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Closed (no longer recruiting)Last updated: 1 February 2024

This phase II trial is assessing two immunotherapy drugs (Relatlimab + Nivolumab) in combination with chemotherapy for the treatment of previously untreated, advanced stomach or gastro-oesophageal junction cancersA Randomized, Open-label, Phase II Clinical Trial of Relatlimab (Anti-LAG-3) Plus Nivolumab in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy as First-Line Treatment in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma

Clinical summary

Summary

In this trial, patients will be randomised into one of two cohorts. In Arm 1 patients will receive BMS-986213 (Relatlimab + Nivolumab) + investigator's choice chemotherapy on specified days. In Arm 2, patients will receive Nivolumab (alone) + investigator's choice chemotherapy on specified days.

Conditions

This trial is treating patients with stomach or gastro-oesophageal junction cancers.

Cancer

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18+

Phase

II

More information

Trial Identifiers

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Trial sponsor

Bristol-Myers Squibb (BMS)

Scientific Title

A Randomized, Open-label, Phase II Clinical Trial of Relatlimab (Anti-LAG-3) Plus Nivolumab in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy as First-Line Treatment in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma

Eligibility

Inclusion

  • 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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Exclusion

  • 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

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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