Phase 3 Head and Neck Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You have been newly diagnosed with a specific type of head and neck cancer (called HNSCC) affecting the mouth, throat, voice box, or lower throat area, which cannot be surgically removed, and you have already completed a full course of chemotherapy (using a drug called cisplatin) combined with radiation therapy aimed at curing the cancer, with no signs that the cancer has spread to distant parts of the body.
• A tissue sample (biopsy) taken before your chemotherapy and radiation treatment showed a protein called PD-L1 on your cancer cells.
• If your cancer is in the oropharynx (the middle part of the throat), you must have had a specific lab test called p16 IHC performed on your tissue sample (confirm with trial site).
• You are generally able to carry out daily activities with no more than minor limitations — roughly what doctors call an ECOG score of 0 or 1 (confirm with trial site).
• Your kidneys, liver, blood, and other organs are working well enough to meet the trial's health requirements (confirm with trial site).

Who may not be able to join:

• You have previously had radiation, surgery, or other cancer treatments for your head and neck cancer that were separate from the chemotherapy and radiation treatment described above, or you received induction chemotherapy (chemo given before the main treatment).
• Your chemotherapy and radiation treatment included any drugs other than cisplatin and radiation, such as cetuximab or experimental drugs.
• Your cancer is located in the nasopharynx (upper throat, behind the nose), sinuses, or other nearby areas, or comes from an unknown primary site, or you have more than one separate head and neck cancer tumour.
• You previously had serious side effects from immunotherapy treatment, including severe reactions affecting the nervous system, skin, or heart, of any severity (confirm with trial site).
• You have had a major operation or a serious injury that has not yet fully healed by the time you would start the trial.
• You have a history of lung inflammation or scarring (interstitial lung disease or pneumonitis), either in the past or currently.
• You have liver cirrhosis at any stage, or you currently have unstable liver or bile duct disease with symptoms such as fluid build-up in the abdomen, confusion, yellowing of the skin, or related complications.
• You have another medical condition, ongoing treatment, or abnormal test result that the trial doctor believes could interfere with the study or affect your safety.
• You are currently receiving any other cancer treatment or taking part in another experimental therapy trial.
• You have previously been treated with a type of immunotherapy drug that targets PD-1, PD-L1, PD-L2, or similar immune system proteins (such as CTLA-4 inhibitors).
• You are currently pregnant, breastfeeding, or planning to become pregnant during the trial period and for 120 days after the last dose of the study drug.
• You have a history of severe allergic or anaphylactic reactions to similar types of antibody-based medicines, or you are known to be allergic to the study drug (dostarlimab) or any of its ingredients.

Important: Always verify eligibility with the trial site directly before applying.