Study on Ramucirumab and Pembrolizumab for Patients with Recurrent or Metastatic Head and Neck Cancer

Inclusion Criteria

• Have head and neck cancer that cannot be cured with surgery or radiation, or have chosen not to undergo curative treatment.
• For Phase I: Cancer can be in the oral cavity, oropharynx, larynx, hypopharynx, nasopharynx, paranasal sinus, or salivary gland.
• For Phase II: Cancer can be in the oral cavity, oropharynx, larynx, or hypopharynx.
• Cancer must be measurable by medical standards.
• For Phase I: Any number of previous treatments for recurrent/metastatic cancer is allowed.
• For Phase II: No prior systemic therapy for recurrent/metastatic cancer.
• Be at least 18 years old.
• Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
• Have adequate blood and organ function as determined by specific medical tests.
• Agree to use effective birth control during the study and for a period after the last dose of ramucirumab.
• Provide written informed consent to participate in the study.

Exclusion Criteria

• For Phase II: Have previously received a PD-1 inhibitor for incurable head and neck cancer.
• Have received radiation, chemotherapy, or other treatments within 14 days before starting the study.
• Have had major surgery or a non-healing ulcer within 14 days before starting the study.
• Have had significant bleeding from a tumor site within 14 days before consenting to the study.
• Have had another cancer within the past year, except for certain skin cancers or other low-risk cancers.
• Have severe liver disease or cirrhosis with complications.
• Be taking other investigational drugs.
• Have ongoing severe side effects from previous cancer treatments, except for hair loss, anemia, fatigue, or rash.
• Have active cancer spread to the brain that is currently being treated with radiation.
• Have a history of severe allergic reactions to study drugs.
• Have serious uncontrolled illnesses or psychiatric conditions that could interfere with the study.
• Be taking high doses of steroids or other immunosuppressive drugs within 7 days before starting pembrolizumab.
• Have an active autoimmune disease requiring recent treatment.
• Have had gastrointestinal perforation or fistula within 6 months before starting the study.
• Have gastrointestinal issues like inflammatory bowel disease.
• Have poorly controlled high blood pressure.
• Have had recent serious heart or blood vessel problems.
• Have had significant gastrointestinal bleeding within 3 months before starting the study.
• Be pregnant or breastfeeding, and must have a negative pregnancy test before starting the study.