Study on the Effectiveness and Safety of Pembrolizumab, Lenvatinib, and Chemotherapy for Metastatic Esophageal Cancer

Inclusion Criteria

• Diagnosed with metastatic squamous cell carcinoma of the esophagus.
• Male participants must agree to use contraception or abstain from sex during the study and for a specified time after the last dose of medication.
• Female participants must not be pregnant or breastfeeding and must use effective contraception or abstain from sex during the study and for a specified time after the last dose of medication.
• Blood pressure must be controlled, with or without medication.
• Must have adequate organ function.

Exclusion Criteria

• Have had previous treatment for advanced or metastatic esophageal cancer.
• Have locally advanced esophageal cancer or metastatic adenocarcinoma of the esophagus.
• Have cancer that has spread to nearby organs or major blood vessels.
• Have risks of gastrointestinal bleeding or perforation.
• Have had significant bleeding or tumor bleeding recently.
• Have uncontrolled fluid buildup around the lungs, heart, or abdomen.
• Have gastrointestinal obstruction or difficulty taking oral medication.
• Have had major surgery or significant injury recently.
• Have received recent radiotherapy or have a history of radiation lung disease.
• Have received a live vaccine recently.
• Have an immune deficiency or are on immunosuppressive therapy.
• Have another progressing cancer or have had active treatment for another cancer recently.
• Have active brain metastases or cancer in the brain lining.
• Have an active autoimmune disease requiring treatment.
• Have a history of lung disease requiring steroids.
• Have poorly controlled diarrhea.
• Have significant heart disease recently.
• Have severe nerve damage.
• Have a history of HIV, Hepatitis B, or active Hepatitis C.
• Have lost more than 20% of body weight recently.