Study of Zanzalintinib and Pembrolizumab vs Pembrolizumab Alone in Patients with PD-L1 Positive Recurrent or Metastatic Head and Neck Cancer

Inclusion Criteria

• Diagnosed with head and neck squamous cell carcinoma that cannot be cured with local treatments.
• Have not received previous systemic treatment for cancer that has returned or spread, unless it was completed over 6 months ago for locally advanced disease.
• Cancer located in the oropharynx, oral cavity, hypopharynx, or larynx.
• Cancer cells must show a PD-L1 expression level of CPS ≥ 1.
• For oropharyngeal cancer, HPV testing must be done.
• Must have measurable disease as determined by specific medical criteria.
• Provide tumor samples, either from previous tests or a new biopsy.
• Must have recovered from any side effects of previous treatments to a certain level.
• Be 18 years or older.
• Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Have adequate organ and bone marrow function.

Exclusion Criteria

• Cancer located in the nasopharynx, salivary gland, or unknown primary site.
• Cancer that can be treated with local therapy aimed at curing it.
• Have previously received Zanzalintinib or similar drugs targeting PD-1, PD-L1, or PD-L2.
• Life expectancy of less than 3 months.
• Cancer progression within 6 months after completing treatment for locally advanced disease.
• Recent radiation therapy for bone metastases or other areas.
• Untreated or unstable brain metastases.
• Positive tests for hepatitis B or C.
• Recent major surgery without complete healing.
• Heart rhythm issues as indicated by specific ECG results.
• Pregnant or breastfeeding women.
• Recent administration of a live vaccine.