Phase 2 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 diagnosed with a specific type of throat cancer (oropharyngeal squamous cell carcinoma) at an early stage (Stage I or II), confirmed by a tissue or cell sample from either the main tumour or a nearby lymph node, and where surgery to remove the cancer is planned and agreed to.
• People whose cancer has tested positive for HPV (human papillomavirus), including any high-risk HPV type.
• People aged 18 years or older.
• People with a general health status rated as reasonably functional (confirm with trial site for exact definition).
• Current smokers who have smoked fewer than 10 pack-years in total. Former smokers who quit more than 10 years ago are eligible regardless of smoking history. Former smokers who quit less than 10 years ago must have smoked fewer than 10 pack-years.
• People whose blood counts and organ function (kidneys, liver, blood cells) meet specific healthy ranges, as measured by blood tests (confirm with trial site for exact values).
• People living with HIV, provided they have been on effective HIV treatment for at least 4 weeks, have an undetectable viral load, have an adequate immune cell count, and have had no serious HIV-related infections in the past 12 months.
• People with Hepatitis B or Hepatitis C, provided their viral load is undetectable.
• People who are able to become pregnant must agree to use highly effective contraception during treatment and for a defined period after the last dose of each study drug.
• Men must agree to use highly effective contraception during treatment and for a defined period after the last dose of each study drug, and it is recommended that their female partners of childbearing potential also use highly effective contraception during this time.
• People who are breastfeeding must be willing to stop breastfeeding from the start of treatment through to 2 months after the last dose of the study drug.
• People who have a tumour location that can be safely biopsied and who are willing to have a biopsy taken before treatment begins, for research purposes.
• People who are willing to have a PET/CT scan (a type of full-body imaging scan) before treatment begins.
• People who are able to understand the study information and are willing to sign a written consent form.

Who may not be able to join:

• People who have moderate or severe nerve damage affecting movement or sensation (confirm with trial site for exact grading).
• People who have received an experimental drug, live vaccine, chemotherapy, immunotherapy, or radiation therapy (other than palliative treatment to bones) within 4 weeks before the first study treatment.
• People who have taken certain medications that significantly affect how the body processes drugs (moderate or strong CYP3A inducers or inhibitors) within 2 weeks before the first study treatment (confirm with trial site for specific medications).
• People with a history of serious allergic reactions to drugs with a similar make-up to those used in this trial.
• People who have taken high-dose steroid medications or other immune-suppressing drugs within 1 week before the start of treatment (low physiologic doses may be acceptable — confirm with trial site).
• People who have had another active cancer within the past 2 years, unless it is a minor or fully treated cancer considered cured and not requiring further treatment (such as certain skin cancers or early cervical changes).
• People who have previously received a transplant of donor tissue or a solid organ (such as a kidney or liver).
• People with a history of heart failure.
• People who are pregnant (a pregnancy test will be conducted at screening for those who are able to become pregnant).
• People with other serious, unstable health conditions — for example, those who have recently been hospitalised, visited an emergency department, or are currently undergoing significant medication changes — that could increase the risk of participating in the trial.

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