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:

• People aged 18 or older who have been diagnosed with melanoma that cannot be surgically removed or has spread to other parts of the body, confirmed by laboratory testing of tissue.
• People whose cancer can be measured on scans according to standard criteria (called RECIST v1.1), including those who have had radiation therapy, provided measurable cancer exists outside the treated area or has clearly grown since radiation ended.
• Male participants who agree to use contraception during treatment and for 9 months after the last dose of one study drug (EV) or 4 months after the last dose of the other (pembrolizumab), whichever is later, and who agree not to donate sperm during this period.
• Female participants who are not pregnant and not breastfeeding, and who either cannot become pregnant or agree to use contraception for 12 months after the last dose of EV or 4 months after the last dose of pembrolizumab, whichever is later.
• People who have already received previous treatment for their advanced melanoma, including at least two doses of a specific type of immunotherapy (anti-PD-1/L1), and whose cancer has been confirmed to have progressed during or after that treatment within 12 weeks of the last dose.
• People with a BRAF gene mutation in their melanoma who have already received both targeted therapy (BRAF/MEK inhibitors) and immunotherapy (PD-1/PD-L1 treatment).
• People whose side effects from previous cancer treatments have mostly resolved to mild or baseline levels (with specific allowances for certain hormone-related side effects and mild nerve-related symptoms).
• People who can provide a tumour tissue sample (either stored from a previous biopsy or a new sample, if safe to obtain).
• People who are generally well enough to carry out light activities, as assessed by a standard health scale (ECOG score of 0 or 1), measured within 7 days before starting treatment.
• People whose organs (such as kidneys, liver, and bone marrow) are functioning adequately, confirmed by blood tests taken within 10 days before starting treatment.

Who may not be able to join:

• Women who could become pregnant and have a positive pregnancy test within 72 hours before being assigned to the trial.
• People who have previously received the study drug enfortumab vedotin or any other cancer treatment from the same drug class (MMAE-based ADCs).
• People who have received any systemic cancer treatment, including experimental treatments, within 4 weeks before the planned start date.
• People who have received radiation therapy within 2 weeks before starting the trial, or who still have side effects from radiation that require steroid medication (a short course of palliative radiation with a 1-week gap may be allowed — confirm with trial site).
• People who have received a live or live-weakened vaccine within 30 days before the first dose (non-live vaccines are permitted).
• People who have used any other experimental treatment or device within 4 weeks before starting the trial.
• People with poorly controlled diabetes, defined by specific blood sugar markers (HbA1c of 8% or above, or 7–8% with associated symptoms).
• People with an immune system deficiency, or who are taking steroid medication at a dose above 10 mg of prednisone per day, or any other medication that suppresses the immune system, within 7 days before the first dose.
• People who have another cancer that is currently active or has required treatment within the past 2 years (some skin cancers that have been successfully treated may be excepted — confirm with trial site).
• People with currently active cancer that has spread to the brain or the lining of the brain, unless the brain metastases were previously treated, have been stable on scans for at least 4 weeks, and have not required steroid treatment for at least 14 days.
• People who have had a severe allergic reaction (Grade 3 or above) to either of the study drugs or their ingredients.
• People with active eye conditions affecting the cornea, such as active keratitis or corneal ulcers (mild superficial eye conditions that are being treated may be allowed — confirm with trial site).
• People with an active autoimmune disease that has needed systemic medical treatment in the past 2 years (hormone replacement therapies such as thyroid medication or insulin are generally excepted).
• People who have had serious lung inflammation (pneumonitis or interstitial lung disease) that required steroid treatment, or who currently have this condition.
• People with an active infection that requires systemic treatment.
• People with a known history of HIV infection.
• People with both active Hepatitis B and active Hepatitis C infections at the same time.
• People who have not fully recovered from a major surgery or who have ongoing complications from surgery.
• People with known psychiatric conditions or substance use disorders that would make it difficult to participate in the trial requirements.
• People who are pregnant, breastfeeding, or planning to conceive a child during the required contraception period.
• People who have received a donor organ or tissue transplant.
• People with a history of active tuberculosis.
• People who had severe skin-related side effects (Grade 3 or above) from previous cancer treatments.
• People whose overall health or circumstances, in the treating doctor's judgement, would make participation not in their best interest or could affect the reliability of the trial results.

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