Study on the Safety and Effects of BNT113 with Pembrolizumab Compared to Pembrolizumab Alone for Head and Neck Cancer with HPV16 and PD-L1 Protein

Inclusion Criteria

• Must sign a consent form before any trial procedures.
• Aged 18 years or older.
• Willing and able to attend scheduled visits and follow the treatment plan.
• Have head and neck cancer that is HPV16 positive and cannot be cured by local treatments.
• Tumor must express PD-L1 protein with a score of 1 or higher.
• Cancer must be located in the oropharynx, oral cavity, hypopharynx, or larynx.
• No prior systemic cancer treatment for incurable recurrent or metastatic cancer.
• Have measurable disease based on specific criteria.
• Good overall health with a performance status of 0 or 1.
• Adequate bone marrow, liver, and kidney function.
• Provide a tumor tissue sample before starting treatment.
• Women of childbearing potential must not be pregnant and must use effective contraception during and after treatment.

Exclusion Criteria

• Pregnant or breastfeeding women.
• Cancer located in the nasopharynx.
• Uncontrolled illnesses, such as infections or heart conditions.
• Recent history of blood clots or lung issues.
• Uncontrolled high blood pressure.
• Known immune system deficiencies or autoimmune diseases.
• Previous organ or stem cell transplants.
• Allergies to study drugs.
• Recent major surgery or planned surgery during the trial.
• Positive tests for HIV, hepatitis B, or hepatitis C.
• Other cancers not in remission for at least 2 years.
• Recent use of certain medications or treatments that affect the immune system.
• Current evidence of significant side effects from previous treatments.
• Brain or spinal metastases that are not stable.
• Substance abuse or other conditions that may interfere with participation.
• Affiliation with the trial site or sponsor.
• Cancer suitable for local curative treatment.
• Life expectancy of less than 3 months or rapidly progressing disease.
• High burden of disease in critical areas.