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Closed (no longer recruiting)Last updated: 30 January 2024

FRACTION-GC: This Phase II trial is trying to determine the most effective combination therapy for the immunotherapy drug Nivolumab in patients with advanced gastric cancerA Phase 2, Fast Real-time Assessment of Combination Therapies in Immuno-ONcology Study in Participants With Advanced Gastric Cancer

Clinical summary

Summary

The purpose of this study is to determine whether Nivolumab in combination with other therapies is more effective than Nivolumab in combination with Ipilimumab in treating patients/subjects with advanced gastric cancer.

Conditions

This trial is treating patients with gastric (stomach) cancer.

Cancer

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18 - 110

Phase

II

Trial Acronym

FRACTION-GC

More information

Trial Identifiers

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Trial sponsor

Bristol-Myers Squibb (BMS)

Scientific Title

A Phase 2, Fast Real-time Assessment of Combination Therapies in Immuno-ONcology Study in Participants With Advanced Gastric Cancer

Eligibility

Inclusion

  • Inoperable, advanced or metastatic esophageal cancer (EC), gastric cancer (GC) or gastroesophageal junction (GEJ) carcinoma and have histologically confirmed predominant adenocarcinoma and/or squamous carcinoma
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  • At least 1 lesion with measurable disease

Exclusion

  • HER2-positive tumor and previously untreated with trastuzumab
  • Suspected, known or progressive central nervous system metastases
  • Other active malignancy requiring concurrent intervention
  • Active, known or suspected autoimmune disease

Other protocol-defined inclusion/exclusion criteria apply

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

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