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 metastatic melanoma (melanoma that has spread) that can be measured or seen either by physical examination or by imaging scans.
• People who are 18 years of age or older.
• People who have signed and dated an approved consent form agreeing to take part in the study, with the understanding that they may withdraw at any time.
• People who are largely able to carry out daily activities with little or no restriction, as measured by a standard health performance scale (ECOG score of 0 or 1).
• People whose melanoma tissue has tested positive for both a protein called tyrosinase and a specific immune marker called HLA-A2, confirmed through a biopsy.
• People whose heart pumping function is greater than 50%, as confirmed by a heart ultrasound scan done during screening.
• People who previously received a type of immunotherapy called anti-CTLA-4 treatment may be eligible if at least 6 weeks have passed since their last dose and there is evidence that the cancer has continued to grow.
• People who previously received a type of immunotherapy called anti-PD-1 or anti-PD-L1 treatment may be eligible if at least 4 weeks have passed since their last dose and there is evidence that the cancer has continued to grow.
• People whose melanoma has a specific gene change called a V600E mutation may be eligible if a BRAF inhibitor or MEK inhibitor therapy has already been tried and stopped working, or if that treatment was offered but declined.
• People who have previously been treated with a medication called Interleukin-2 (IL-2) may be eligible.
• People who have sufficient heart and lung function to safely receive IL-2, as determined by the treating institution's guidelines.

Who may not be able to join:

• People who are pregnant, breastfeeding, or are of reproductive potential and have not agreed to use an effective form of contraception during the study; the trial also excludes fetuses, children, prisoners, and people in institutional care.
• People whose daily functioning is significantly limited by their illness, as indicated by an ECOG performance score of 2 or higher.
• People with a history of melanoma that has spread to the brain, if that brain disease is currently active or was active within the past three months and was not controlled by surgery or radiation therapy.
• People who are currently taking steroid medications to control their disease or manage pain.
• People whose melanoma has a BRAF V600 mutation and are currently responding well to BRAF inhibitor treatment (with or without a MEK inhibitor), or who have that mutation but have not yet been offered the option of receiving those treatments.
• People who have had another cancer in the past, with certain exceptions: adequately treated skin cancers (basal cell or squamous cell), cervical cancer that has not spread beyond the surface, a Stage I or II cancer that is now in complete remission, or any other cancer from which the person has been cancer-free for at least two years.
• People who have previously received immunotherapy that specifically targeted the tyrosinase protein.
• People who have previously received immunotherapy combined with a mild form of chemotherapy designed to partially suppress the bone marrow.
• People with certain abnormal blood test results, including low white blood cell counts, low platelet counts, elevated liver function markers, abnormal kidney function, low protein levels, abnormal blood clotting levels, or elevated liver enzyme levels (confirm specific values with the trial site).
• People who currently have an active infection that requires antibiotic treatment.
• People with severe or poorly managed ongoing health conditions, such as high blood pressure, significant heart, lung, or metabolic disease, poor wound healing, active ulcers, or bone fractures.
• People who have received chemotherapy or any experimental treatment within 4 weeks before the study start date.
• People with a known infection with HIV, hepatitis B (HBV), or hepatitis C (HCV).
• People with a known allergic reaction to any ingredient in the study medications.
• People who the trial investigator believes would be unable or unwilling to follow the requirements of the study.

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