Study on New Immunotherapy Combinations for First-Line Treatment in Patients with PD-L1 Positive Recurrent/Metastatic Head and Neck Cancer

Inclusion Criteria

• Have a confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) that has come back or spread and cannot be cured with local treatments.
  • Must not have had previous systemic therapy for recurrent/metastatic cancer. Previous chemoradiation is allowed if completed more than 4 months ago.
  • Eligible tumor locations include the oropharynx, oral cavity, hypopharynx, and larynx. Tumors in the nasopharynx are not eligible.
• Have measurable disease as determined by the study doctor.
• Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Provide a tumor tissue sample from the time of or after the initial diagnosis of recurrent/metastatic HNSCC. A recent sample within 90 days is preferred, but an older sample up to 2 years old is acceptable if a new biopsy is not possible.
• Tumor must show PD-L1 expression.
• If the primary tumor is in the oropharynx, HPV test results are required.

Exclusion Criteria

• Have received previous treatment with immune checkpoint inhibitors targeting PD-1, PD-L1, CTLA-4, TIGIT, CD96, or similar pathways.
• Have had another cancer (except certain skin and in situ cancers) unless in complete remission for at least 2 years and no further treatment is needed during the study.
• Have active tumor bleeding or a high risk of bleeding, such as major blood vessel involvement.
• Have disease progression within 4 months of completing treatment for locally advanced HNSCC.
• Have cancer spread to the brain or spinal cord that is not controlled or causing symptoms.
• Have an active autoimmune disease requiring treatment in the past 2 years, except for stable, managed autoimmune endocrine disorders.