Study on Dostarlimab vs Placebo After Chemoradiation in Adults with Locally Advanced Head and Neck Cancer

Inclusion Criteria

• Newly diagnosed with locally advanced head and neck squamous cell carcinoma (HNSCC) in the oral cavity, oropharynx, hypopharynx, or larynx.
• Completed chemoradiation therapy (CRT) with cisplatin and radiotherapy aimed at curing the cancer.
• No evidence of cancer spreading to distant parts of the body.
• Provided a tissue sample showing PD-L1 positive tumor status.
• If the cancer is in the oropharynx, must have undergone p16 IHC testing.
• Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Have adequate organ function as determined by medical tests.

Exclusion Criteria

• Received any prior radiation, systemic, targeted therapy, or major surgery for head and neck cancer not part of CRT.
• Have cancer in areas outside the oropharynx, larynx, hypopharynx, or oral cavity, such as the nasopharynx or sinuses.
• Experienced severe side effects from previous immunotherapy, such as severe skin reactions, neurological events, or heart inflammation.
• Had major surgery or significant injury within 28 days before joining the study.
• Have a history of lung diseases like interstitial lung disease or pneumonitis.
• Have liver disease or cirrhosis with symptoms like fluid buildup, confusion, or jaundice.
• Have any medical condition or treatment that could interfere with the study or make participation unsafe.
• Are receiving any other cancer treatments or experimental therapies.
• Previously treated with drugs targeting PD-1, PD-L1, PD-L2, or similar immune system targets.
• Are pregnant, breastfeeding, or planning to become pregnant during the study and for 120 days after the last dose.
• Have severe allergies to similar drugs or known allergies to Dostarlimab or its ingredients.