Phase 2 Study of Pembrolizumab and Trastuzumab Combined with Chemotherapy for Treating Resectable HER2 Esophageal and Gastric Cancer

What this Trial Is About

Researchers are evaluating whether adding the drugs pembrolizumab and trastuzumab to standard chemotherapy improves treatment for adults with resectable HER2-positive esophagogastric cancer. This phase 2 study focuses on patients with esophageal, gastroesophageal junction, or gastric adenocarcinoma that expresses HER2, aiming to assess the effectiveness of this combination therapy before and after surgery. Participants will receive eight peri-operative treatment cycles combining pembrolizumab, trastuzumab, and chemotherapy drugs such as fluoropyrimidine and oxaliplatin initially, then a regimen called FLOT, which includes 5-fluorouracil, oxaliplatin, and docetaxel. After these cycles, maintenance therapy with pembrolizumab and trastuzumab will continue to complete one year of treatment. Pembrolizumab and trastuzumab are administered every three weeks, with chemotherapy given on various schedules including oral and intravenous routes. During the study, participants will undergo regular assessments including optional nutrition questionnaires and sample collections like stool and saliva. Researchers will monitor event-free survival over two years to evaluate how well the treatment prevents cancer recurrence or progression. Safety and organ function will be closely observed, and participants will be followed through treatment and recovery until study completion in 2027.

A Study of Pembrolizumab With Trastuzumab and Chemotherapy in People With Esophagogastric Cancer