An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Esophagogastric Junction; Gastric Cancer; Cancer of the Stomach

Treatments: Drug: SOX; Drug: XELOX; Biological: BMS-986213; Drug: FOLFOX; Biological: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03662659

2018-001069-18 (EudraCT Number)

CA224-060

Details and patient eligibility

About

The purpose of this study is to determine the efficacy and safety of investigational drug relatlimab plus nivolumab in combination with chemotherapy in participants with unresectable, untreated, locally advanced or metastatic gastric or GEJ cancer.

Enrollment: 274 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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274 participants in 2 patient groups

BMS-986213 + investigator's choice chemotherapy

Experimental group

Description:

BMS-986213 + XELOX or BMS-986213 + FOLFOX or BMS-986213 + SOX

Treatment:

Biological: Nivolumab

Drug: FOLFOX

Biological: BMS-986213

Drug: XELOX

Drug: SOX

Nivolumab + investigator's choice chemotherapy

Experimental group

Description:

Nivolumab + XELOX or Nivolumab + FOLFOX or Nivolumab + SOX

Treatment:

Biological: Nivolumab

Drug: FOLFOX

Drug: XELOX

Drug: SOX