Phase 12 Study of Investigational Drugs With or Without Pembrolizumab and Chemotherapy in Adults With Advanced Esophageal Squamous Cell Carcinoma Previously Treated With PD-1PD-L1 Therapy

What this Trial Is About

Researchers are conducting a Phase 12, multicenter, randomized, open-label study to assess the safety and effectiveness of investigational agents used with or without pembrolizumab andor chemotherapy in participants with advanced esophageal squamous cell carcinoma ESCC who have previously received PD-1PD-L1 based treatment. This study aims to explore new treatment options for individuals whose cancer has progressed after initial immune therapy. Participants will be assigned to different treatment groups. Some will receive paclitaxel or irinotecan chemotherapy on specific schedules until disease progression or discontinuation. Others will receive combinations including pembrolizumab with MK-4830 plus paclitaxel, irinotecan, or lenvatinib. Additional groups will receive sacituzumab tirumotecan at varying doses on a 42-day cycle. Supportive medications may be given to manage side effects as needed. During the study, participants will undergo evaluations to monitor safety, including tracking dose-limiting toxicities and adverse events during an initial safety phase of about 3 weeks. Effectiveness will be assessed over up to 48 months by measuring tumor response and longer-term outcomes such as progression-free survival, duration of response, and overall survival up to approximately 70 months. Participants will have regular visits for treatment and monitoring throughout their involvement, which may last several years.

A Study to Evaluate Investigational Agents With or Without Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer Previously Exposed to Programmed Cell Death 1 Protein (PD-1)/ Programmed Cell Death Ligand 1 (PD-L1) Treatment (MK-3475-06B)