Back to resultsAn Investigational Immuno-therapy Study of Relatlimab Plus Nivolumab Compared to Various Standard-of-Care Therapies in Previously Treated Participants With Recurrent, Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
Primary Purpose
Gastric Cancer, Cancer of the Stomach, Stomach Cancer
Status
Withdrawn
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Relatlimab + Nivolumab
Nivolumab
Paclitaxel
Ramucirumab
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- Histologically or cytologically confirmed locally advanced or recurrent or metastatic GC or GEJ adenocarcinoma that is considered incurable by local therapies such as radiation or surgery
- Evidence of progressive disease (PD) on at least one prior platinum- and fluoropyrimidine-containing chemotherapy regimen
- Available tumor tissue for biomarker analysis
Exclusion Criteria:
- Must not have squamous cell or undifferentiated GC or GEJ
- Untreated known central nervous system (CNS) metastases
- Uncontrolled or significant cardiovascular disease
Other protocol defined inclusion/exclusion criteria could apply
Sites / Locations
- Local Institution
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Active Comparator
Experimental
Active Comparator
Experimental
Arm Label
Cohort A: relatlimab + nivolumab + paclitaxel
Cohort A: nivolumab + paclitaxel
Cohort A: ramucirumab + paclitaxel
Cohort B: relatlimab + nivolumab
Cohort B: nivolumab
Cohort C: relatlimab + nivolumab
Arm Description
Standard-of-care
Standard-of-care
Outcomes
Primary Outcome Measures
Overall response rate (ORR)
Secondary Outcome Measures
Incidence of adverse events (AEs)
Incidence of serious adverse events (SAEs)
Incidence of AEs leading to discontinuation
Incidence of deaths
Incidence of laboratory abnormalities
ORR
Cohort A1
Duration of response (DOR)
Progression free survival (PFS)
Overall survival (OS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03704077
Brief Title
An Investigational Immuno-therapy Study of Relatlimab Plus Nivolumab Compared to Various Standard-of-Care Therapies in Previously Treated Participants With Recurrent, Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
Official Title
A Randomized, Active-Controlled, Open-Label, Phase 2 Clinical Trial of BMS-986213, in Combination With Various Standard-of-Care Therapeutic Regimens, in Participants With Recurrent, Locally Advanced, or Metastatic Gastric Cancer (GC) or Gastroesophageal Junction (GEJ) Adenocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Replaced it with another clinical trial
Study Start Date
October 31, 2019 (Anticipated)
Primary Completion Date
February 27, 2022 (Anticipated)
Study Completion Date
September 30, 2024 (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
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the effectiveness of relatlimab plus nivolumab, alone or in combination with various standard-of-care treatments in participants with gastric cancer (GC) or gastroesophageal junction (GEJ) adenocarcinoma that has come back or spread to other places in the body after prior therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Cancer of the Stomach, Stomach Cancer, Gastroesophageal Junction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort A: relatlimab + nivolumab + paclitaxel
Arm Type
Experimental
Arm Title
Cohort A: nivolumab + paclitaxel
Arm Type
Experimental
Arm Title
Cohort A: ramucirumab + paclitaxel
Arm Type
Active Comparator
Arm Description
Standard-of-care
Arm Title
Cohort B: relatlimab + nivolumab
Arm Type
Experimental
Arm Title
Cohort B: nivolumab
Arm Type
Active Comparator
Arm Description
Standard-of-care
Arm Title
Cohort C: relatlimab + nivolumab
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Relatlimab + Nivolumab
Other Intervention Name(s)
BMS-986213
Intervention Description
Specified dose on specified days
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol, Onxal
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Ramucirumab
Other Intervention Name(s)
Cyramza
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Overall response rate (ORR)
Time Frame
Approximately 31 months
Secondary Outcome Measure Information:
Title
Incidence of adverse events (AEs)
Time Frame
Approximately 5 years
Title
Incidence of serious adverse events (SAEs)
Time Frame
Approximately 5 years
Title
Incidence of AEs leading to discontinuation
Time Frame
Approximately 5 years
Title
Incidence of deaths
Time Frame
Approximately 5 years
Title
Incidence of laboratory abnormalities
Time Frame
Approximately 5 years
Title
ORR
Description
Cohort A1
Time Frame
Approximately 5 years
Title
Duration of response (DOR)
Time Frame
Approximately 5 years
Title
Progression free survival (PFS)
Time Frame
Approximately 5 years
Title
Overall survival (OS)
Time Frame
Approximately 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Histologically or cytologically confirmed locally advanced or recurrent or metastatic GC or GEJ adenocarcinoma that is considered incurable by local therapies such as radiation or surgery
Evidence of progressive disease (PD) on at least one prior platinum- and fluoropyrimidine-containing chemotherapy regimen
Available tumor tissue for biomarker analysis
Exclusion Criteria:
Must not have squamous cell or undifferentiated GC or GEJ
Untreated known central nervous system (CNS) metastases
Uncontrolled or significant cardiovascular disease
Other protocol defined inclusion/exclusion criteria could 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
City
Daphne
State/Province
Alabama
ZIP/Postal Code
36526
Country
United States
Facility Name
Local Institution
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Local Institution
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Local Institution
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Local Institution
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
Local Institution
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Local Institution
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Local Institution
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Local Institution
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Local Institution
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Local Institution
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Local Institution
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Local Institution
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Local Institution
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Local Institution
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Local Institution
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Local Institution
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58102
Country
United States
Facility Name
Local Institution
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Local Institution
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Local Institution
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
Facility Name
Local Institution
City
Viedma
State/Province
RIO Negro
ZIP/Postal Code
8500
Country
Argentina
Facility Name
Local Institution
City
Buenos Aires
ZIP/Postal Code
1093
Country
Argentina
Facility Name
Local Institution
City
Caba
ZIP/Postal Code
1199
Country
Argentina
Facility Name
Local Institution
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Local Institution
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Local Institution
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Local Institution
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Local Institution
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
Local Institution
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Local Institution
City
Bedford Park
ZIP/Postal Code
5024
Country
Australia
Facility Name
Local Institution
City
Murdoch
ZIP/Postal Code
6150
Country
Australia
Facility Name
Local Institution
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60430-230
Country
Brazil
Facility Name
Local Institution
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-090
Country
Brazil
Facility Name
Local Institution
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Local Institution
City
Barretos
State/Province
SAO Paulo
ZIP/Postal Code
14780-070
Country
Brazil
Facility Name
Local Institution
City
Jau
State/Province
SAO Paulo
ZIP/Postal Code
17210-080
Country
Brazil
Facility Name
Local Institution
City
Rio de Janeiro
ZIP/Postal Code
22793-080
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Local Institution
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Local Institution
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Local Institution
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Local Institution
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Local Institution
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
8330024
Country
Chile
Facility Name
Local Institution
City
Santiago
State/Province
Metropolitana
Country
Chile
Facility Name
Local Institution
City
Medellin
Country
Colombia
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Local Institution
City
Cologne
ZIP/Postal Code
50937
Country
Germany
Facility Name
Local Institution
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Local Institution
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Local Institution
City
Frankfurt am Main
ZIP/Postal Code
60488
Country
Germany
Facility Name
Local Institution
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Local Institution
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Facility Name
Local Institution
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Local Institution
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Local Institution
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Local Institution
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Local Institution
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Local Institution
City
Paderborn
ZIP/Postal Code
33098
Country
Germany
Facility Name
Local Institution
City
Reutlingen
ZIP/Postal Code
72764
Country
Germany
Facility Name
Local Institution
City
Wiesbaden
ZIP/Postal Code
65199
Country
Germany
Facility Name
Local Institution
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Local Institution
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Local Institution
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Local Institution
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
Facility Name
Local Institution
City
Tuxtla Gutierrez
State/Province
Chiapas
ZIP/Postal Code
29029
Country
Mexico
Facility Name
Local Institution
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Local Institution
City
ZONA Centro. LEON
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Local Institution
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97134
Country
Mexico
Facility Name
Local Institution
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Local Institution
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Local Institution
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Local Institution
City
Rio Piedras
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
Local Institution
City
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Facility Name
Local Institution
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Local Institution
City
Craiova
ZIP/Postal Code
200347
Country
Romania
Facility Name
Local Institution
City
Floresti
ZIP/Postal Code
407280
Country
Romania
Facility Name
Local Institution
City
Badajoz
ZIP/Postal Code
06006
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Local Institution
City
Valencia
ZIP/Postal Code
46026
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual patient level data from this study may be shared with qualified researchers, upon request, following the timelines and process detailed on https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.html
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
An Investigational Immuno-therapy Study of Relatlimab Plus Nivolumab Compared to Various Standard-of-Care Therapies in Previously Treated Participants With Recurrent, Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
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