Phase 2 Melanoma 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:

• Children and young people aged between 6 months and under 18 years old at the time consent is signed
• People with a confirmed diagnosis of an advanced or spreading solid tumour or lymphoma that cannot be cured and has not responded to standard treatments, or where no standard treatment exists or is considered suitable
• People who have had any number of previous cancer treatments
• People who have tumour tissue available from a previous biopsy sample, or who are able to have a new biopsy taken from a tumour that has not been previously treated with radiation
• People with advanced melanoma, or an advanced, returned, or treatment-resistant solid tumour or lymphoma that tests positive for a protein called PD-L1
• People whose cancer can be measured using standard imaging criteria (confirm with trial site for specific size requirements)
• People with a type of cancer called neuroblastoma where the disease can only be detected using a specific scan called a MIBG scan
• People who meet a minimum level of physical functioning, measured by an age-appropriate scale (Lansky or Karnofsky score of 50 or above)
• People whose major organs (such as kidneys, liver, and bone marrow) are functioning adequately
• Females who could become pregnant must have a negative pregnancy test within 72 hours before starting the study medication
• Females who could become pregnant must either abstain from heterosexual intercourse or use contraception during treatment and for at least 120 days after the last dose
• Male participants must follow local guidelines for contraception during clinical studies

Who may not be able to join:

• People currently taking part in another clinical trial or who have received an experimental treatment or used an experimental device within the past 4 weeks
• People with a diagnosed immune system deficiency, or who have taken steroid or other immune-suppressing medications within the past 7 days
• People who have received any systemic cancer treatment, including experimental treatments, within 2 weeks before the study start date, or who have not yet recovered from side effects of previous cancer treatment
• People who have had radiation therapy within 2 weeks before the study start date
• People with another cancer that is growing or requires active treatment, with some exceptions for certain skin cancers or early-stage cancers that can potentially be cured
• People with cancer that has spread to the brain or the lining around the brain and is currently active
• People with tumours located in the brain stem
• People who have had a severe allergic reaction (grade 3 or higher) to the study drug pembrolizumab or any of its ingredients
• People with an active autoimmune disease that has needed systemic treatment in the past 2 years (routine hormone replacement therapy is generally acceptable — confirm with trial site)
• People with a history of non-infectious lung inflammation that required steroid treatment, or who currently have lung inflammation
• People with an active infection that requires treatment with systemic medication
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the trial or within 120 days after the last dose
• People who have previously received certain types of immunotherapy drugs that target the immune system's checkpoint pathways (such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or similar treatments)
• People who are living with HIV
• People who have active hepatitis B or hepatitis C infection
• People with a known history of active tuberculosis (TB)
• People who have received a live vaccine within 30 days before the planned start of the study
• People who have had a solid organ transplant at any time, or a bone marrow or stem cell transplant from a donor within the past 5 years (people who had a donor stem cell transplant more than 5 years ago may be considered, provided there are no signs of a complication called graft versus host disease)
• People with any medical condition, ongoing treatment, or abnormal test result that could interfere with the study results or prevent full participation in the trial, or who have a known severe allergy to any component of the trial treatment
• People with known psychiatric conditions or substance use disorders that would prevent them from meeting the requirements of the study

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