MK-3475-06C KEYMAKER

Gastrointestinal tumors
Esophageal and Gastric Cancer
First-Line-Therapy (Metastatic Disease/Hematology)
This is a phase 1/2, multicenter, open-label umbrella platform study that will evaluatethe safety and tolerability of sacituzumab tirumotecan with pembrolizumab andfluoropyrimidine chemotherapy for the first-line (1L) treatment of participants withlocally advanced unresectable or metastatic human epidermal growth factor receptor 2(HER2)-negative gastric, gastroesophageal junction, or esophageal adenocarcinoma.This substudy will have two phases: a safety lead-in phase and an efficacy phase. Thesafety lead-in phase will be used to evaluate the safety and tolerability, and toestablish a recommended Phase 2 dose (RP2D) for sacituzumab tirumotecan in combinationwith chemotherapy and immunotherapy. There is no formal hypothesis in this study.
This is a phase 1/2, multicenter, open-label umbrella platform study that will evaluatethe safety and tolerability of sacituzumab tirumotecan with pembrolizumab andfluoropyrimidine chemotherapy for the first-line (1L) treatment of participants withlocally advanced unresectable or metastatic human epidermal growth factor receptor 2(HER2)-negative gastric, gastroesophageal junction, or esophageal adenocarcinoma.This substudy will have two phases: a safety lead-in phase and an efficacy phase. Thesafety lead-in phase will be used to evaluate the safety and tolerability, and toestablish a recommended Phase 2 dose (RP2D) for sacituzumab tirumotecan in combinationwith chemotherapy and immunotherapy. There is no formal hypothesis in this study.