Study #2024-1216
A phase 1/2 open-label, umbrella platform design study of investigational agents with or without Pembrolizumab (MK-3475) and/or chemotherapy in participants with advanced esophageal cancer: Master (KEYMAKER-U06)
MD Anderson Study Status
Enrolling
Treatment Agent
Pembrolizumab, Capecitabine, Leucovorin, Levoleucovorin, 5-FU, Sacituzumab Tirumotecan (sac-TMT)
Description
This is a phase 1/2, multicenter, open-label umbrella platform study that will evaluate the safety and tolerability of sacituzumab tirumotecan with pembrolizumab and fluoropyrimidine chemotherapy for the first-line (1L) treatment of participants with locally 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. The safety lead-in phase will be used to evaluate the safety and tolerability, and to establish a recommended Phase 2 dose (RP2D) for sacituzumab tirumotecan in combination with chemotherapy and immunotherapy. There is no formal hypothesis in this study.
Resources and Links
Phone Number: 1-877-MDA-6789
Information and next steps
Disease:
Gastroesophageal Junction, Gastroesophageal Adenocarcinoma, Esophageal Neoplasms, Esophageal Cancer
Study phase:
Physician name:
Jaffer Ajani
Department:
Gastrointestinal Medical Oncology
For general questions about clinical trials:
1-855-499-2252
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