Study on Pembrolizumab and Cetuximab for Treating Recurrent or Metastatic Head and Neck Cancer

Inclusion Criteria

• Must understand and agree to sign a consent form.
• Have a confirmed diagnosis of squamous cell carcinoma in the head and neck area that cannot be cured with standard treatments.
• Have cancer that did not respond to platinum-based therapy or are not suitable for it.
• Have at least one tumor that can be measured by scans.
• Be 18 years or older.
• Be in good general health with a performance status of 0 or 1.
• Have adequate blood, liver, and kidney function.
• Women of childbearing potential must have a negative pregnancy test and agree to use two forms of birth control or abstain from sex during the study and for 120 days after the last dose.
• Men with partners of childbearing potential must agree to use contraception during the study and for 120 days after the last dose.

Additional Criteria for Specific Groups:

• For Groups 1 and 2: Must not have received cetuximab in the recurrent/metastatic setting.
• For Groups 2 and 3: Must have shown disease progression after previous PD-1/PD-L1 therapy.
• For Group 4: Must have skin-related HNSCC that cannot be treated with local therapies like surgery or radiation.

Exclusion Criteria

• Have cancer originating from the salivary glands.
• Have received another experimental treatment within 4 weeks before starting the study.
• Have had chemotherapy or radiotherapy within 4 weeks before starting the study, except for certain palliative treatments.
• Have had a major surgery or not fully recovered from surgery within 14 days before starting the study.
• Have had severe side effects from previous immunotherapy.
• Have a history of severe allergic reactions to cetuximab.
• Have another active cancer that requires treatment, except for certain skin cancers or in situ cervical cancer.
• Have active brain metastases or cancer in the brain lining.
• Have an active autoimmune disease requiring treatment in the past 2 years.
• Have a diagnosis of immunodeficiency or are on high-dose steroids or other immunosuppressive therapy.
• Have a history of active tuberculosis.
• Have a history of lung diseases like pneumonitis.
• Have an active infection requiring treatment.
• Have any condition that might interfere with the study or is not in the patient's best interest.
• Have psychiatric or substance abuse disorders that would interfere with the study.
• Are pregnant or breastfeeding, or planning to conceive or father children during the study.
• Have active hepatitis B, hepatitis C, or HIV infection.
• Have received a live vaccine within 30 days before starting the study.

Additional Exclusion for Groups 1 and 4:

• Have received prior immunotherapy with PD-1 or PD-L1 inhibitors.