina

Facility Name

Local Institution - 0026

City

San Miguel De Tucuman

State/Province

Tucuman

ZIP/Postal Code

4000

Country

Argentina

Facility Name

Local Institution - 0027

City

Cordoba

ZIP/Postal Code

5000

Country

Argentina

Facility Name

Local Institution - 0184

City

La Rioja

ZIP/Postal Code

5300

Country

Argentina

Facility Name

Local Institution - 0202

City

Blacktown

State/Province

New South Wales

ZIP/Postal Code

2148

Country

Australia

Facility Name

Local Institution - 0100

City

Gosford

State/Province

New South Wales

ZIP/Postal Code

2250

Country

Australia

Facility Name

Local Institution - 0190

City

Southport

State/Province

Queensland

ZIP/Postal Code

4215

Country

Australia

Facility Name

Local Institution - 0101

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

Local Institution - 0103

City

Ballarat

State/Province

Victoria

ZIP/Postal Code

3350

Country

Australia

Facility Name

Local Institution - 0102

City

Shepparton

State/Province

Victoria

ZIP/Postal Code

3630

Country

Australia

Facility Name

Local Institution - 0214

City

St Albans

State/Province

Victoria

ZIP/Postal Code

3021

Country

Australia

Facility Name

Local Institution - 0099

City

Perth

State/Province

Western Australia

ZIP/Postal Code

6150

Country

Australia

Facility Name

Local Institution - 0053

City

Salvador

State/Province

Bahia

ZIP/Postal Code

41950-610

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 - 0047

City

Porto Alegre

State/Province

RIO Grande DO SUL

ZIP/Postal Code

90035-903

Country

Brazil

Facility Name

Local Institution - 0048

City

Barretos

State/Province

Sao Paulo

ZIP/Postal Code

14784-400

Country

Brazil

Facility Name

Local Institution - 0054

City

Sao Paulo

ZIP/Postal Code

01246-000

Country

Brazil

Facility Name

Local Institution - 0035

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

Local Institution - 0036

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4L6

Country

Canada

Facility Name

Local Institution - 0067

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

Local Institution - 0052

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2X 3E4

Country

Canada

Facility Name

Local Institution - 0196

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Facility Name

Local Institution - 0051

City

Quebec City

State/Province

Quebec

ZIP/Postal Code

G1J 1Z4

Country

Canada

Facility Name

Local Institution - 0068

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 5N4

Country

Canada

Facility Name

Local Institution - 0034

City

Trois-Rivieres

State/Province

Quebec

ZIP/Postal Code

G8Z 3R9

Country

Canada

Facility Name

Local Institution - 0032

City

Temuco

State/Province

Araucania

ZIP/Postal Code

4800827

Country

Chile

Facility Name

Local Institution - 0057

City

Santiago

State/Province

Metropolitana

ZIP/Postal Code

8320000

Country

Chile

Facility Name

Local Institution - 0031

City

Santiago

State/Province

Metropolitana

Country

Chile

Facility Name

Local Institution - 0058

City

Independencia

State/Province

Santiago

Country

Chile

Facility Name

Local Institution - 0033

City

Vina Del Mar

State/Province

Valparaiso

ZIP/Postal Code

2540364

Country

Chile

Facility Name

Local Institution - 0176

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100001

Country

China

Facility Name

Local Institution - 0178

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100032

Country

China

Facility Name

Local Institution - 0171

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100142

Country

China

Facility Name

Local Institution - 0185

City

Fuzhou

State/Province

Fujian

ZIP/Postal Code

350000

Country

China

Facility Name

Local Institution - 0166

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Facility Name

Local Institution - 0160

City

Harbin

State/Province

Heilongjiang

ZIP/Postal Code

150081

Country

China

Facility Name

Local Institution - 0159

City

Zhengzhou

State/Province

Henan

ZIP/Postal Code

450008

Country

China

Facility Name

Local Institution - 0173

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410013

Country

China

Facility Name

Local Institution - 0158

City

Changzhou

State/Province

Jiangsu

ZIP/Postal Code

213003

Country

China

Facility Name

Local Institution - 0187

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210000

Country

China

Facility Name

Local Institution - 0154

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210002

Country

China

Facility Name

Local Institution - 0156

City

Changchun

State/Province

Jilin

ZIP/Postal Code

130012

Country

China

Facility Name

Local Institution - 0155

City

Changchun

State/Province

Jilin

ZIP/Postal Code

130021

Country

China

Facility Name

Local Institution - 0181

City

Shenyang

State/Province

Liaoning

ZIP/Postal Code

110046

Country

China

Facility Name

Local Institution - 0182

City

Qingdao

State/Province

Shandong

ZIP/Postal Code

266061

Country

China

Facility Name

Local Institution - 0165

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Name

Local Institution - 0175

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Name

Local Institution - 0167

City

Urumqi

State/Province

Xinjiang

ZIP/Postal Code

830011

Country

China

Facility Name

Local Institution - 0161

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310009

Country

China

Facility Name

Local Institution - 0168

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310022

Country

China

Facility Name

Local Institution - 0174

City

Hangzhou

ZIP/Postal Code

310016

Country

China

Facility Name

Local Institution - 0172

City

Tianjin

ZIP/Postal Code

300060

Country

China

Facility Name

Local Institution - 0025

City

Bogota

State/Province

Cundinamarca

ZIP/Postal Code

Country

Colombia

Facility Name

Local Institution - 0022

City

Bogota

ZIP/Postal Code

Country

Colombia

Facility Name

Local Institution - 0024

City

Pasto

ZIP/Postal Code

Country

Colombia

Facility Name

Local Institution - 0200

City

Brno

ZIP/Postal Code

625 00

Country

Czechia

Facility Name

Local Institution - 0197

City

Brno

ZIP/Postal Code

656 53

Country

Czechia

Facility Name

Local Institution - 0080

City

Caen

ZIP/Postal Code

14000

Country

France

Facility Name

Local Institution - 0081

City

Dijon

ZIP/Postal Code

21000

Country

France

Facility Name

Local Institution - 0077

City

Lille

ZIP/Postal Code

59000

Country

France

Facility Name

Local Institution - 0083

City

Montpellier

ZIP/Postal Code

34090

Country

France

Facility Name

Local Institution - 0113

City

Nantes

ZIP/Postal Code

44000

Country

France

Facility Name

Local Institution - 0079

City

Nice Cedex 2

ZIP/Postal Code

06189

Country

France

Facility Name

Local Institution - 0078

City

Paris

ZIP/Postal Code

75012

Country

France

Facility Name

Local Institution - 0119

City

Plérin

ZIP/Postal Code

22190

Country

France

Facility Name

Local Institution - 0094

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Local Institution - 0095

City

Cologne

ZIP/Postal Code

50937

Country

Germany

Facility Name

Local Institution - 0089

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Local Institution - 0188

City

Dusseldorf

ZIP/Postal Code

40225

Country

Germany

Facility Name

Local Institution - 0091

City

Essen

ZIP/Postal Code

45122

Country

Germany

Facility Name

Local Institution - 0096

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Local Institution - 0093

City

Hamburg

ZIP/Postal Code

20251

Country

Germany

Facility Name

Local Institution - 0092

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Local Institution - 0149

City

Muenchen

ZIP/Postal Code

81675

Country

Germany

Facility Name

Local Institution - 0017

City

Nea Kifissia

State/Province

Attikí

ZIP/Postal Code

14564

Country

Greece

Facility Name

Local Institution - 0056

City

Athens

ZIP/Postal Code

11526

Country

Greece

Facility Name

Local Institution - 0019

City

Ioannina

ZIP/Postal Code

45500

Country

Greece

Facility Name

Local Institution - 0018

City

Patras

ZIP/Postal Code

26504

Country

Greece

Facility Name

Local Institution - 0191

City

Hong Kong

ZIP/Postal Code

Country

Hong Kong

Facility Name

Local Institution - 0195

City

Hong Kong

ZIP/Postal Code

Country

Hong Kong

Facility Name

Local Institution - 0008

City

Budapest

ZIP/Postal Code

1083

Country

Hungary

Facility Name

Local Institution - 0007

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

Local Institution - 0108

City

Debrecen

ZIP/Postal Code

Country

Hungary

Facility Name

Local Institution - 0118

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

Local Institution - 0116

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Local Institution - 0115

City

Petach Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Local Institution - 0117

City

Ramat-gan

ZIP/Postal Code

52621

Country

Israel

Facility Name

Local Institution - 0114

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Local Institution - 0062

City

Bergamo

ZIP/Postal Code

24127

Country

Italy

Facility Name

Local Institution - 0205

City

Modena

ZIP/Postal Code

41124

Country

Italy

Facility Name

Local Institution - 0061

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Local Institution - 0063

City

Pisa

ZIP/Postal Code

56126

Country

Italy

Facility Name

Local Institution - 0059

City

Roma

ZIP/Postal Code

00168

Country

Italy

Facility Name

Local Institution - 0064

City

San Giovanni Rotondo

ZIP/Postal Code

71013

Country

Italy

Facility Name

Local Institution - 0130

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

4648681

Country

Japan

Facility Name

Local Institution - 0128

City

Chiba-shi

State/Province

Chiba

ZIP/Postal Code

260-8717

Country

Japan

Facility Name

Local Institution - 0125

City

Kashiwa

State/Province

Chiba

ZIP/Postal Code

277-8577

Country

Japan

Facility Name

Local Institution - 0137

City

Sapporo-shi

State/Province

Hokkaido

ZIP/Postal Code

0608648

Country

Japan

Facility Name

Local Institution - 0127

City

Kita-Gun

State/Province

Kagawa

ZIP/Postal Code

7610793

Country

Japan

Facility Name

Local Institution - 0124

City

Suita-shi

State/Province

Osaka

ZIP/Postal Code

565-0871

Country

Japan

Facility Name

Local Institution - 0123

City

Kitaadachi-gun

State/Province

Saitama

ZIP/Postal Code

3620806

Country

Japan

Facility Name

Local Institution - 0126

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

1040045

Country

Japan

Facility Name

Local Institution - 0122

City

Minato-ku

State/Province

Tokyo

ZIP/Postal Code

1058470

Country

Japan

Facility Name

Local Institution - 0129

City

Tokyo

ZIP/Postal Code

1358550

Country

Japan

Facility Name

Local Institution - 0132

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Local Institution - 0131

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Local Institution - 0215

City

Mexico City

State/Province

Distrito Federal

ZIP/Postal Code

03100

Country

Mexico

Facility Name

Local Institution - 0217

City

Toluca

State/Province

Estado DE Mexico

ZIP/Postal Code

50120

Country

Mexico

Facility Name

Local Institution - 0216

City

Queretaro

ZIP/Postal Code

76090

Country

Mexico

Facility Name

Local Institution - 0189

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Local Institution - 0039

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Local Institution - 0037

City

Lima

ZIP/Postal Code

LIMA 31

Country

Peru

Facility Name

Local Institution - 0139

City

Lima

ZIP/Postal Code

Lima 41

Country

Peru

Facility Name

Local Institution - 0016

City

Lublin

ZIP/Postal Code

20-081

Country

Poland

Facility Name

Local Institution - 0013

City

Tarnobrzeg

ZIP/Postal Code

39-400

Country

Poland

Facility Name

Local Institution - 0014

City

Warszawa

ZIP/Postal Code

02-034

Country

Poland

Facility Name

Local Institution - 0043

City

Lisboa

ZIP/Postal Code

1649-035

Country

Portugal

Facility Name

Local Institution - 0210

City

Porto

ZIP/Postal Code

4200-072

Country

Portugal

Facility Name

Local Institution - 0012

City

Baia Mare

State/Province

Jud Maramures

ZIP/Postal Code

430291

Country

Romania

Facility Name

Local Institution - 0040

City

Bucharest

ZIP/Postal Code

022328

Country

Romania

Facility Name

Local Institution - 0042

City

Cluj-Napoca

ZIP/Postal Code

400015

Country

Romania

Facility Name

Local Institution - 0041

City

Craiova

ZIP/Postal Code

200542

Country

Romania

Facility Name

Local Institution - 0055

City

Suceava

ZIP/Postal Code

720237

Country

Romania

Facility Name

Local Institution - 0071

City

Chelyabinsk

ZIP/Postal Code

454048

Country

Russian Federation

Facility Name

Local Institution - 0086

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Local Institution - 0069

City

Moscow

ZIP/Postal Code

121309

Country

Russian Federation

Facility Name

Local Institution - 0105

City

Moscow

ZIP/Postal Code

125284

Country

Russian Federation

Facility Name

Local Institution - 0085

City

St. Petersburg

ZIP/Postal Code

198255

Country

Russian Federation

Facility Name

Local Institution - 0194

City

Singapore

ZIP/Postal Code

119228

Country

Singapore

Facility Name

Local Institution - 0193

City

Singapore

ZIP/Postal Code

169610

Country

Singapore

Facility Name

Local Institution - 0050

City

Badajoz

ZIP/Postal Code

06006

Country

Spain

Facility Name

Local Institution - 0209

City

Badalona-barcelona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Local Institution - 0044

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Local Institution - 0049

City

Pozuelo De Alarcon, Madrid

ZIP/Postal Code

28223

Country

Spain

Facility Name

Local Institution - 0045

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Facility Name

Local Institution - 0212

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Facility Name

Local Institution - 0148

City

Tainan

ZIP/Postal Code

70403

Country

Taiwan

Facility Name

Local Institution - 0133

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

Facility Name

Local Institution - 0134

City

Taoyuan County

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Local Institution - 0203

City

Ankara

ZIP/Postal Code

06800

Country

Turkey

Facility Name

Local Institution - 0211

City

Ankara

ZIP/Postal Code

06800

Country

Turkey

Facility Name

Local Institution - 0201

City

Antalya

ZIP/Postal Code

07070

Country

Turkey

Facility Name

Local Institution - 0208

City

Diyarbakır

ZIP/Postal Code

21280

Country

Turkey

Facility Name

Local Institution - 0207

City

Edrine

ZIP/Postal Code

22010

Country

Turkey

Facility Name

Local Institution - 0074

City

London

State/Province

Greater London

ZIP/Postal Code

SW3 6JJ

Country

United Kingdom

Facility Name

Local Institution - 0073

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Facility Name

Local Institution - 0076

City

Nottingham

State/Province

Nottinghamshire

ZIP/Postal Code

NG5 1PB

Country

United Kingdom

Facility Name

Local Institution - 0075

City

Sutton

State/Province

Surrey

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

Facility Name

Local Institution - 0072

City

Southampton

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

34102137

Citation

Janjigian YY, Shitara K, Moehler M, Garrido M, Salman P, Shen L, Wyrwicz L, Yamaguchi K, Skoczylas T, Campos Bragagnoli A, Liu T, Schenker M, Yanez P, Tehfe M, Kowalyszyn R, Karamouzis MV, Bruges R, Zander T, Pazo-Cid R, Hitre E, Feeney K, Cleary JM, Poulart V, Cullen D, Lei M, Xiao H, Kondo K, Li M, Ajani JA. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): a randomised, open-label, phase 3 trial. Lancet. 2021 Jul 3;398(10294):27-40. doi: 10.1016/S0140-6736(21)00797-2. Epub 2021 Jun 5.

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/s/US/English/USenHome

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

Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer

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Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer (CheckMate649)

Gastric Cancer, Gastroesophageal Junction Cancer, Esophageal Adenocarcinoma

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