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No longer recruiting (closed or complete)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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18 - 110

Trial acronym

FRACTION-GC

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 people with gastric (stomach) 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 (metastatic) or has grown into nearby parts of the body (locally advanced).

Exclusion

  • You have certain types of non-cancer medical conditions.
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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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 Phase 2, Fast Real-time Assessment of Combination Therapies in Immuno-ONcology Study in Participants With Advanced Gastric Cancer

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