Phase 2 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 must be 18 years of age or older at the time of signing the consent form
• You have been diagnosed with a specific type of high-risk skin melanoma, confirmed by a tissue sample (biopsy), that falls into certain risk categories based on tumour thickness and/or a special test called the Merlin™ test
• You are able to have a procedure called a sentinel lymph node biopsy (a minor surgery to check nearby lymph nodes)
• There is no sign that the melanoma has spread to other parts of your body, based on scans and physical examination
• You have not previously received any systemic (whole-body) treatment for melanoma
• You are in reasonably good general health, as measured by a standard medical scoring system (confirm with trial site)
• Your kidneys, liver, and other organs are working well enough, according to standard medical tests
• Women must either be past menopause (no periods for 12 months without another medical reason), have had surgery that means they cannot get pregnant, or agree to use highly effective contraception during the trial and for at least 4 months after the last dose of treatment
• Women who could become pregnant must have a negative pregnancy test before starting and monthly throughout the trial until 4 months after the last dose
• Women must not be breastfeeding during the trial
• Men whose female partners could become pregnant must agree to use highly effective contraception from 14 days before the first dose until 16 weeks after the last dose, or have had a vasectomy
• You are able to understand and agree to the trial requirements and sign a consent form

Who may not be able to join:

• You have a type of melanoma that started in the eye (uveal), in mucous membranes (mucosal), or where the original site is unknown
• You have an active autoimmune disease (where your immune system attacks your own body) that requires ongoing medical treatment
• You have had another type of cancer in the past, unless it was a non-melanoma skin cancer, a specific type of in-situ (very early stage) cancer, or you have been in complete remission for at least 3 years and need no further treatment for it
• You have a known active infection with HIV, hepatitis B, or hepatitis C (people with laboratory evidence that hepatitis B or C has fully cleared may still be considered — confirm with trial site)
• You have a serious or unstable existing medical condition, mental health condition, or other issue that could affect your safety or ability to take part
• You have an active infection at the time of screening, such as a wound infection
• You have had a known severe allergic reaction to drugs similar to the study treatment or its ingredients
• You have previously received an organ transplant
• You have previously been treated with checkpoint inhibitor drugs (a type of immunotherapy)
• You have previously received a transplant of human cells, tissues, or organs, or are being considered for any type of transplant
• You have any other condition, treatment, or test result that, in your doctor's opinion, could interfere with the trial or would not be in your best interest
• You have a known psychiatric illness or substance use problem that would make it difficult to follow the trial requirements
• You are unable to have a whole-body PET/CT scan or MRI scan for any medical reason

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