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 years or older
• People diagnosed with melanoma that cannot be surgically removed or has spread to other parts of the body, and whose cancer has continued to grow or spread after at least one previous treatment that included an anti-PD-1 therapy (a type of immunotherapy)
• People willing and able to pause their anti-PD-1 treatment from the time they join the trial until approximately 6 weeks after first receiving the study treatment (DOC1021)
• People who have at least one tumour that can be biopsied or removed to provide enough tissue for the study treatment to be made, and at least one other measurable tumour remaining to track during the trial
• People with brain tumours that have spread from the melanoma, provided those tumours are stable following prior treatment
• People who are able to receive the medications and procedures involved in this trial, including a growth-stimulating injection (filgrastim), a blood cell collection procedure (leukapheresis), injections near lymph nodes, and weekly interferon injections for 4 weeks
• Women who could become pregnant must have a negative pregnancy blood test before joining and agree to use effective contraception throughout the study
• People whose kidneys, liver, bone marrow, and immune system are functioning at a level that meets the trial's minimum requirements (confirm specific blood test thresholds with the trial site)
• People with an overall health and activity level rated as fully active or restricted in strenuous activity only (ECOG score of 0 or 1)

Who may not be able to join:

• People who are currently pregnant or breastfeeding
• People with a known active HIV or hepatitis infection — although people with HIV that is well-controlled with undetectable virus levels, or people with a past hepatitis C infection that has been successfully treated with no detectable virus remaining, may still be considered eligible (confirm with trial site)
• People with severe or uncontrolled heart disease, autoimmune conditions requiring immune-suppressing medications (such as rheumatoid arthritis, psoriasis, or inflammatory bowel disease treated with certain medications), autoimmune thyroid conditions, untreated viral hepatitis, or autoimmune hepatitis — or any other serious uncontrolled medical condition that the trial doctor believes would affect safe participation
• People who still have significant side effects (greater than Grade 1) remaining from a previous immunotherapy treatment — although people who developed hormone-related side effects from prior immunotherapy may still be considered eligible if those are well-managed with replacement therapy (confirm with trial site)
• People who have received another experimental drug or participated in another experimental treatment within the last 30 days

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