Study Comparing Ramucirumab and Pembrolizumab Combination to Pembrolizumab Alone in PD-L1 Positive Head and Neck Cancer

Inclusion Criteria

• Have head and neck cancer that cannot be cured with surgery or radiation, or have declined or are ineligible for such treatments. Eligible cancer sites include the mouth, throat, voice box, and lower throat.
• Cancer must be PD-L1 positive, as determined by a specific test.
• Have measurable cancer according to standard criteria.
• Have not received prior systemic therapy for this type of cancer, unless it developed within 6 months of completing certain treatments.
• Be at least 18 years old.
• Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have normal bone marrow and organ function based on specific blood tests.
• Agree to use effective contraception during the study and for a period after the study, if of childbearing potential.
• Be able to understand and willing to sign a consent form to participate in the study.

Exclusion Criteria

• Have PD-L1 negative cancer.
• Have skin or nasopharynx cancer.
• Have had major surgery recently or plan to have major surgery during the study.
• Have had recent radiation therapy for symptom relief.
• Have serious or non-healing wounds or fractures.
• Have had another cancer within the past year, except for certain skin cancers or other low-risk cancers.
• Have significant liver disease or cirrhosis.
• Are currently taking other experimental drugs.
• Have ongoing side effects from previous cancer treatments, except for certain mild conditions.
• Have active cancer spread to the brain that is currently being treated.
• Have severe allergies to similar drugs used in the study.
• Have serious uncontrolled illnesses or psychiatric conditions.
• Are taking high doses of steroids or other strong immune-suppressing drugs.
• Have active autoimmune diseases requiring recent treatment.
• Have had recent gastrointestinal perforation or fistula.
• Have poorly controlled high blood pressure.
• Have had recent serious blood clots or bleeding issues.
• Are taking certain blood-thinning medications.
• Are pregnant or breastfeeding.