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:

• People who have signed a consent form before any pre-screening steps take place.
• People who have been diagnosed through laboratory testing with head and neck cancer (specifically squamous cell carcinoma) that has come back or spread, is linked to a virus called HPV16, and cannot be cured with local treatments such as surgery or radiation.
• People whose tumor has a protein called PD-L1 at a level of 1 or higher (measured by a specific approved laboratory test).
• People who have not yet received any systemic (whole-body) cancer treatment for their cancer in its returned or spread form. People who received systemic treatment more than 180 days ago as part of treatment for an earlier, locally advanced stage of the disease may still be eligible (confirm with trial site).
• People whose cancer can be measured on scans according to a standard set of rules called RECIST 1.1, as confirmed by independent review.
• People who can provide a stored tumor tissue sample, or alternatively a fresh tissue sample taken as part of their normal care before starting the trial treatment. A sample from the area where the cancer has spread is preferred, but a sample from the original tumor site may also be accepted.

Who may not be able to join:

• People whose cancer started in the nasopharynx (the upper part of the throat, behind the nose), regardless of the type.
• People who have had another cancer that has not been fully in remission for at least 2 years — though some low-risk cancers (such as certain treated skin cancers, early-stage cervical, prostate, bladder, or breast cancers) may be exceptions (confirm with trial site).
• People who have been taking strong immune-suppressing medications, including certain steroid medicines at higher doses, in the 7 days before the first trial treatment dose.
• People who have recently received other immune-modifying treatments within 4 weeks (or longer, depending on the medication) before starting the trial drug, or whose side effects from those treatments have not fully resolved.
• People who have received a live vaccine within 4 weeks before the first dose of the trial drug.
• People who have taken part in another clinical trial or received an experimental drug or vaccine within 4 weeks (or longer, depending on the agent) before the planned start of the trial drug.
• People who are currently being treated with antibiotics taken by mouth or through a drip for an active infection. People taking antibiotics to prevent infection (for example, for a urinary tract infection or lung condition) may still be eligible (confirm with trial site).
• People who have previously received certain immune-based cancer treatments, such as PD-1 or PD-L1 blockers, cancer vaccines, or similar agents, within 4 weeks (or longer, depending on the agent) before the first trial treatment dose.
• People who have had non-systemic cancer treatments such as radiotherapy or surgery within 2 weeks before being enrolled into the trial.

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