Study on Reducing Treatment for HPV-Negative Head and Neck Cancer

Inclusion Criteria

• Have a confirmed diagnosis of locally advanced, non-metastatic HPV-negative head and neck cancer in areas like the mouth, throat, or sinuses.
• Be in Stage IV, except for certain nasopharyngeal tumors which can be Stage III.
• If the cancer is in the oropharynx, it must be confirmed as HPV-negative.
• Provide at least 10 unstained slides from a biopsy, or be willing to undergo a new biopsy if needed.
• Be at least 18 years old.
• Have measurable cancer that can be tracked using standard criteria.
• Have not received previous radiation or chemotherapy for head and neck cancer.
• Have not had complete surgical removal of the cancer within 8 weeks before joining the study, except for certain biopsies or surgeries that leave measurable cancer.
• Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have normal organ function as shown by specific blood tests.
• Agree to sign an informed consent form and understand the study.
• Women of childbearing potential must have a negative pregnancy test before starting the study and agree to use effective contraception during and for 6 months after treatment.
• Men must agree to use effective contraception during and for 6 months after treatment if sexually active with women of childbearing potential.

Exclusion Criteria

• Have cancer that has spread to distant parts of the body.
• Have an unknown primary cancer site.
• Have medical conditions that would make it hard to tolerate treatment or affect survival, like active infections or heart problems.
• Have had major surgery for head and neck cancer, except for certain biopsies or surgeries that leave measurable cancer.
• Be taking other experimental drugs.
• Have an immune deficiency or be on high-dose steroids or other immune-suppressing drugs recently.
• Have a history of active tuberculosis.
• Be allergic to nivolumab or any drugs used in the study.
• Have had other cancer treatments in the last 8 weeks.
• Have another active cancer that needs treatment, except for certain skin cancers or in situ cervical cancer.
• Have an active autoimmune disease needing treatment in the past year, except for replacement therapies.
• Have a history of lung inflammation not caused by infection.
• Have HIV.
• Have active hepatitis B or C, unless it has been treated and cleared.
• Have received a live vaccine within 28 days before starting the study.