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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001070-20 | EudraCT Number |
Not provided
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Replaced it with another clinical trial
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: relatlimab + nivolumab + paclitaxel | Experimental |
| |
| Cohort A: nivolumab + paclitaxel | Experimental |
| |
| Cohort A: ramucirumab + paclitaxel | Active Comparator | Standard-of-care |
|
| Cohort B: relatlimab + nivolumab | Experimental |
| |
| Cohort B: nivolumab | Active Comparator | Standard-of-care |
|
| Cohort C: relatlimab + nivolumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relatlimab + Nivolumab | Biological | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | Approximately 31 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Approximately 5 years | |
| Incidence of serious adverse events (SAEs) | Approximately 5 years | |
| Incidence of AEs leading to discontinuation |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Daphne | Alabama | 36526 | United States | ||
| Local Institution |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
Not provided
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
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|
| Nivolumab | Biological | Specified dose on specified days |
|
|
| Paclitaxel | Drug | Specified dose on specified days |
|
|
| Ramucirumab | Drug | Specified dose on specified days |
|
|
| Approximately 5 years |
| Incidence of deaths | Approximately 5 years |
| Incidence of laboratory abnormalities | Approximately 5 years |
| ORR | Cohort A1 | Approximately 5 years |
| Duration of response (DOR) | Approximately 5 years |
| Progression free survival (PFS) | Approximately 5 years |
| Overall survival (OS) | Approximately 5 years |
| Bakersfield |
| California |
| 93309 |
| United States |
| Local Institution | Fullerton | California | 92835 | United States |
| Local Institution | Los Angeles | California | 90095 | United States |
| Local Institution | Redondo Beach | California | 90277 | United States |
| Local Institution | Santa Barbara | California | 93105 | United States |
| Local Institution | Aurora | Colorado | 80045 | United States |
| Local Institution | Lakewood | Colorado | 80228 | United States |
| Local Institution | Miami | Florida | 33176 | United States |
| Local Institution | Tampa | Florida | 33612 | United States |
| Local Institution | Marietta | Georgia | 30060 | United States |
| Local Institution | Boston | Massachusetts | 02215 | United States |
| Local Institution | St Louis | Missouri | 63110 | United States |
| Local Institution | New Brunswick | New Jersey | 08009 | United States |
| Local Institution | Chapel Hill | North Carolina | 27599 | United States |
| Local Institution | Charlotte | North Carolina | 28204 | United States |
| Local Institution | Fargo | North Dakota | 58102 | United States |
| Local Institution | Allentown | Pennsylvania | 18103 | United States |
| Local Institution | Sioux Falls | South Dakota | 57104 | United States |
| Local Institution | Vancouver | Washington | 98684 | United States |
| Local Institution | Viedma | Río Negro Province | 8500 | Argentina |
| Local Institution | Buenos Aires | 1093 | Argentina |
| Local Institution | Buenos Aires | 1426 | Argentina |
| Local Institution | CABA | 1199 | Argentina |
| Local Institution | Córdoba | 5000 | Argentina |
| Local Institution | Westmead | New South Wales | 2145 | Australia |
| Local Institution | Heidelberg | Victoria | 3084 | Australia |
| Local Institution | Malvern | Victoria | 3144 | Australia |
| Local Institution | Melbourne | Victoria | 3000 | Australia |
| Local Institution | Bedford Park | 5024 | Australia |
| Local Institution | Murdoch | 6150 | Australia |
| Local Institution | Fortaleza | Ceará | 60430-230 | Brazil |
| Local Institution | Belo Horizonte | Minas Gerais | 30130-090 | Brazil |
| Local Institution | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Local Institution | Barretos | São Paulo | 14780-070 | Brazil |
| Local Institution | Jaú | São Paulo | 17210-080 | Brazil |
| Local Institution | Rio de Janeiro | 22793-080 | Brazil |
| Local Institution | São Paulo | 01246-000 | Brazil |
| Local Institution | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Local Institution | Hamilton | Ontario | L8V 5C2 | Canada |
| Local Institution | Ottawa | Ontario | K1H 8L6 | Canada |
| Local Institution | Toronto | Ontario | M5B 1W8 | Canada |
| Local Institution | Toronto | Ontario | M5G 2M9 | Canada |
| Local Institution | Montreal | Quebec | H4J 1C5 | Canada |
| Local Institution | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Local Institution | Santiago | Santiago Metropolitan | 8330024 | Chile |
| Local Institution | Santiago | Santiago Metropolitan | Chile |
| Local Institution | Medellín | Colombia |
| Local Institution | Berlin | 13125 | Germany |
| Local Institution | Cologne | 50937 | Germany |
| Local Institution | Erlangen | 91054 | Germany |
| Local Institution | Essen | 45147 | Germany |
| Local Institution | Frankfurt am Main | 60488 | Germany |
| Local Institution | Freiburg im Breisgau | 79106 | Germany |
| Local Institution | Hamburg | 22763 | Germany |
| Local Institution | Hanover | 30625 | Germany |
| Local Institution | Jena | 07747 | Germany |
| Local Institution | Mainz | 55131 | Germany |
| Local Institution | Mannheim | 68167 | Germany |
| Local Institution | Marburg | 35043 | Germany |
| Local Institution | Paderborn | 33098 | Germany |
| Local Institution | Reutlingen | 72764 | Germany |
| Local Institution | Wiesbaden | 65199 | Germany |
| Local Institution | Bergamo | 24127 | Italy |
| Local Institution | Milan | 20133 | Italy |
| Local Institution | Naples | 80131 | Italy |
| Local Institution | Reggio Emilia | 42100 | Italy |
| Local Institution | Tuxtla Gutiérrez | Chiapas | 29029 | Mexico |
| Local Institution | ZONA Centro. LEON | Guanajuato | 37000 | Mexico |
| Local Institution | Mexico City | Mexico City | 14080 | Mexico |
| Local Institution | Mérida | Yucatán | 97134 | Mexico |
| Local Institution | Aguascalientes | 20230 | Mexico |
| Local Institution | Lisbon | 1649-035 | Portugal |
| Local Institution | Porto | 4200-072 | Portugal |
| Local Institution | Rio Piedras | 00935 | Puerto Rico |
| Local Institution | Bucharest | 022328 | Romania |
| Local Institution | Cluj-Napoca | 400015 | Romania |
| Local Institution | Craiova | 200347 | Romania |
| Local Institution | Floreşti | 407280 | Romania |
| Local Institution | Badajoz | 06006 | Spain |
| Local Institution | Madrid | 28007 | Spain |
| Local Institution | Madrid | 28034 | Spain |
| Local Institution | Madrid | 28050 | Spain |
| Local Institution | Valencia | 46026 | Spain |
| FDA Safety Alerts and Recalls | View source |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| C000721227 | relatlimab |
| D000077594 | Nivolumab |
| D017239 | Paclitaxel |
| D000096662 | Ramucirumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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