Phase 2 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 who have been diagnosed with advanced head and neck cancer, or cancers of the sinuses, nasolacrimal (tear duct) area, or skull base, confirmed by a tissue biopsy.
• People whose cancer is an HPV-independent head and neck squamous cell cancer at a certain stage (cT2–cT4, N0–N3) where organ-preserving surgery may be possible based on how the cancer responds to treatment.
• People whose cancer is an HPV-associated head and neck squamous cell cancer with specific imaging findings showing spread outside the lymph nodes, within certain stage limits (cT1–cT3 tonsil or one side of the base of tongue, N0–N1, up to 4 affected nodes).
• People with certain sinonasal or skull base cancers, including sinonasal carcinomas, HPV-associated sinonasal cancer, sinonasal undifferentiated carcinoma, or neuroendocrine sinonasal tumors, within certain stage limits (cT2–cT4, N0–N3).
• People whose cancer is specifically caused by HPV type 16 only — cancers linked to other HPV types are not eligible.
• People for whom there are at least 8 stored tissue slides available from their biopsy, or who are willing to have a new biopsy if slides are not available (unless the trial doctor waives this requirement).
• People being treated with the goal of curing the cancer.
• People whose cancer meets specific staging criteria under either the AJCC 7th or 8th edition staging systems, within certain size and spread limits (confirm with trial site).
• People in the surgical treatment group whose cancer is considered operable based on initial scans and examination, and who have no more than mild spread outside the lymph nodes (Grade 1 radiographic extranodal extension).
• People whose cancer can be measured on scans according to standard criteria (RECIST 1.1).
• People who have not previously received systemic (whole-body) cancer treatment, radiation therapy, or experimental treatments for their current cancer.
• People who have not had their cancer fully removed by surgery within the 8 weeks before joining (a biopsy or partial removal with remaining disease is acceptable).
• People with a good general health status — rated ECOG 0–1 or Karnofsky score 70% or above.
• People whose blood test results meet specific minimum levels for platelets, white blood cells (neutrophils), and haemoglobin, without needing a recent transfusion or injections to boost red blood cells (confirm specific values with trial site).
• People whose liver function blood tests are within acceptable limits (confirm with trial site).
• People with an albumin (a blood protein) level of at least 2.5 mg/dL.
• People whose kidney function is adequate, with a creatinine clearance of at least 60 mL/min.
• People whose blood clotting results are within acceptable limits, or who are on blood thinners and within their prescribed therapeutic range.
• People who are able to understand and sign the trial's informed consent form.
• Women who could become pregnant must have a negative pregnancy test within 72 hours before the first treatment dose.
• Women who could become pregnant must not be breastfeeding and must agree to use highly effective contraception (less than 1% failure rate) during treatment and for 120 days after the last dose.
• Men must agree to use adequate contraception, including a condom, during treatment and for 120 days after the last dose.
• All participants must receive counselling about pregnancy prevention as part of the trial.

Who may not be able to join:

• Women who could become pregnant and have a positive pregnancy test within 72 hours before treatment begins.
• People who are pregnant, breastfeeding, or planning to conceive or father a child during the study or within 120 days after the last dose.
• People who have previously been treated with certain immune checkpoint therapies, including PD-1, PD-L1, or PD-L2 inhibitors, or similar drugs that affect the immune system's T-cells (such as CTLA-4 or CD137 targeting agents).
• People who have already received systemic cancer treatment or radiation therapy for their current cancer (prior surgery is allowed if the person has sufficiently recovered).
• People who have received radiation therapy within 2 weeks before the start of the study (a shorter 1-week gap may be allowed in specific limited circumstances — confirm with trial site).
• People who have received a live or live-attenuated vaccine (including live COVID-19 vaccines) within 30 days before the first study dose.
• People currently taking part in another experimental treatment study, or who have done so within 4 weeks before joining (unless only in a follow-up phase).
• People with an immune system deficiency, or who are taking more than 10 mg per day of prednisone (or equivalent steroid) or other immune-suppressing medication within 7 days before starting the study drug.
• People with an active autoimmune disease that has needed systemic treatment within the past 2 years (hormone replacement therapies for thyroid, adrenal, or pituitary conditions are generally acceptable — confirm with trial site).
• People who have had a severe allergic reaction (Grade 3 or above) to Toripalimab or similar anti-PD-1 drugs.
• People with another active cancer requiring treatment within the past 2 years, with some exceptions for certain low-risk or treated cancers (confirm with trial site).
• People with active cancer spread to the brain or the lining of the brain and spinal cord. People whose primary tumour has grown into the skull may still be eligible; people with previously treated, stable brain metastases may also be considered (confirm with trial site).
• People with a history of lung inflammation (pneumonitis) or scarring of the lungs (interstitial lung disease) that required steroid treatment, or who currently have either condition.
• People with an active infection that requires treatment with antibiotics or other systemic medications.
• People known to have HIV infection.
• People with active Hepatitis B or active Hepatitis C infection (people whose Hepatitis B or C has been cleared or successfully treated may still be eligible — confirm with trial site).
• People with any other health condition, treatment, or abnormality that the trial doctor believes could affect the safety or accuracy of the trial, or that would not be in the person's best interest.
• People with a known psychiatric illness or substance use issue that could make it difficult to follow the trial requirements (stable, managed conditions may be acceptable — confirm with trial site).
• People who have previously received a transplant of tissue or a solid organ from another person.
• People with significant heart conditions, including severe heart failure (NYHA Class III or IV), unstable chest pain, serious uncontrolled heart rhythm problems, a heart attack within the past 6 months, or a prior history of heart muscle inflammation (myocarditis).

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