Study on Xevinapant with Cisplatin and Radiation Therapy After Surgery for Head and Neck Cancer

Inclusion Criteria

• Must be 18 years or older.
• Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Able to swallow liquids or have a functioning feeding tube.
• Diagnosed with squamous cell carcinoma of the head and neck (excluding lip), including specific areas like the maxillary sinus, oral cavity, HPV-negative oropharynx, larynx, and hypopharynx.
• Must have had surgery to remove the cancer within 10 weeks before joining the study, with treatment starting ideally within 6 weeks after surgery.
• Meet specific criteria related to the cancer's characteristics, such as close surgical margins or extranodal extension.
• Have adequate blood cell counts and organ function, including:
  • Neutrophil count of at least 1500 cells/μL.
  • Platelet count of at least 100,000 cells/μL.
  • Hemoglobin level of at least 9.0 g/dL.
  • Liver enzymes and bilirubin levels within specified limits.
• Have adequate kidney function as determined by specific tests.
• Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after treatment.
• Men must agree to use condoms and spermicide during and after treatment, and refrain from donating sperm.

Exclusion Criteria

• Have cancer that has spread to other parts of the body.
• Have had previous radiation treatment for head and neck cancer.
• Have significant nerve damage or hearing loss.
• Have ongoing infections or wound issues.
• Be taking certain prohibited medications.
• Have a history of HIV, active hepatitis B or C, or other serious infections.
• Have received live vaccines recently.
• Have lost more than 10% of body weight recently or have low blood protein levels.
• Have uncontrolled inflammatory diseases or require certain medications.
• Have allergies to Xevinapant or its ingredients.
• Have severe liver disease or other serious health conditions.
• Have had another cancer within the last 3 years, except for certain skin or early-stage cancers.
• Have any condition or behavior that would make participation difficult or unsafe.
• Be unable to understand or agree to the study requirements.