Phase 3 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:

• People who test positive for a specific genetic marker called HLA-A*02:01
• People who have melanoma (not of the eye) that cannot be removed by surgery and has been classified as Stage III or Stage IV
• People who are able to provide either a stored tumor tissue sample or a new biopsy from a tumor area that has not been treated with radiation
• People whose disease can be measured or tracked using standard imaging criteria (confirm with trial site)
• People whose general health and ability to carry out daily activities meets a specific fitness score (a score of 0 or 1 on a standard scale used by doctors)
• People who are able and willing to use highly effective contraception, if this applies to their situation
• People who are willing and able to give signed consent and follow the study's requirements
• People who agree to provide blood or tissue samples for research testing during the trial

Who may not be able to join:

• People who are pregnant or breastfeeding
• People who have a type of eye-related melanoma called ocular or metastatic uveal melanoma
• People who have had another type of cancer (other than the melanoma being studied in this trial)
• People who are not able to receive further treatment with the drug pembrolizumab due to a serious side effect from a previous course of that treatment
• People who have untreated or symptomatic cancer that has spread to the brain or the lining around the brain
• People who have had a serious allergic reaction to another type of antibody-based medicine in the past
• People who have an active autoimmune disease that currently requires treatment to suppress the immune system
• People who have a known psychiatric condition or substance use disorder
• People who have previously been treated with a specific type of experimental cancer medicine called an ImmTAC drug, or who have not waited long enough after stopping certain other medicines (confirm with trial site)
• People who have received chemotherapy or certain other cancer medicines within 14 days before the first dose (some exceptions apply — confirm with trial site)
• People who have received cell-based therapies within 90 days before starting the study treatment
• People who have ongoing significant side effects from previous treatments, rated at a certain level of severity, that in the treating doctor's opinion could affect the study results
• People who have received steroid treatment or other immune-suppressing medicines within 2 weeks before the first dose
• People whose cancer has not progressed after treatment with a type of immunotherapy medicine called an anti-PD(L)1 antibody
• People who have not previously been treated with an approved type of immunotherapy medicine called an anti-CTLA-4 antibody
• People who have a specific gene change called a BRAF V600 mutation and have not previously been treated with a specific type of targeted therapy for that mutation
• People who are currently taking part in, or have taken part in, another clinical trial or used an investigational device within 30 days of the first dose
• People with a known history of chronic viral infections such as hepatitis B or hepatitis C
• People with known serious heart or lung disease or significantly reduced heart or lung function
• People whose blood test results fall outside acceptable ranges (confirm with trial site)
• People who have received an organ or tissue transplant from another person

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