Phase 2 Colorectal 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 aged 18 or older at the time of giving consent.
• People who have signed a consent form agreeing to take part and allowing their health information to be used.
• People whose general physical health and ability to carry out daily activities meets a certain standard, as measured within 30 days before joining (confirm with trial site what this means for a specific situation).
• People who have been confirmed through a tissue sample to have a specific type of anal cancer (invasive squamous cell carcinoma) at certain stages, or a more advanced stage if the tumour is smaller than 5cm in diameter.
• People whose treating doctor has determined them to be unsuitable for the standard chemotherapy treatment (5-fluorouracil and mitomycin-C given alongside radiation).
• People who have not yet received any treatment for their anal cancer diagnosis.
• People who have measurable disease that can be assessed using standard imaging criteria, confirmed within 30 days before joining.
• People who have tumour tissue available (either stored from a previous biopsy or newly collected) for research testing purposes.
• People whose blood test results show that their blood cells, kidneys, and liver are functioning at an acceptable level, confirmed within 30 days before joining.
• Women who could become pregnant and are sexually active with a male partner who could father a child must have a negative pregnancy test within 14 days before joining.
• Women who could become pregnant, and men who could father a child, must agree to either abstain from heterosexual activity or use effective contraception during the study.
• People living with HIV may be eligible if their HIV is well-controlled on medication, their immune cell count is at an acceptable level, the virus has been undetectable for at least 12 weeks, they have had no serious HIV-related infections in the past 12 months, and their HIV medication has been stable for at least 4 weeks before starting the trial.
• People with a history of hepatitis B must have an undetectable viral level while on suppressive treatment, if that treatment is needed.
• People with a history of hepatitis C must have completed treatment and been cured, or if still on treatment, must have an undetectable viral level.
• People who are able to understand and follow the study procedures for the full duration of the trial, as assessed by the enrolling doctor.

Who may not be able to join:

• People with serious uncontrolled illness, such as an active infection requiring medication, heart failure, unstable chest pain, irregular heartbeat, or a mental health or personal situation that would make it difficult to follow the study requirements.
• People who have another cancer that is still active or has required treatment within the past two years and is considered to carry more than a low risk of returning — though some exceptions apply (confirm with trial site for specific cancer types).
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the study or within 120 days after the last dose of the study treatment. Breast milk also cannot be stored for later use while on the study.
• People who have had a serious allergic reaction to pembrolizumab or any of its ingredients.
• People who have an active autoimmune disease that has required immune-suppressing treatment within the past two years.
• People diagnosed with an immune deficiency condition, or who have been taking immune-suppressing medications (including certain steroid doses above a set level) within 7 days before joining — though certain inhaled or skin-applied steroids are allowed.
• People who have received a live or live-weakened vaccine within 30 days before joining — examples include vaccines for measles, mumps, rubella, chickenpox, yellow fever, rabies, and some flu nasal sprays. No live vaccines are permitted during the trial either.
• People who have a history of, or currently have, a non-infectious lung condition (pneumonitis or interstitial lung disease) that required steroid treatment.
• People who have taken part in another clinical trial using an experimental drug or device for anal cancer within 30 days before joining.
• People who have previously had a bone marrow, stem cell, or solid organ transplant from another person.
• People who have not fully recovered from major surgery, or who have ongoing complications from surgery.
• People with any condition, treatment history, or lab result that the treating doctor believes could affect the study results or would not be in the person's best interest for participation.
• People with known psychiatric conditions or substance use disorders that would make it difficult to follow the trial requirements.
• People who have previously been treated with a type of immunotherapy called anti-PD-1 checkpoint blockade.
• People who are currently taking a medication that is not compatible with the study drugs and are unable to stop or switch to a different medication within 7 days of starting the trial.

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