drugset
drugset / Trial / NCT05319730

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)

NCT05319730 ↗

Phase 1/2 Recruiting 230 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase 1/2, multicenter, randomized, open-label umbrella platform study to evaluate the safety and efficacy of investigational agents with or without pembrolizumab and/or chemotherapy, for the treatment of participants with second line (2L) esophageal squamous cell carcinoma (ESCC) who have previously been exposed to PD-1/PD-L1 based treatment.

Timeline

Start
2023-05-16
Primary completion
2027-06-11
Completion
2029-04-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 180 mg/m2 Intravenous
Subject Lenvatinib Small molecule 20 mg Oral
Subject MK-4830 Unknown 800 mg Intravenous
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous
Subject Paclitaxel Small molecule 100 mg/m2 Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject Sacituzumab Tirumotecan Other / unclassified 4 mg/kg Intravenous
Subject Sacituzumab Tirumotecan Other / unclassified 5 mg/kg Intravenous
Background Acetaminophen Small molecule — —
Background Dexamethasone Small molecule — —

Indications

esophageal squamous cell carcinoma