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No longer recruiting (closed or complete)Last updated: 20 September 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18+

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 people with stomach or gastro-oesophageal junction cancers

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

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You have been diagnosed with cancer, but have not received any treatment.

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, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

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No longer recruiting (closed or complete) hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

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

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