Study on INBRX-106 and Pembrolizumab for First-line Treatment of Advanced Head and Neck Cancer with High PD-L1 Levels

Inclusion Criteria

• Diagnosed with advanced or metastatic head and neck squamous cell carcinoma that cannot be cured with local treatments.
• Cancer must show high levels of PD-L1 (CPS ≥20) based on a lab test.
• Must have results from HPV testing for oropharyngeal cancer.
• Have measurable cancer according to specific medical guidelines.
• Primary cancer location must be in the oral cavity, oropharynx, hypopharynx, or larynx.
• Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Women of childbearing potential must have a negative pregnancy test before starting the study and must not be breastfeeding.
• Men and women of childbearing potential must agree to use effective contraception or abstain from sex during the study.

Exclusion Criteria

• Cancer located in the nasopharynx, salivary glands, or an unknown primary site.
• Have received previous systemic therapy for advanced head and neck cancer, unless it was completed over 6 months ago as part of a treatment plan aimed at curing the disease, and the cancer did not return within 6 months.
• Have active cancer spread to the brain or spinal cord.
• Have an immune system deficiency or are taking medications that suppress the immune system within 7 days before starting the study treatment.
• Have rapidly progressing cancer or cancer that poses a high risk of bleeding or severe pain.
• Have a history of immune-related diseases that required treatment in the past 2 years, except for hormone replacement therapy.