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ACTIVE NOT RECRUITING
NCT05508737
PHASE1/PHASE2

Pembrolizumab and Trifluridine/Tipiracil With Previously Treated Advanced Gastric Cancer

Sponsor: Yonsei University

View on ClinicalTrials.gov

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.

Official title: Open-label Phase II Study With Lead-in Safety Cohort of Pembrolizumab (Keytruda®) and Trifluridine/Tipiracil (Lonsurf®) Combination Treatment in Patients With Previously Treated Advanced Gastric Cancer

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2022-12-01

Completion Date

2025-12-01

Last Updated

2025-07-11

Healthy Volunteers

No

Interventions

DRUG

Pembrolizumab (Keytruda®), Trifluridine/Tipiracil (Lonsurf®)

arms : Pembrolizumab 400 mg every 6 weeks (Q6W), trifluridine/tipiracil at 35 or 30 mg/m2 twice daily (BID) for 5 days a week (D1-5, D8-12) with 2 days rest for 2 weeks, followed by a 14-day rest, repeated every 4 weeks (Q4W)

Locations (2)

Severance Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea