Phase 3 Head and Neck Cancer Trial, Recruiting

Written by an AI model from 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 must be able to give written consent to participate voluntarily.
• You must be between 18 and 79 years old at the time of joining the trial.
• You must be generally well enough to carry out light activity and care for yourself (a doctor will assess this using a standard scoring system).
• Your doctors must expect you to live for at least 6 months at the time of joining.
• You must have a confirmed diagnosis of head and neck cancer that has come back or spread, with the original tumour located in the mouth, throat, voice box, or the area just below the throat.
• If your cancer is in the oropharynx (back of the throat), you must have had an HPV test done on your tumour tissue before joining.
• You must not have received any previous systemic (whole-body) treatment for your returned or spread head and neck cancer. However, if you had chemotherapy, radiotherapy, or certain targeted treatments aimed at curing an earlier stage of cancer, you may still be eligible if your cancer came back more than 6 months after finishing that treatment.
• You must have at least one area of cancer that can be clearly measured on a scan.
• Your tumour must test positive for a protein called PD-L1 (with a score of 1 or higher), confirmed by a laboratory test on tumour tissue.
• Your blood, kidney, liver, and clotting function must meet certain minimum levels shown by blood tests (confirm with trial site for specific values).

Who may not be able to join:

• Your cancer must not have started in the nose, nasal sinuses, salivary glands, thyroid or parathyroid glands, skin, or an unknown location.
• You must not have had another type of cancer in the last 3 years (although certain minor skin cancers or very early-stage cancers that were fully treated locally may be acceptable).
• You must not currently be taking part in another treatment-based clinical trial, or have received experimental treatment within the last 4 weeks.
• You must not have previously received any medication that targets the growth of blood vessels in tumours.
• You must not have had radiation treatment to the head and neck area for returned or spread cancer before.
• You must not have previously received any form of immunotherapy, such as checkpoint inhibitor drugs (e.g. anti-PD-1 or anti-CTLA-4 treatments), immune cell therapies, or cancer vaccines.
• You must not have open sores or skin wounds related to your cancer, or tumours that your doctor believes carry a high risk of bleeding, including recent tracheostomy (breathing hole in the throat) near the tumour.
• Scans must not show that your tumour is growing into important nearby structures such as the windpipe, food pipe, or major blood vessels in the neck in a way that could cause dangerous bleeding (confirm with trial site).
• You must not have cancer that has spread to the brainstem, the lining of the brain or spinal cord, or be causing spinal cord compression.
• You must not have received curative radiotherapy to the head and neck within the last 6 months, certain immune-boosting medications within the last 2 weeks, or palliative (pain-relieving) radiotherapy to other body areas within the last 3 weeks.
• You must not have an active autoimmune disease (where the immune system attacks the body) that has required ongoing medical treatment in the last 2 years.
• You must not have a weakened immune system, a known HIV-positive status, or be taking long-term steroids or other immune-suppressing medicines.
• You must not have had, or currently have, lung inflammation or scarring that has required steroid treatment, or a serious ongoing lung condition.
• You must not have had a serious infection requiring hospital treatment within the last 4 weeks, or an active infection requiring antibiotic or antiviral treatment within the last 2 weeks.

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