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 who have measurable metastatic melanoma (melanoma that has spread) with at least one tumour that can be surgically removed to grow specialised immune cells in the lab.
• People whose melanoma diagnosis has been confirmed by the National Cancer Institute's (NCI) pathology laboratory.
• People who have already received at least one previous treatment for their metastatic melanoma.
• People who have 3 or fewer small tumours in the brain (each less than 1 cm across) that are not causing symptoms, including those who have had those brain tumours surgically removed, or those whose brain tumours were treated with a type of focused radiation and have been stable for at least one month since that treatment.
• People aged 18 to 72 years old (inclusive).
• People who are willing and able to sign a written consent form and a document that allows someone else to make decisions on their behalf if needed.
• People who are in generally good physical condition — able to carry out daily activities without significant limitation (confirm with trial site for exact fitness level required).
• People who are willing to use birth control from the time of joining the trial until at least four months after treatment ends.
• People whose blood tests show they are negative for HIV, hepatitis B, and hepatitis C (or, if a hepatitis C antibody test comes back positive, a further test must confirm the virus is not actively present in the blood).
• People who are able to become pregnant must be willing to have a pregnancy test before treatment begins.
• People who are able to become pregnant must agree to use highly effective contraception (such as hormonal methods, an IUD, abstinence, or surgical sterilisation) from the start of the study, throughout treatment, and for 12 months after the last dose of chemotherapy. They must also not donate or retrieve their own eggs from the start of treatment through to at least 12 months after the final study drug dose.
• People who are able to father children must agree to use effective contraception (such as barrier methods, surgical sterilisation, or abstinence) during treatment and for 4 months after the last chemotherapy dose, and must not freeze or donate sperm for at least 12 months after the final study drug dose.
• People who are currently breastfeeding must be willing to stop breastfeeding from the start of treatment through to 4 months after the last dose of study medication.
• People whose blood count results meet specific minimum levels for white blood cells, neutrophils (a type of white blood cell), platelets, and haemoglobin (confirm with trial site for exact values).
• People whose blood chemistry results (including liver enzymes, kidney function, and bilirubin levels) fall within acceptable ranges as determined by the trial (confirm with trial site for exact values).
• People who have finished any previous systemic (whole-body) treatments before joining the trial.
• People whose disease is getting worse at the time of treatment — though people who have taken certain targeted therapy drugs and whose disease is stable may also be considered (confirm with trial site).
• People who are also enrolled in a specific related NCI study (protocol 03-C-0277).

Who may not be able to join:

• People who are currently pregnant or breastfeeding.
• People who have any form of primary immune system deficiency (a condition where the immune system does not work properly from birth or early life).
• People who currently have an active opportunistic infection (a serious infection that takes advantage of a weakened immune system).
• People who have an active serious infection currently requiring treatment, active blood clotting disorders, or other serious active major medical conditions.
• People who have a history of a major organ being affected by an autoimmune disease (a condition where the immune system attacks the body's own tissues).
• People who are currently taking steroid medications that affect the whole body.
• People who have had a severe allergic reaction to any of the medications used in this trial.
• People who have previously had a severe (grade 3 or 4) immune-related side effect affecting a major organ that was linked to certain immunotherapy treatments (anti PD-1/PD-L1 drugs) — though these individuals may still be considered for a different treatment group within the trial (confirm with trial site).
• People who have a history of a procedure to restore blood flow to the heart (such as bypass surgery or stenting), or who have had symptoms of reduced blood flow to the heart.
• People who, based on their medical history, require a heart function assessment and whose heart pumping ability is found to be at or below a certain low level (confirm with trial site).
• People who, based on their medical history, require a lung function assessment and whose lung capacity is found to be at or below a certain low level (confirm with trial site).
• People who are currently participating in another clinical research study involving an experimental treatment.

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