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Pembrolizumab and Trifluridine/Tipiracil With Previously Treated Advanced Gastric Cancer

NCT05508737 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-07-11

No results posted yet for this study

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.

Conditions

  • Gastric and Gastroesophageal Junction Adenocarcinoma

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)

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • SUN YOUNG Rha · Yonsei Cancer Center, Yonsei University College of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05508737 on ClinicalTrials.gov