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 years or older.
• People with melanoma that has been confirmed by a tissue or cell sample, and that cannot be surgically removed, has spread locally, or has spread to other parts of the body.
• For the earlier phases of the trial (Phase I and Phase IIa): people whose melanoma has not responded to standard treatments, or for whom no standard treatment is available. For the later phase (Phase IIb): people who may or may not have received standard treatment previously.
• People who have at least one tumour that can be measured using standard imaging criteria (called RECIST 1.1).
• People who are generally well enough to carry out daily activities, based on a standard performance scale (ECOG score of 0 or 1).
• People who are expected to survive for at least 3 months.
• People whose liver, kidneys, and other organs are functioning well enough to meet the trial's requirements (confirm with trial site for specific values).
• People of childbearing potential who agree to use reliable contraception during the trial and for 6 months after the last dose. Women of childbearing potential must have a negative blood pregnancy test within 7 days before starting the trial.
• People who are willing to take part voluntarily and sign a consent form.

Who may not be able to join:

• People who have received chemotherapy, radiotherapy, biological therapy, hormone therapy, targeted therapy, immunotherapy, or other unapproved trial treatments within the 4 weeks before starting the trial.
• People who have previously received a type of immune therapy involving IL-2 or IL-15 cytokines.
• People who have had major surgery (not including needle biopsies) or a serious injury within the 4 weeks before starting the trial, or who are expected to need planned surgery during the trial.
• People who have taken steroid tablets or other medicines that suppress the immune system within the 14 days before starting the trial — with some exceptions, such as low-dose steroids for hormone replacement, topical or inhaled steroids, or short-term steroids used to prevent allergic reactions (confirm with trial site).
• People with active cancer that has spread to the brain or the lining of the brain. People with stable brain metastases that do not currently need treatment may still be considered eligible.
• People with active infections that required intravenous (drip) antibiotic or antiviral treatment within the 14 days before starting the trial.
• People with a history of serious heart or stroke-related conditions.
• People with active or recurring autoimmune diseases (conditions where the immune system attacks the body).
• People who have previously had serious immune-related side effects from immunotherapy — specifically, side effects rated grade 3 or higher, or grade 2 or higher inflammation of the heart muscle linked to immunotherapy.
• People who have experienced a blood clot in an artery or vein within the 6 months before starting the trial.
• People who have needed drainage of fluid build-up in the abdomen or around the lungs within the 14 days before starting the trial.
• People who have had another type of cancer within the past 5 years, or who currently have another cancer alongside their melanoma.

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