Phase 1 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 been clinically diagnosed with head and neck cancer that has come back and requires regional treatment.
• People with oropharyngeal (throat) cancer whose tumour has been tested for HPV using a specific lab method (p16 IHC) and shown a positive result.
• People who can provide at least 10 stored tissue slides from a previous biopsy, or who are willing to have a new biopsy taken before joining the trial.
• People with head and neck squamous cell carcinoma (a specific type of cancer) that has returned or is a new primary cancer, has been previously treated with radiation, and has not spread to distant parts of the body — or has spread only in small amounts to a limited number of sites that could potentially be treated with focused radiation or other curative treatments such as surgery.
• People who completed prior radiation treatment at least 4 months before joining, or completed chemotherapy, immunotherapy, or targeted therapy at least 1 month before joining, and who have recovered from any side effects of those treatments.
• People who have previously received PD-1 or PD-L1 checkpoint inhibitor therapy (a type of immunotherapy).
• People who have previously received chemotherapy.
• People who had surgery to remove a tumour but were found to have high-risk features (such as cancer cells at the surgical margins or spread to nearby lymph nodes), and who have been determined by a specialist medical team to be suitable for further radiation treatment.
• People aged 18 years or older.
• People who are generally well enough to carry out everyday activities with little or no limitation, as measured by a standard medical scale (ECOG performance status of 0 or 1).
• People with a life expectancy of more than 12 weeks.
• People whose kidneys, liver, bone marrow, and other organs are functioning within acceptable ranges, as confirmed by blood tests reviewed by the study doctor.
• People who test negative for pregnancy at the start of the study (applies to those who could become pregnant).
• Women who could become pregnant and agree to use highly effective contraception during treatment and for 6 months after the last dose of study medication.
• Men who are sexually active with women who could become pregnant and agree to use contraception (including condoms) during treatment and for 6 months after the last dose of study medication.
• People who are able to understand the study and are willing to sign a written consent form.

Who may not be able to join:

• People who have never received any prior treatment for their cancer and whose disease is limited to the local or regional area only.
• People who received chemotherapy within the 4 weeks before joining, or who have not yet recovered from side effects of earlier chemotherapy.
• People who are currently taking part in another clinical trial involving an experimental treatment.
• People who have a known history of allergic reactions to drugs with a similar chemical make-up to the study medications.
• People who have needed to take high-dose corticosteroids (such as prednisone at more than 10 mg per day) or other immune-suppressing medications within 14 days before starting the study — though low-dose, topical, inhaled, or short-course steroid use for non-immune conditions may be acceptable (confirm with trial site).
• People who have a known allergy or sensitivity to either of the study drugs (tislelizumab or pamiparib) or any other medications used in this trial.
• People with a known history of active tuberculosis.
• People with another cancer that is currently growing or requires active treatment — with some exceptions, such as certain treated skin cancers, cervical cancer in situ, very slow-growing cancers unlikely to affect life expectancy within 3 years, or a prior history of certain blood cancers (confirm with trial site).
• People with an active autoimmune disease that has required systemic treatment (such as steroids or immune-suppressing drugs) within the past year — though hormone replacement therapies such as thyroid medication or insulin are not considered systemic treatment for this purpose.
• People with a known history of, or currently active, lung conditions such as interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis, or other uncontrolled lung diseases.
• People with a known history of HIV infection.
• People with known active Hepatitis B or Hepatitis C infection — though people whose Hepatitis C has been fully cleared may be eligible (confirm with trial site).
• People who have received a live vaccine within 28 days before starting the study — most seasonal flu injections are allowed, but live nasal spray flu vaccines and any live COVID-19 vaccines are not.
• People with serious uncontrolled ongoing illnesses, including active infections, uncontrolled heart failure, unstable chest pain (angina), uncontrolled irregular heartbeat, or mental health or social circumstances that would make it difficult to follow the study requirements.
• People with known cancer that has spread to the brain.
• People currently taking certain strong medications that affect how the liver processes drugs (called strong CYP3A inducers — examples include carbamazepine, phenytoin, rifampin, and phenobarbital), or who are taking herbal supplements such as St. John's Wort.
• People who are pregnant, as the study medications may harm an unborn baby.
• People who are breastfeeding.
• People living with HIV who are on antiretroviral therapy, due to potential drug interactions and increased infection risk.
• People with significant digestive system problems that affect how the body absorbs medications — such as part of the stomach or small bowel having been surgically removed, certain bariatric (weight loss) surgeries, active inflammatory bowel disease, bowel obstruction, or bowel perforations or fistulas.

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