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FRACTION-GC: Nivolumab Combinations in Advanced Gastric Cancer
NCT02935634Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2016
- Primary completion
- May 2022
- Countries
- 9
- Sponsor
- Bristol Myers Squibb
- Modality
- Small Molecules, Immune Checkpoint Inhibitors
- Conditions
- gastric cancer (GC)esophageal cancergastroesophageal junction cancer
01
Overview
Phase 2, randomised, open-label trial of relatlimab, linrodostat and rucaparib in gastric cancer (GC), esophageal cancer and gastroesophageal junction cancer (6 arms), sponsored by Bristol Myers Squibb. Primary endpoints: Objective Response Rate up to 65 months, Duration of Response up to 65 months and 1 more. Started Nov 2016; status: completed.
02
Design
6 arms- Study design
- RandomizedOpen-label
Nivo + Ipi
Nivolumab + Ipilimumab
Nivo + Relatlimab
Nivolumab + Relatlimab
Nivo + Linrodostat
Nivolumab + BMS-986205
Nivo + Rubraca
Nivolumab + Rucaparib
Ipi + Rubraca
Ipilimumab + Rucaparib
Nivo + Ipi + Rubraca
Nivolumab + Ipilimumab + Rucaparib
03
Who it enrols
Patients with inoperable, advanced or metastatic gastric, esophageal, or GEJ cancer with ECOG 0-1 and measurable disease. Excludes HER2+ untreated with trastuzumab, active CNS metastases, and active autoimmune disease.
04
Endpoints
Primary
Objective Response Rate
Duration of Response
Progression Free Survival Rate
Secondary
Adverse Events
Laboratory Abnormalities in Specific Thyroid Tests
Laboratory Abnormalities in Specific Liver Tests
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