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 been diagnosed with advanced or inoperable melanoma (not including uveal melanoma, which is a type that starts in the eye)
• People who are reasonably active and able to care for themselves, as measured by a standard health scoring scale (ECOG score of 2 or below)
• People whose blood, organ function, and lab results meet the levels set out in the study protocol (confirm with trial site)
• People whose blood pressure is adequately controlled, below 150 systolic and 100 diastolic
• People who have at least one tumour that can be measured on scans, according to standard criteria used in cancer trials
• People whose melanoma has stopped responding to, or who could not tolerate, a type of immunotherapy called an anti-PD-1 or PD-L1 inhibitor — either when used for advanced disease, or as a preventive treatment if the cancer came back during or within 6 months of finishing that treatment
• People with a specific gene mutation in their melanoma (BRAFV600) who have previously received BRAF/MEK inhibitor therapy, or who could not tolerate those drugs
• People who have received any number of prior treatments, except that prior treatment with a drug called ipilimumab is not permitted
• People whose side effects from previous treatments have settled to a mild level (Grade 2 or lower) or returned to their normal baseline
• People who have had or currently have another cancer, where that cancer or its treatment is not expected to interfere with this trial's assessments (as determined by the treating doctor)
• People who have had at least 2 weeks pass since any major surgery before starting the study treatment
• People who are able to have a tumour biopsy taken before treatment starts and again during treatment
• Women of childbearing potential who have a negative pregnancy test before starting, and who — along with male participants — agree to use highly effective contraception throughout the trial; pregnant or breastfeeding women are not permitted to join
• People with brain metastases (cancer that has spread to the brain) may be eligible, provided those metastases have already been treated, are stable, and do not require steroid medications
• People with an autoimmune disease that does not currently require disease-modifying medication; hormone or physiologic replacement therapy is permitted
• People living with HIV who are on effective treatment and have had an undetectable viral load at their most recent test within the past 90 days
• People with a past hepatitis C (HCV) infection who have been fully treated and cured, or who are currently being treated and have an undetectable viral load before the study starts

Who may not be able to join:

• People with known liver cirrhosis who also have severe liver impairment (classified as Child-Pugh C)
• People who have had a serious bleeding episode (Grade 3 or higher) within the past 4 weeks
• People who have had severe or unstable chest pain (angina) or significant heart failure symptoms within the past 6 months
• People who have had a stroke or a mini-stroke (transient ischemic attack) within the past 6 months
• People who are currently taking, or are expected to need, certain medications or foods that strongly interact with a liver enzyme called CYP3A4/5 — including having taken such substances within 10 days before treatment begins (confirm with trial site for specific medications)

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