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:

• People who have been diagnosed with either cutaneous melanoma (skin cancer) or synovial sarcoma (a type of soft tissue cancer) that cannot be surgically removed or has spread to other parts of the body
• People who have tested positive for a specific immune system marker called HLA-A*02:01
• People whose major organs (such as kidneys, liver, and heart) are functioning well enough to meet the trial's requirements
• People who are generally well enough to carry out daily activities with little or no difficulty (confirm with trial site for exact fitness level required)
• People whose cancer can be measured on scans according to standard criteria
• People with a life expectancy of more than 5 months
• People with cutaneous melanoma whose cancer has continued to grow or who experienced unacceptable side effects during or after treatment with at least one PD-1 inhibitor (a type of immunotherapy drug)
• People with synovial sarcoma who have already received at least one prior treatment (or have chosen not to), and whose cancer still requires further treatment
• Female participants who are able to become pregnant must use adequate contraception from before joining the trial until 12 months after receiving the main treatment (IMA203), and for 15 days after the last dose of a related medicine (mRNA 4203)

Who may not be able to join:

• People who have had another type of cancer in the last 3 years (with some exceptions for certain common skin cancers or early-stage cancers that were fully treated)
• People who are currently pregnant or breastfeeding
• People with a serious autoimmune disease (where the body's immune system attacks its own tissues)
• People with certain heart conditions (confirm with trial site for specific details)
• People who have previously had a bone marrow or stem cell transplant from a donor, or a transplanted solid organ (such as a kidney or liver)
• People with a severe or uncontrolled medical condition that could make participation unsafe
• People who have had a serious allergic reaction to the medicines cyclophosphamide, fludarabine, or IL-2, which are used as part of the treatment process
• People who have had a serious allergic reaction to any medicine based on mRNA technology
• People who are living with HIV, or who have an active hepatitis B or hepatitis C infection
• People who have a condition that would prevent a procedure called leukapheresis, where blood cells are collected from the body
• People whose blood levels of a substance called lactate dehydrogenase (LDH) are above the limit set by the trial (confirm with trial site for the specific threshold)
• People who have active cancer that has spread to the brain at the time of starting the treatment preparation phase
• People already taking part in another clinical trial or device trial that could interfere with this treatment
• People who have both reduced kidney function and a reduced ability to produce blood cells from bone marrow, meeting specific levels set by the trial (confirm with trial site for details)

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