Phase 2 Melanoma Trial, Recruiting

Written by an AI model from the 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 aged 18 or older at the time of signing the consent form
• People who have been diagnosed with advanced melanoma (Stage III or Stage IV) that cannot be surgically removed and is not a type that starts in the eye, and where local treatments are not suitable
• People whose cancer can be measured on scans according to standard measurement guidelines (RECIST v1.1), including in areas that have previously been treated with radiation if the cancer has grown there
• People who are reasonably able to carry out daily activities, rated on a standard scale as 0, 1, or 2 (confirm with trial site for what these ratings mean)
• People with a life expectancy of at least 12 weeks
• People whose bone marrow, liver, and kidney function meet the required levels, including specific blood count, platelet, and kidney function results as assessed by the trial site
• People whose previous immunotherapy treatment (a type called PD-1/PD-L1, such as pembrolizumab) has stopped working and the cancer has progressed
• People who have recovered from most side effects of their previous pembrolizumab treatment to a mild level (Grade 1 or lower), with the exception of hormone-related side effects
• People who received PD-1/PD-L1 therapy within the 9 weeks before the first dose of the trial treatment
• People who are able and willing to use reliable contraception throughout the study and for 3 months after the final dose
• Women who could become pregnant must have had a negative pregnancy test within 7 days before starting treatment
• Male participants must agree not to donate sperm from the time they join the trial until 6 months after their last dose

Who may not be able to join:

• People whose melanoma started in or behind the eye (ocular or uveal melanoma)
• People who have had another type of cancer, with some exceptions: cancers that were fully treated and have not come back within 2 years, completely removed skin cancers (basal cell or squamous cell), certain slow-growing cancers that have never needed treatment, or completely removed early-stage cancers (carcinoma in situ)
• People who are not suitable to receive pembrolizumab again because they had a serious immune-related side effect (Grade 3 or higher) during previous treatment that caused them to stop that treatment
• People who have untreated or actively symptomatic cancer that has spread to the brain or the lining of the brain — though people with previously treated and stable brain metastases may be considered if specific conditions are met (confirm with trial site)
• People who have received other cancer treatments (apart from PD-1/PD-L1 therapy) within 6 to 9 weeks before the first trial dose
• People whose melanoma has a specific genetic change called a B-RAF mutation who have not yet tried the targeted treatments (BRAF and/or MEK inhibitors) available for that mutation, unless those treatments have been declined or cannot be tolerated
• People with a known active hepatitis B infection, unless it has been well controlled with antiviral medication for more than 4 weeks and viral levels are undetectable at screening
• People with a known active hepatitis C infection with detectable virus, unless they have been successfully treated and the virus is undetectable
• People with active HIV infection, unless it is well managed with medication and their immune cell count (CD4) is above 200 at screening
• People with a positive pregnancy test at screening
• People whose blood test results at screening fall outside the required ranges, including kidney function, liver markers (bilirubin, albumin), and immune cell counts, as assessed by the trial site
• People who have previously received an organ or tissue transplant from another person

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