An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03662659 |
Recruitment Status :
Active, not recruiting
First Posted : September 7, 2018
Last Update Posted : August 27, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastric Cancer Cancer of the Stomach Esophagogastric Junction | Biological: BMS-986213 Biological: Nivolumab Drug: XELOX Drug: FOLFOX Drug: SOX | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 250 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Open-label, Phase II Clinical Trial of Relatlimab (Anti-LAG-3) and Nivolumab in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy as First-Line Treatment in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma |
Actual Study Start Date : | October 4, 2018 |
Estimated Primary Completion Date : | December 27, 2020 |
Estimated Study Completion Date : | August 15, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: BMS-986213 + investigator's choice chemotherapy
BMS-986213 + XELOX or BMS-986213 + FOLFOX or BMS-986213 + SOX
|
Biological: BMS-986213
Relatlimab + Nivolumab specified dose on specified days Biological: Nivolumab Specified dose on specified days
Other Names:
Drug: XELOX Oxaliplatin + capecitabine Drug: FOLFOX Oxaliplatin + leucovorin + fluorouracil Drug: SOX Oxaliplatin + tegafur/gimeracil/oteracil potassium |
Experimental: Nivolumab + investigator's choice chemotherapy
Nivolumab + XELOX or Nivolumab + FOLFOX or Nivolumab + SOX
|
Biological: Nivolumab
Specified dose on specified days
Other Names:
Drug: XELOX Oxaliplatin + capecitabine Drug: FOLFOX Oxaliplatin + leucovorin + fluorouracil Drug: SOX Oxaliplatin + tegafur/gimeracil/oteracil potassium |
- Objective Response Rate (ORR) [ Time Frame: Up to 22 months ]
- Incidence of Adverse Events (AEs) [ Time Frame: Up to 5 years ]
- Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 5 years ]
- Incidence of AEs leading to discontinuation [ Time Frame: Up to 5 years ]
- Incidence of death [ Time Frame: Up to 5 years ]
- Incidence of laboratory abnormalities [ Time Frame: Up to 5 years ]
- Duration of Response (DOR) [ Time Frame: Up to 5 years ]
- Overall survival (OS) [ Time Frame: Up to 5 years ]
- Progression Free Survival (PFS) [ Time Frame: Up to 5 years ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Histologically- or cytologically-confirmed diagnosis of unresectable and either locally advanced, or metastatic gastric cancer or GEJ adenocarcinoma
- No prior treatment with systemic treatment (including HER 2 inhibitors) given as primary therapy for unresectable and either locally advanced, or metastatic GC or GEJ adenocarcinoma
- Tumor tissue must be provided for biomarker analyses
Exclusion Criteria:
- Participants with HER2 positive status
- Participants with known untreated central nervous system (CNS) metastases
- Uncontrolled or significant cardiovascular disease
Other protocol defined inclusion/exclusion criteria could apply

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662659

Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT03662659 |
Other Study ID Numbers: |
CA224-060 2018-001069-18 ( EudraCT Number ) |
First Posted: | September 7, 2018 Key Record Dates |
Last Update Posted: | August 27, 2020 |
Last Verified: | August 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Stomach Diseases Nivolumab Antineoplastic Agents, Immunological Antineoplastic Agents |