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)

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.

Trial Details

NCT ID

NCT05319730

Phase

PHASE1 / PHASE2

Sponsor

Merck Sharp & Dohme LLC

Status

RECRUITING

Cancer Type

Esophageal Cancer

Interventions

Paclitaxel
Irinotecan
Pembrolizumab
MK-4830
Lenvatinib
Sacituzumab tirumotecan

Locations (sample)

Tucson, Arizona, United States|32.22174,-110.92648
Los Angeles, California, United States|34.05223,-118.24368
East Syracuse, New York, United States|43.06534,-76.07853
New York, New York, United States|40.71427,-74.00597
Pittsburgh, Pennsylvania, United States|40.44062,-79.99589

Key Eligibility Criteria

Inclusion Criteria:
Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable esophageal squamous cell carcinoma (ESCC)
Has experienced investigator documented radiographic or clinical disease progression on one prior line of standard therapy, that includes a platinu…
Has provided an archival or most recent tumor tissue sample obtained as part of clinical practice

For full eligibility, visit ClinicalTrials.gov.

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