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

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma focused on measuring Esophageal cancer, Programmed Cell Death 1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL-1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL-2, PD-L2) Read More

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 investigator 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 an evaluable baseline tumor sample (newly obtained or archival) for analysis.
• Has adequately controlled blood pressure (BP) with or without antihypertensive medications.
• Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible.

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.
• Has risk for significant GI bleeding, such as:
• Has had a serious nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to allocation/randomization.
• Has significant bleeding disorders, vasculitis, or has had a significant bleeding episode from the GI tract within 12 weeks prior to allocation/randomization.