Phase 1 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 who have been diagnosed with advanced melanoma that has spread to other parts of the body, confirmed by a tissue test.
• People aged 18 or older at the time of signing the consent form, of any gender.
• People whose treating doctor has planned for them to receive a type of immunotherapy (called PD-1 therapy, either alone or in combination with another immunotherapy), either restarting a previous immunotherapy regimen or moving to a combination treatment — and where this plan has been reviewed by the trial's lead doctor.
• People who have previously received immunotherapy (PD-1 based treatment, alone or in combination) and experienced a moderate to severe immune-related side effect affecting the bowel, liver, or skin (rated Grade 2 or higher) that caused treatment to be paused or stopped, or that required steroid treatment.
• People who have had more than one immune-related side effect from previous immunotherapy may still be eligible.
• People with blood test results showing the body's organs are functioning adequately — specifically, white blood cell counts, platelet levels, haemoglobin levels, and liver enzyme levels within the required ranges — based on tests taken within 42 days before consent (confirm with trial site).

Who may not be able to join:

• People whose melanoma started in the eye (uveal melanoma).
• People who are pregnant or breastfeeding.
• People with a known immune system disorder, or who are taking steroid medication at doses above the equivalent of 10 mg of prednisone per day, or any other medication that suppresses the immune system, within 7 days before the first research biopsy.
• People who have melanoma that has spread to the brain and is causing symptoms — though people with brain spread that is stable and not causing symptoms, and who do not need steroids for it, may still be considered.
• People with a history of, or currently having, non-infection-related lung inflammation (pneumonitis) that required steroid treatment.
• People with an active infection that requires treatment with medication given throughout the body (such as antibiotics taken by mouth or through a drip).
• People with a known history of HIV infection.
• People with a known history of Hepatitis B, or a currently active Hepatitis C infection (no additional testing for these is required by the trial).
• People with a known history of active tuberculosis (TB).
• People with any other medical condition, treatment history, or abnormal test result that the treating doctor believes could affect the study results or make participation not in the person's best interest (confirm with trial site).
• People with known psychiatric conditions or substance use disorders that would make it difficult to follow the trial requirements.
• People who have had an organ or tissue transplant from another person.
• People with a history of an autoimmune disease that required ongoing treatment within the past 12 months — except for immune-related side effects caused by immunotherapy.
• People who have been treated with the medication secukinumab within the last 12 months.
• People who have had a serious immune-related side effect from previous immunotherapy affecting the heart, nervous system, or eyes, or who have had a severe blistering skin reaction related to immunotherapy.

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