Study on Response-Adaptive Treatment for Untreated HPV-Negative Head and Neck Cancer

Inclusion Criteria

• Must have a confirmed diagnosis of locally advanced head and neck cancer in areas like the mouth, throat, or sinuses, and it must be HPV-negative.
• Must be able to give informed consent and agree to follow the study requirements, including attending all scheduled visits and treatments.
• Must have Stage IV disease, except for certain cases of nasopharyngeal cancer.
• Must have at least one tumor that can be measured by scans or exams.
• Must not have received any previous treatment like radiation, chemotherapy, or immunotherapy for head and neck cancer.
• Must be 18 years or older.
• Must be in good general health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Must have adequate blood counts and organ function as determined by specific medical tests.
• Must not have had major surgery for head and neck cancer within 8 weeks before joining the study.
• Women and men must agree to use effective birth control during the study and for a period after the study to prevent pregnancy.

Exclusion Criteria

• Cancer that has spread to distant parts of the body.
• Unknown primary site of cancer.
• Previous major surgery for head and neck cancer, except for certain minor procedures.
• Currently receiving other experimental treatments.
• Have another active cancer, except for certain non-threatening types.
• History of severe allergic reactions to similar drugs used in the study.
• Uncontrolled medical conditions that could interfere with the study.
• Women who are pregnant or breastfeeding, or individuals not willing to use birth control.
• Certain heart conditions or history of heart disease.
• Active infections like tuberculosis, uncontrolled HIV, or hepatitis.
• History of autoimmune diseases, except for certain stable conditions.
• Recent receipt of live vaccines.
• History of organ transplantation or certain lung conditions.