Study on Retifanlimab with INCAGN02385 and INCAGN02390 for First-Line Treatment of PD-L1-Positive Head and Neck Cancer

Inclusion Criteria

• Have a confirmed diagnosis of squamous cell carcinoma of the head and neck that cannot be treated with surgery aimed at curing it.
• The cancer must be located in the oropharynx, oral cavity, hypopharynx, or larynx.
• Must not have received any previous systemic treatment for this type of cancer.
• The tumor must be PD-L1 positive, with a CPS score of 1% or higher.
• For oropharyngeal tumors, HPV p16 status must be documented.
• Must have at least one tumor that can be measured by scans.
• Must provide a tissue sample for biomarker analysis or agree to a new biopsy.
• Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Must agree to use effective contraception to prevent pregnancy.

Exclusion Criteria

• Cancer that has progressed or returned within 6 months after the last systemic treatment for locally advanced cancer.
• Previous treatment with certain immune therapies for any cancer.
• Participation in another clinical study or treatment with anticancer therapies within 21 days before starting this study.
• Tumors that invade major blood vessels and are actively bleeding.
• Primary tumors located in the nasopharynx, sinonasal cavity, or salivary glands.
• Life expectancy of less than 3 months.
• Not fully recovered from side effects of previous treatments or surgeries.
• Recent radiation therapy to the chest or palliative radiation within 1 week before starting the study.
• Active cancer spread to the brain or spinal cord, unless treated more than 4 weeks ago.