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:

• Adults aged 18 or older.
• People with a confirmed diagnosis of advanced or metastatic melanoma (Stage IIIB-D or Stage IV) that has come back, and where a surgical specialist has determined the tumour can be removed or potentially removed.
• People whose melanoma came back and was confirmed by biopsy while receiving, or within 3 months of finishing, a specific type of immunotherapy called anti-PD1 given after surgery (adjuvant therapy).
• People who are generally well enough to carry out everyday activities with little or no limitation (this is measured using a standard medical scale called ECOG, score 0 or 1).
• People whose blood counts, liver function, and kidney function meet the minimum levels required by the trial (confirmed through blood tests at the trial site).
• People who are not able to become pregnant, or who test negative for pregnancy before joining, or who have gone through menopause or permanent surgical sterilisation — with specific requirements depending on age (confirm with trial site).
• People who are able to become pregnant, or whose sexual partner is able to become pregnant, must agree to use a highly effective form of contraception throughout the trial.
• People who have recovered from most or all side effects of any previous cancer treatments before starting the trial.
• People who are able to understand the study information and willing to sign a consent form agreeing to take part.

Who may not be able to join:

• People who have previously received a type of immunotherapy that targets CTLA4.
• People currently taking part in another clinical trial, or who have done so within the past 28 days before starting this study.
• People who have received systemic cancer treatment within 14 days (or within five half-lives of the drug, whichever comes first) before starting this study.
• People who have had radiation therapy within 45 days before starting this study.
• People who have had major surgery within 4 weeks before starting this study, or who have not fully recovered from major surgery.
• People who currently have an active infection requiring antibiotic treatment taken throughout the body.
• People who are taking steroid medications above a low daily threshold dose, or any other medication that suppresses the immune system, within 7 days before joining the trial.
• People with another active cancer, unless it is not expected to affect the safety assessment of this trial (confirm with trial site).
• People with known cancer spread to the brain or surrounding brain tissue.
• People with serious uncontrolled heart or cardiovascular conditions, including severe heart failure, unstable chest pain, serious heart rhythm problems, a stroke or heart attack within the past 3 months, certain abnormal heart readings on an ECG, a known inherited heart condition affecting heart rhythm, reduced heart pumping function, or blood pressure that remains at or above 140/90 despite treatment.
• People with any other medical, physical, social, or psychological condition that the trial doctor believes would make participation unsafe or prevent the person from following the study requirements.
• People living with HIV who have had a detectable amount of virus in their blood within the past 6 months — though people with HIV whose virus is undetectable on effective treatment may be eligible (confirm with trial site).
• People with active tuberculosis, active hepatitis B (confirmed by a specific blood test), or active hepatitis C — though people with past resolved hepatitis B infection, or hepatitis C where a specific further test is negative, may be eligible (confirm with trial site).
• People with medical, psychiatric, cognitive, or other conditions that may prevent them from understanding the study information, giving consent, or following the study procedures.
• People who have previously had a severe allergic reaction (Grade 3 or higher) to the study drug or any of its ingredients.
• People currently taking certain medications that are not permitted during this trial — a washout period of at least five half-lives of those medications is required before starting (confirm with trial site for the specific list of prohibited medications).

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