Gastric Cancer Clinical Trial
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
| Verified date | May 2020 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | September 30, 2024 |
| Est. primary completion date | February 27, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Local Institution | Buenos Aires | |
| Argentina | Local Institution | Caba | |
| Argentina | Local Institution | Ciudad Autonoma de Buenos Aires | |
| Argentina | Local Institution | Cordoba | |
| Argentina | Local Institution | Viedma | RIO Negro |
| Australia | Local Institution | Bedford Park | |
| Australia | Local Institution | Heidelberg | Victoria |
| Australia | Local Institution | Malvern | Victoria |
| Australia | Local Institution | Melbourne | Victoria |
| Australia | Local Institution | Murdoch | |
| Australia | Local Institution | Westmead | New South Wales |
| Brazil | Local Institution | Barretos | SAO Paulo |
| Brazil | Local Institution | Belo Horizonte | Minas Gerais |
| Brazil | Local Institution | Fortaleza | Ceara |
| Brazil | Local Institution | Jau | SAO Paulo |
| Brazil | Local Institution | Porto Alegre | RIO Grande DO SUL |
| Brazil | Local Institution | Rio de Janeiro | |
| Brazil | Local Institution | Sao Paulo | |
| Canada | Local Institution | Halifax | Nova Scotia |
| Canada | Local Institution | Hamilton | Ontario |
| Canada | Local Institution | Montreal | Quebec |
| Canada | Local Institution | Ottawa | Ontario |
| Canada | Local Institution | Sherbrooke | Quebec |
| Canada | Local Institution | Toronto | Ontario |
| Canada | Local Institution | Toronto | Ontario |
| Chile | Local Institution | Santiago | Metropolitana |
| Chile | Local Institution | Santiago | Metropolitana |
| Colombia | Local Institution | Medellin | |
| Germany | Local Institution | Berlin | |
| Germany | Local Institution | Cologne | |
| Germany | Local Institution | Erlangen | |
| Germany | Local Institution | Essen | |
| Germany | Local Institution | Frankfurt am Main | |
| Germany | Local Institution | Freiburg | |
| Germany | Local Institution | Hamburg | |
| Germany | Local Institution | Hannover | |
| Germany | Local Institution | Jena | |
| Germany | Local Institution | Mainz | |
| Germany | Local Institution | Mannheim | |
| Germany | Local Institution | Marburg | |
| Germany | Local Institution | Paderborn | |
| Germany | Local Institution | Reutlingen | |
| Germany | Local Institution | Wiesbaden | |
| Italy | Local Institution | Bergamo | |
| Italy | Local Institution | Milano | |
| Italy | Local Institution | Napoli | |
| Italy | Local Institution | Reggio Emilia | |
| Mexico | Local Institution | Aguascalientes | |
| Mexico | Local Institution | Merida | Yucatan |
| Mexico | Local Institution | Mexico City | Distrito Federal |
| Mexico | Local Institution | Tuxtla Gutierrez | Chiapas |
| Mexico | Local Institution | ZONA Centro. LEON | Guanajuato |
| Portugal | Local Institution | Lisboa | |
| Portugal | Local Institution | Porto | |
| Puerto Rico | Local Institution | Rio Piedras | |
| Romania | Local Institution | Bucuresti | |
| Romania | Local Institution | Cluj-Napoca | |
| Romania | Local Institution | Craiova | |
| Romania | Local Institution | Floresti | |
| Spain | Local Institution | Badajoz | |
| Spain | Local Institution | Madrid | |
| Spain | Local Institution | Madrid | |
| Spain | Local Institution | Madrid | |
| Spain | Local Institution | Valencia | |
| United States | Local Institution | Allentown | Pennsylvania |
| United States | Local Institution | Aurora | Colorado |
| United States | Local Institution | Bakersfield | California |
| United States | Local Institution | Boston | Massachusetts |
| United States | Local Institution | Chapel Hill | North Carolina |
| United States | Local Institution | Charlotte | North Carolina |
| United States | Local Institution | Daphne | Alabama |
| United States | Local Institution | Fargo | North Dakota |
| United States | Local Institution | Fullerton | California |
| United States | Local Institution | Lakewood | Colorado |
| United States | Local Institution | Los Angeles | California |
| United States | Local Institution | Marietta | Georgia |
| United States | Local Institution | Miami | Florida |
| United States | Local Institution | New Brunswick | New Jersey |
| United States | Local Institution | Redondo Beach | California |
| United States | Local Institution | Saint Louis | Missouri |
| United States | Local Institution | Santa Barbara | California |
| United States | Local Institution | Sioux Falls | South Dakota |
| United States | Local Institution | Tampa | Florida |
| United States | Local Institution | Vancouver | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Argentina, Australia, Brazil, Canada, Chile, Colombia, Germany, Italy, Mexico, Portugal, Puerto Rico, Romania, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall response rate (ORR) | Approximately 31 months | ||
| Secondary | Incidence of adverse events (AEs) | Approximately 5 years | ||
| Secondary | Incidence of serious adverse events (SAEs) | Approximately 5 years | ||
| Secondary | Incidence of AEs leading to discontinuation | Approximately 5 years | ||
| Secondary | Incidence of deaths | Approximately 5 years | ||
| Secondary | Incidence of laboratory abnormalities | Approximately 5 years | ||
| Secondary | ORR | Cohort A1 | Approximately 5 years | |
| Secondary | Duration of response (DOR) | Approximately 5 years | ||
| Secondary | Progression free survival (PFS) | Approximately 5 years | ||
| Secondary | Overall survival (OS) | Approximately 5 years |
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