Phase 1 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:

• People whose cancer has continued to grow or spread during or after standard treatment, or for whom no curative treatment is available (including those who have refused standard treatment, been considered unsuitable for it, or were unable to tolerate it).
• People who have previously been treated with certain immunotherapy drugs that target the PD-1 or PD-L1 pathways.
• People who have a stored tumour tissue sample available (a preserved block or slides), or who are able to provide a fresh tumour biopsy, so that gene testing can be carried out before enrolment.
• People with measurable tumours that can be tracked and assessed according to a standard set of medical measurement guidelines (confirm with trial site).
• People with head and neck squamous cell carcinoma joining certain parts of the trial who are willing to provide two tumour biopsies — one before treatment and one during treatment — from the same tumour, unless the treating doctor determines this is not feasible.

Who may not be able to join:

• People with active autoimmune diseases, other than certain conditions (vitiligo, type 1 diabetes, hypothyroidism, hypopituitarism, or mild psoriasis not needing systemic treatment), or people with a history of a primary immune system disorder, bone marrow transplant, or solid organ transplant.
• People with active inflammatory bowel disease, or those who have used biologic medicines or immune-suppressing medicines to treat it within the past two years.
• People who have received anti-cancer treatment — including chemotherapy, radiation, immunotherapy, or any experimental therapy — within 28 days (or within 5 half-lives of that drug, whichever is shorter) before the first dose of the study drug. Note: limited palliative radiation (10 or fewer sessions) to bones, skin, or painful spread of cancer is excepted (confirm with trial site).
• People who have had radiation treatment to brain tumours within 14 days before the first dose of the study drug.
• People who have recently taken certain medicines that strongly or moderately affect the way the body processes a liver enzyme called CYP3A, within 14 days or 5 half-lives of that medicine before starting the study drug.
• People who need to continue taking medicines that strongly or moderately affect CYP3A processing throughout the duration of the study.
• People who have consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or star fruit within 3 days before starting the study drug, or who would need to consume these while on the study.
• People who have used immune-suppressing medicines within 14 days before the first dose, with some exceptions: nasal sprays, inhaled medicines, skin creams, or local steroid injections are generally permitted, as are steroids used to prevent allergic reactions to procedures, or low-dose oral steroids up to the equivalent of 10 mg per day of prednisone (confirm with trial site).

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