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 of any gender, aged 18 to 99 years
• People who have been diagnosed with skin (cutaneous) melanoma, confirmed by a tissue sample examined in a lab — either early-to-mid stage (Stage I–III, Cohort 1) or advanced stage (Stage IV, Cohort 2)
• People who have at least one melanoma tumour that can be felt under the skin, has been confirmed by biopsy, is large enough to inject into (at least 1 cm across, measured by caliper or ultrasound), and has been photographically or sonographically documented
• People whose general health and ability to carry out daily activities meets a standard medical rating of 0 or 1 on a scale used by doctors (meaning fully active or able to carry out light activity)
• People whose recent blood test results (taken within 30 days before screening) show that blood cell counts, liver function, clotting time, kidney function, and bilirubin levels are all within the ranges required by the trial (confirm specific values with the trial site)
• Women who could become pregnant must agree to use effective contraception from the time of screening until a specified period after their last treatment dose — the required timeframe depends on which treatment group applies (confirm details with the trial site)
• Women are considered unable to become pregnant if they have been through menopause (no periods for 12 months without another medical cause), or have had a hysterectomy, both fallopian tubes tied, or both ovaries removed
• Acceptable contraception methods include: total abstinence from sex (when this is a person's normal lifestyle), condoms with spermicide, a diaphragm with spermicide, hormonal contraceptives (oral or implanted), or an intrauterine device — note that methods such as periodic abstinence or withdrawal are not considered acceptable by the trial
• Women who could become pregnant must have a negative pregnancy test (blood or urine) before joining
• People who are HIV-positive may still be considered if, within 30 days before enrolment, their immune cell counts and viral load meet the specific levels required by the trial (confirm with trial site)

Who may not be able to join:

• People with a known allergy or intolerance to flu (influenza) vaccines
• People who need to take corticosteroids at a dose higher than the equivalent of 10 mg of prednisone per day, or who take other medicines that suppress the immune system, within 14 days before starting the study treatment
• People with an active autoimmune disease (a condition where the immune system attacks the body), or a known or suspected one
• People whose melanoma has spread to the brain or to the lining around the brain or spinal cord, and is currently active
• People whose melanoma started in the eye or in the moist lining tissues of the body (mucosal melanoma), confirmed by biopsy
• People who have received any melanoma treatment within 6 months before joining — though prior surgery to remove melanoma is allowed
• People who are currently incarcerated
• Women who are pregnant or breastfeeding
• People who are not able to give their own consent to participate independently

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