Pembrolizumab + Chemotherapy for Stomach Cancer
Trial Summary
What is the purpose of this trial?
The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma. The primary study hypotheses are that: * Neoadjuvant and adjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab is superior to neoadjuvant and adjuvant placebo plus chemotherapy, followed by adjuvant placebo in terms of Event-free Survival (EFS) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), and * Neoadjuvant pembrolizumab plus chemotherapy is superior to neoadjuvant placebo plus chemotherapy in terms of rate of Pathological Complete Response (pathCR) at the time of surgery. With Amendment 10, upon study completion, participants will be discontinued and may be enrolled in an extension study.
Eligibility Criteria
Adults with untreated gastric or GEJ adenocarcinoma, planning surgery after chemotherapy, able to provide tissue samples, and in good physical condition (ECOG score 0-1). Must have a life expectancy over 6 months and adequate organ function. Women must use contraception for 180 days post-chemo or 120 days post-pembrolizumab; men also need to agree to contraception.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- 5-fluorouracil (Chemotherapy)
- Capecitabine (Chemotherapy)
- Cisplatin (Chemotherapy)
- Docetaxel (Chemotherapy)
- Leucovorin (Chemotherapy)
- Oxaliplatin (Chemotherapy)
- Pembrolizumab (Monoclonal Antibodies)
5-fluorouracil is already approved in United States, European Union, Canada, Japan for the following indications:
- Colorectal cancer
- Breast cancer
- Stomach cancer
- Pancreatic cancer
- Esophageal cancer
- Anal cancer
- Colorectal cancer
- Breast cancer
- Stomach cancer
- Pancreatic cancer
- Esophageal cancer
- Anal cancer
- Colorectal cancer
- Breast cancer
- Stomach cancer
- Pancreatic cancer
- Esophageal cancer
- Anal cancer
- Colorectal cancer
- Breast cancer
- Stomach cancer
- Pancreatic cancer
- Esophageal cancer
- Anal cancer