Trial intelligence / Profile preview

BMS-986213 with standard-of-care regimens in recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma

2018-001070-20Phase 2

Key facts

Status
Terminated
Start
Oct 2018
Countries
1
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Immune Checkpoint Inhibitors → Monoclonal Antibodies → Antibody-Based Therapeutics
Conditions
gastric adenocarcinomagastroesophageal junction adenocarcinoma
01

Overview

Phase 2, randomised, open-label trial of nivolumab + relatlimab, relatlimab and nivolumab in gastric adenocarcinoma and gastroesophageal junction adenocarcinoma (2 cohorts), sponsored by Bristol Myers Squibb. Primary endpoint: Objective response rate. Started Oct 2018; status: terminated.

02

Design

2 arms
Study design
RandomizedOpen-label
  • Cohort A1 experimental

    BMS-986213 fixed-dose combination of relatlimab and nivolumab with ramucirumab and paclitaxel.

  • Cohort A1 active control

    Ramucirumab and paclitaxel standard-of-care active control.

03

Who it enrols

Adults with confirmed recurrent, locally advanced, or metastatic gastric or gastroesophageal junction adenocarcinoma that was not curable with local therapies; squamous cell and undifferentiated histologies were excluded.

04

Endpoints

Primary

  • Objective response rate

Secondary

  • Incidence of nonserious adverse events and serious adverse events leading to discontinuation

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