drugset / Trial / NCT05508737

Pembrolizumab and Trifluridine/Tipiracil With Previously Treated Advanced Gastric Cancer

NCT05508737 ↗

Phase 1/2 Active not recruiting 75 enrolled Yonsei University
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a two-part, Phase II, open-label, single arm, multi-center study to determine the efficacy of pembrolizumab in combination with TAS-102 (trifluridine/tipiracil) in patients with advanced gastric cancer who have progressed after prior treatment with or without anti-PD-1/PD-L1 agent, and to further assess the safety and tolerability of this combination treatment.

Timeline

Start
2022-12-01
Primary completion
2025-11-02
Completion
2025-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody 400 mg Intravenous
Subject Trifluridine/Tipiracil Unknown 30 mg/m2 —
Subject Trifluridine/Tipiracil Unknown 35 mg/m2 —