Various Advanced Cancer Clinical Trial
— CheckMate 648Official title:
A Two-Cohort, Open-label, Randomized Phase 2 Study of Nivolumab Monotherapy and in Combination With Ipilimumab in Subjects With Advanced or Metastatic, Previously Treated Gastric Gastroesophageal Junction, or Previously Untreated Esophageal Cancer
The main purpose of this study for patients with gastric or gastroesophageal cancer is to
evaluate how well the tumor is responding to treatment with nivolumab by itself, or in
combination with ipilimumab.
For patients with esophageal cancer, the main purpose is to evaluate how well the tumor is
responding to treatment with the combination of nivolumab and ipilimumab.
| Status | Not yet recruiting |
| Enrollment | 939 |
| Est. completion date | June 1, 2021 |
| Est. primary completion date | May 31, 2020 |
| 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: - Must have gastric, esophageal or gastroesophageal junction cancer that cannot be operated on, that is advanced or has spread out Exclusion Criteria - Presence of tumor cells in the brain or spinal cord that have not been treated - Active known or suspected autoimmune disease Other protocol defined inclusion/exclusion criteria could apply |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Local Institution | Buenos Aires | |
| Argentina | Local Institution | Capital Federal | Buenos Aires |
| Argentina | Local Institution | Cordoba | |
| Argentina | Local Institution | Cordoba | |
| Argentina | Local Institution | La Rioja | |
| Argentina | Local Institution | Rosario | Santa Fe |
| Australia | Local Institution | Blacktown | New South Wales |
| Australia | Local Institution | Clayton | Victoria |
| Australia | Local Institution | North Ballarat | Victoria |
| Australia | Local Institution | Perth | Western Australia |
| Brazil | Local Institution | Barretos | Sao Paulo |
| Brazil | Local Institution | Ijui | Rio Grande do Sul |
| Brazil | Local Institution | Porto Alegre | Rio Grande Do Sul |
| Brazil | Local Institution | Salvador | Bahia |
| Brazil | Local Institution | Sao Jose Do Rio Preto | Sao Paulo |
| Brazil | Local Institution | Sao Paulo | |
| Chile | Local Institution | Independencia | Santiago |
| Chile | Local Institution | Santiago | Metropolitana |
| Colombia | Local Institution | Bogota | |
| Colombia | Local Institution | Medellin | |
| Colombia | Local Institution | Pereira | |
| Czechia | Local Institution | Brno | |
| Czechia | Local Institution | Brno | |
| Czechia | Local Institution | Novy Jicin | |
| Italy | Local Institution | Bergamo | |
| Italy | Local Institution | Milano | |
| Italy | Local Institution | Padova | |
| Japan | Local Institution | Chiba-shi | Chiba |
| Japan | Local Institution | Hiroshima-Shi | Hiroshima |
| Japan | Local Institution | Osaka Sayama-shi | Osaka |
| Peru | Local Institution | Callao | |
| Peru | Local Institution | Lima | |
| Peru | Local Institution | Lima | |
| Peru | Local Institution | Lima | |
| Peru | Local Institution | Lima | |
| Poland | Local Institution | Lublin | |
| Poland | Local Institution | Warszawa | |
| Romania | Local Institution | Bucuresti | |
| Romania | Local Institution | Cluj-Napoca | |
| Romania | Local Institution | Craiova | |
| Romania | Local Institution | Suceava | |
| Russian Federation | Local Institution | Moscow | |
| Russian Federation | Local Institution | St. Petersburg | |
| United Kingdom | Local Institution | London | Greater London |
| United Kingdom | Local Institution | London | Greater London |
| United Kingdom | Local Institution | Manchester | |
| United Kingdom | Local Institution | Surrey |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb | Ono Pharmaceutical Co. Ltd |
Argentina, Australia, Brazil, Chile, Colombia, Czechia, Italy, Japan, Peru, Poland, Romania, Russian Federation, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Investigator Assessed Objective Response Rate (ORR) of GC (Gastric Cancer) Cohort | gastric or gastroesophageal junction | Up to 22 months | |
| Primary | Investigator Assessed ORR of EC (Esophageal Cancer) Cohort | Esophageal Cancer | Up to 22 months | |
| Secondary | Blinded Independent Radiology Review Committee (BIRC) assessed ORR of Cohort GC | Up to 22 months | ||
| Secondary | BIRC assessed ORR of Cohort EC | Up to 22 months | ||
| Secondary | Progression Free Survival (PFS) of Cohort GC | Survival (PFS) is defined as the time from randomization to the date of the first documented disease progression (PD) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 or death due to any cause. | Up to 22 months | |
| Secondary | PFS of Cohort EC | Progression-Free Survival is defined the same way as for the GC Cohort, except that instead of the date of randomization, the date of first dose of study drug will be used. | Up to 22 months | |
| Secondary | Overall Survival (OS) of Cohort GC | OS is defined as the time between the date of randomization and the date of death. | Up to 22 months | |
| Secondary | OS of Cohort EC | Overall Survival is defined the same way as for the GC Cohort, except that instead of the date of randomization, the date of first dose of study drug will be used. | Up to 22 months |
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