Study on Combining Fianlimab and Cemiplimab for Treating Recurrent or Metastatic Head and Neck Cancer

Inclusion Criteria

• Have a confirmed diagnosis of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that cannot be cured with local treatments.
• The primary tumor must be located in the oral cavity, oropharynx, larynx, or hypopharynx.
• Must have a PD-L1 expression score of 1 or higher from a previous test.
• For oropharynx cancer patients, HPV status must be confirmed from a biopsy.
• Have at least one tumor that can be measured by standard criteria.
• Be in good overall health with an ECOG performance status of 0 or 1.
• Have adequate organ and bone marrow function.

Exclusion Criteria

• Have had cancer progression within 6 months after completing treatment for advanced head and neck cancer.
• Have a primary tumor in the nasopharynx, paranasal sinus, or salivary gland.
• Have head and neck cancer with an unknown primary site.
• Have an active or suspected autoimmune disease requiring treatment in the past 5 years.
• Have a history of lung diseases like pulmonary fibrosis or pneumonia requiring steroids.
• Have significant heart disease, such as heart failure, unstable chest pain, or recent heart attack.
• Have received previous systemic cancer treatment for recurrent or metastatic head and neck cancer.
• Require corticosteroid therapy above a certain dose within 14 days before starting the study treatment.