drugset / Trial / NCT02918162

Perioperative Chemo and Pembrolizumab in Gastric Cancer

NCT02918162 ↗

Phase 2 Completed 49 enrolled Gulam Manji Merck Sharp & Dohme LLC · collab
NaSingle-groupOpen-labelTreatment

Summary

This is a non-randomized, multi-site, open-label trial of pembrolizumab and chemotherapy in subjects with gastric or gastroesophageal (GE) junction adenocarcinoma. The purpose of this study is to determine and evaluate the efficacy of combination therapy with immune checkpoint blockade and chemotherapy used in the perioperative period in eradicating micrometastatic disease; and to compare paired tissue and serum samples (pre-treatment and post-treatment) from individually treated patients to explore the immune effects of combination therapy and predictors of response.

Timeline

Start
2017-11-25
Primary completion
2023-02-28
Completion
2023-02-28

Outcome

Met primary endpoint

paper This trial met its primary end point PMID 37856106 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Epirubicin Small molecule 50 mg/m2 —
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Background Capecitabine Small molecule 625 mg/m2 Oral
Background Oxaliplatin Small molecule 130 mg/m2 Intravenous