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:

• People who have been confirmed by tissue or cell testing to have squamous cell carcinoma (a type of cancer) starting in the head or neck area (not including the nasopharynx or a skin-based type called cuSCC).
• People whose cancer has come back and for whom doctors consider standard first-line treatment with pembrolizumab, with or without chemotherapy, to be appropriate.
• People who have no known history of cancer that has spread to distant parts of the body.
• People whose tumours include at least one lesion that can be reached for a specific light-based treatment procedure and can be measured using standard imaging criteria.
• People who have not previously been treated with anti-PD-1 or anti-PD-L1 immunotherapy medicines.
• People whose tumour has a Combined Positive Score (CPS) of 1 or higher, as measured by an approved test (this is a measure of certain proteins on cancer cells).
• People with oropharyngeal cancer who have had their tumour tested for human papillomavirus (HPV) status.
• People who are assessed as having a good level of general physical functioning at the time of screening, rated 0 or 1 on a standard medical scale.
• People with adequate blood count, kidney function, and liver function at the time of screening.
• Women who could become pregnant must have a negative pregnancy test at screening and must agree to use highly effective contraception throughout the study and for 180 days after the last dose of treatment, or must be surgically sterile or abstaining from heterosexual activity. Male participants must agree to use highly effective contraception from the first dose through 120 days after the last dose.

Who may not be able to join:

• People who have been diagnosed with or treated for another cancer within the past 2 years, unless that cancer was a low-risk type such as certain skin cancers, early cervical cell changes, localised prostate cancer, or non-invasive breast changes. People with a history of another cancer that was fully removed by surgery and shows no signs of return may still be considered after discussion with the trial's Medical Monitor.
• People who have had a severe (Grade 3 or higher) reaction to a medicine called cetuximab in the past.
• People who have previously received an organ or tissue transplant from another person.
• People with known or active cancer spread to the brain or the membranes around the brain or spinal cord.
• People with a life expectancy of less than 3 months.
• People with an active autoimmune disease (where the immune system attacks the body) that has needed systemic treatment within the past 2 years. Note: hormone or gland replacement therapies are not considered systemic treatment for this purpose.
• People with a lung condition called interstitial lung disease, or currently active, non-infection-related inflammation of the lungs.
• People with an active infection currently requiring systemic treatment such as antibiotics, antifungals, or antivirals.
• People with a known or active serious infection including tuberculosis, active Hepatitis B, active Hepatitis C, or HIV/AIDS.
• People who have had significant bleeding from a tumour (Grade 3 or higher) within 12 weeks before joining the trial.
• People with serious uncontrolled ongoing health conditions, including but not limited to severe heart failure, unstable chest pain, irregular heart rhythms, or mental health or personal circumstances that would make it difficult to follow the study requirements.
• People who have received chemotherapy, targeted drug therapy, or radiation therapy within 2 weeks of starting the trial, or who have not yet sufficiently recovered from side effects of previous treatment.
• People who have received an anticancer antibody therapy or an experimental treatment within 4 weeks of starting the trial, or who have not yet sufficiently recovered from side effects of previous treatment.
• People who have previously received the study drug ASP-1929 at any time.
• People who are currently receiving ongoing steroid therapy at doses above a certain level (equivalent to more than 10 mg per day of prednisone), or any other immune-suppressing therapy, within 14 days before joining the trial.
• People who have received a live vaccine within 4 weeks of joining the trial. Most standard flu injections are allowed, but nasal spray flu vaccines are not.
• People who will need procedures within 4 weeks after the study's light-based treatment that involve significant exposure to light (such as certain eye examinations, unrelated surgical procedures, or endoscopies), as this could interact with the treatment.
• People who have had major surgery or a serious injury within 4 weeks before joining the trial, or who are expected to need major surgery during the course of the study.

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