A Study to Evaluate 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

• Status: Not yet recruiting
• Trial end date: 2027-03-24
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1/2, multicenter, randomized, open-label umbrella platform study to evaluate the safety and efficacy of investigational agents with pembrolizumab, with or without 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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Immunoglobulins; Irinotecan; Lenvatinib; Paclitaxel; Pembrolizumab

Criteria

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable ESCC.

• Has experienced documented radiographic or clinical disease progression on one prior line of standard therapy, that includes a platinum agent and previous exposure to an anti-PD1/PD-L1 based therapy.

• Has experienced documented radiographic or clinical disease. progression on one prior line of standard therapy.

• Has an evaluable baseline tumor sample (newly obtained or archival) for analysis.

• Has adequately controlled blood pressure (BP) with or without antihypertensive medications.

Exclusion Criteria:

• Direct invasion into adjacent organs such as the aorta or trachea.

• Has experienced weight loss >10% over approximately 2 months prior to first dose of study therapy.

• Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.

• Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication.

• Known additional malignancy that is progressing or has required active treatment within the past 3 years, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that has undergone potentially curative therapy.

• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

• Active autoimmune disease that has required systemic treatment in past 2 years.

• History of human immunodeficiency virus (HIV) infection.

• History of Hepatitis B or known active Hepatitis C virus infection.

• History of allogenic tissue/solid organ transplant.

• Clinically significant cardiovascular disease within 12 months from first dose of study intervention.

• Gastrointestinal (GI) obstruction, poor oral intake, or difficulty in taking oral medication.