Phase 1 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:

• You are 18 years of age or older
• You have given written consent to take part in the study
• You have been diagnosed with one of the following cancers that cannot be surgically removed or has spread, confirmed by tissue testing: skin melanoma; triple-negative breast cancer (TNBC); a type of lung cancer called non-squamous NSCLC; synovial or myxoid round cell sarcoma; osteosarcoma; colorectal cancer that tests positive for NY-ESO-1 or MAGE-A3 markers; or other advanced sarcoma that tests positive for those same markers
• Your cancer has come back or got worse after standard treatment, or you were unable to tolerate or chose not to have standard treatment
• You are eligible for, or already receiving, a type of cancer treatment called checkpoint inhibitor (CPI) therapy
• Your cancer can be measured using standard imaging scans
• You have a tumor that doctors believe can be safely biopsied and injected
• You are generally well enough to carry out light activity and care for yourself (confirm with trial site what this means for your situation)
• Your liver and kidney blood test results are within an acceptable range
• Your blood counts (red cells, white cells, and platelets) are within an acceptable range
• Your blood clotting results are within an acceptable range
• If you are a woman who could become pregnant, you have tested negative for pregnancy before starting the trial and agree to use highly effective contraception during the study and for a set period afterward
• If you have previously had checkpoint inhibitor therapy, you have had a break of at least 6 weeks since your last treatment with a PD-1 or PD-L1 type drug

Who may not be able to join:

• You have received an oncolytic virus treatment or a live virus vaccine within the past 4 weeks
• You have taken strong immune-suppressing medicines (including high-dose steroids, equivalent to more than 10 mg/day of prednisone) within the past 4 weeks — though inhaled or skin-applied steroids are allowed
• You have had radiotherapy within the past 4 weeks
• You have taken part in another clinical trial using an experimental drug or device within the past 4 weeks
• You currently have an active infection (bacterial, viral, or fungal) that needs treatment with systemic medicines
• You have an active autoimmune disease that has needed systemic treatment at any point in the past two years
• You have another medical condition that the trial doctor believes would put you at unacceptable risk or interfere with the study (confirm with trial site)
• You are taking blood-thinning medication that cannot safely be paused for the trial injections and biopsies, in your doctor's opinion
• You have a known infection with HIV, hepatitis B, hepatitis C, or active tuberculosis
• You have active cancer spread to the brain that is causing symptoms, or cancer spread to the membranes around the brain or spinal cord — note: people with brain metastases that are not causing symptoms and who have been off steroids and seizure medicines for at least 7 days may still be eligible (confirm with trial site)
• You have previously had a severe or serious reaction to a PD-1 or PD-L1 type drug, or had certain serious side effects such as severe lung inflammation, severe bowel inflammation, or severe liver enzyme elevations from immunotherapy
• You have had, or are planned to have, an organ or tissue transplant
• You are pregnant, breastfeeding, or planning to become pregnant during the study period
• You are a male planning to father a child during the study period
• You are unwilling or unable to follow the study procedures for any reason
• You are being held in an institution by a court or government order
• You work for the study sponsor, research organisation, or the trial site and are directly involved in this study
• You have or have had another cancer, unless your doctor confirms it will not affect the safety or results of this trial (confirm with trial site)

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