Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014)

Exclusion Criteria

• •Has had previous therapy for locally advanced unresectable or metastatic esophageal cancer
• •Has locally advanced esophageal carcinoma
• •Has metastatic adenocarcinoma of the esophagus
• •Has direct invasion into adjacent organs such as the aorta or trachea
• •Has radiographic evidence of encasement of a major blood vessel, or of intratumoral cavitation
• •Has perforation risks or significant gastrointestinal (GI) bleeding
• •Has had clinically significant hemoptysis within 3 weeks prior to the first dose of study drug or tumor bleeding within 2 weeks prior to the first dose of study intervention
• •Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention
• •Has GI obstruction, poor oral intake, difficulty in taking oral medication, or existing esophageal stent
• •Has had major surgery, open biopsy, or significant traumatic injury within 3 weeks prior to first dose of study interventions
• •Has received prior radiotherapy within 2 weeks of start of study intervention or have had a history of radiation pneumonitis
• •Has received a live or live attenuated vaccine within 30 days prior to the first dose of study intervention; administration of killed vaccines is allowed
• •Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any form of immunosuppressive therapy within 7 days prior to the first dose of study intervention, or has a history of organ transplant, including allogeneic stem cell transplant
• •Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
• •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
• •Has an active autoimmune disease that has required systemic treatment in past 2 years; replacement therapy is not considered a form of systemic treatment and is allowed
• •Has a history of non-infectious pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease
• •Has poorly controlled diarrhea
• •Has clinically significant cardiovascular disease within 12 months from first dose of study intervention
• •Has peripheral neuropathy ≥Grade 2
• •Has a known history of human immunodeficiency virus (HIV) infection
• •Has a known history of Hepatitis B or know active Hepatitis C virus infection
• •Has a weight loss of \>20% within the last 3 months