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 or older, of any gender.
• People with a life expectancy of more than 3 months, in the opinion of the study doctor.
• People who are able and willing to sign a consent form (or have a legally authorised representative sign on their behalf).
• People who have been diagnosed with metastatic uveal melanoma (a type of eye cancer that has spread), whether it is a first presentation or has come back, confirmed by tissue testing.
• People with metastatic melanoma of the skin, mucous membranes, or unknown origin that has been confirmed by tissue or cell testing, including advanced stage III (inoperable) or stage IV disease — including those whose melanoma came back after being at a lower stage.
• People with non-uveal metastatic melanoma who have previously received anti-PD1 immunotherapy (nivolumab or pembrolizumab), either alone or in combination with another treatment, and whose disease got worse after that treatment.
• People whose melanoma has a specific gene change called BRAF V600 mutation who have previously received BRAF-targeted therapy and whose disease got worse afterwards — or people who refused, could not tolerate, or chose to delay BRAF-targeted therapy (confirm with trial site).
• People with a good general level of physical function, rated 0 or 1 on a standard scale used by doctors (meaning fully active or able to carry out light work).
• People who have measurable areas of disease that can be tracked on scans, according to standard measurement guidelines.
• People with normal kidney, liver, and blood cell function as defined by the trial's specific tests.
• People whose urine protein levels fall within acceptable limits as measured by specific urine tests outlined in the trial (confirm with trial site for exact levels).
• People whose heart function, as measured by an echocardiogram (heart ultrasound) done at the start of the trial, is within the normal range as determined by a cardiologist.
• People taking blood-thinning medication (such as warfarin) at full doses may be eligible if their blood-thinning levels are stable and within the target range, and they have no active bleeding or high risk of bleeding (confirm with trial site).
• People who have not previously received treatment for metastatic uveal melanoma, as well as those who have had prior treatments — with no limit on how many prior treatment courses are allowed, as long as they have not previously received bevacizumab, aflibercept, or cemiplimab.
• People who have no active brain metastases (cancer that has spread to the brain), confirmed by a contrast-enhanced scan within 4 weeks before joining — those with previously treated brain metastases that were adequately managed with radiation or surgery may be eligible (confirm with trial site).
• Women who could become pregnant and who agree to use highly effective contraception for at least 2 or more menstrual cycles before the study starts, throughout the study, and for at least 180 days after the last dose of study drugs.
• Men who could father a child and who agree to use condoms or other effective contraception for at least 1 month before the study starts, throughout the study, and for at least 180 days after the last dose of study drugs.

Who may not be able to join:

• People who are pregnant or breastfeeding.
• People who have received another experimental drug or systemic treatment for uveal melanoma within 4 weeks before starting the study drugs, or who have had radiotherapy within the past 4 weeks.
• People who have not yet recovered from side effects of previous cancer treatments.
• People who have had major surgery within 4 weeks before joining, or who have not fully recovered from surgery, or who have a significant active infection.
• People who currently need ongoing treatment with steroid tablets or other immune-suppressing medications for autoimmune conditions or immune disorders — though occasional use of steroid inhalers is allowed, and replacement steroids for adrenal insufficiency are also allowed. People who have stopped these medications at least 2 weeks before joining may be considered eligible at the study doctor's discretion.
• People with a history of certain autoimmune diseases that have caused symptoms, such as rheumatoid arthritis, lupus, scleroderma, Sjögren's syndrome, autoimmune vasculitis, Guillain-Barré Syndrome, Myasthenia Gravis, Multiple Sclerosis, or similar conditions.
• People who have taken immune-suppressing doses of steroids (more than 10 mg of prednisone daily or equivalent) within 4 weeks before the first dose of study treatment — though short courses for specific purposes such as contrast allergy prevention are not excluded, and replacement doses for adrenal insufficiency are not excluded.
• People who have previously had a stem cell transplant (either from a donor or using their own cells).
• People who have permanently stopped immune-based cancer treatments because of serious side effects from those treatments.
• People who have had brain inflammation (encephalitis or meningitis) or uncontrolled seizures in the past year.
• People with a history of lung inflammation (pneumonitis) related to the immune system within the past 5 years.
• People with a history of certain lung diseases such as pulmonary fibrosis or organising pneumonia, or active non-infectious lung inflammation that required high-dose steroid treatment — though a history of radiation-related lung inflammation that resolved at least 6 months ago is allowed.
• People who have had a solid organ transplant (such as a kidney or liver transplant) — though people who have had a corneal (eye) transplant are not excluded.
• People who have a history of inflammatory bowel disease or diverticulitis (a history of diverticulosis, which is milder, is allowed).
• People with other significant medical, surgical, or psychiatric conditions, or who need medications that the study doctor believes could interfere with treatment or make it unsafe (confirm with trial site).
• People who currently have an active infection that requires intravenous antibiotic treatment.
• People with heart-related conditions including heart failure, coronary artery disease symptoms, a heart attack within the past 6 months, serious irregular heartbeats, or unstable chest pain (angina).
• People who have had a stroke or mini-stroke (TIA) within the past 6 months.
• People with a serious or slow-healing wound, ulcer, or bone fracture.
• People who have had a bowel fistula, bowel perforation, or abdominal abscess within 4 weeks before starting the study.
• People who have had major surgery, an open biopsy, or a significant injury within 4 weeks before the first day of study treatment, or who are expected to need major surgery during the trial.
• People who have had a minor surgical procedure or needle biopsy within 7 days before the first day of study treatment (though certain types of central venous lines may be placed at specific times — confirm with trial site).
• People with significant cardiovascular or cerebrovascular (blood vessel) disease, including uncontrolled high blood pressure, a recent heart attack or bypass surgery, severe heart failure, significant blood vessel disease in the limbs, or a blood clot (such as a deep vein thrombosis or pulmonary embolism) within the past 6 months.
• People with a history of serious bleeding related to their tumour, a bleeding disorder, or a blood clotting problem.
• People with an elevated blood-clotting test result (PT INR above 1.5), unless they are taking full-dose warfarin and meet the conditions described in the inclusion criteria.
• People who currently have another active cancer — though people who have been free of other cancers for more than 3 years, or who have a history only of certain early-stage or skin cancers, may be eligible (confirm with trial site).
• People who have received a live vaccine within 28 days before joining the trial.
• Women who could become pregnant or men who could father a child who are unwilling to use effective contraception as described in the inclusion criteria.

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