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:

• Adults aged 18 or older
• People diagnosed with melanoma that cannot be surgically removed (stage III) or that has spread to other parts of the body (metastatic)
• People who have received at least one dose of a combination treatment called ipilimumab-nivolumab as their first treatment for this melanoma, and whose doctor considers them suitable to continue on a maintenance (ongoing) treatment with nivolumab or pembrolizumab
• People whose melanoma has shown a partial or complete response (meaning the tumour has shrunk or disappeared) on scans, assessed using a standard measurement system called RECIST v1.1
• People who meet the above response criteria within 9 months of starting ipilimumab-nivolumab treatment, with inclusion occurring no later than 5 weeks after that response is confirmed
• People who are willing and planned to stop nivolumab within approximately 4 weeks of joining the trial
• People who have had a brain MRI scan to check for cancer spread to the brain, done before stopping ipilimumab-nivolumab
• People who have previously had brain metastases (cancer spread to the brain) that were treated locally may be considered, provided the brain metastases are completely symptom-free at the time of joining and the person is able to undergo regular brain MRI scans during the trial
• People who have signed and dated a consent form agreeing to take part

Who may not be able to join:

• People whose melanoma has not responded to treatment or has continued to grow, based on RECIST v1.1 scan assessment
• People who currently have another active cancer (exceptions may apply for cancers that were fully treated and have not come back within the past 2 years, completely removed basal cell or squamous cell skin cancers, or completely removed early-stage cancers that had not spread)
• People who had brain metastases causing symptoms before starting ipilimumab-nivolumab, or who have new or worsening brain metastases at the time of joining, or whose brain metastases have required steroid medication within the 8 weeks before joining (note: a single seizure caused by a brain lesion is not automatically disqualifying — confirm with trial site)
• People with cancer that has spread to the lining around the brain and spinal cord (leptomeningeal metastases)
• People taking ongoing steroid medication at a dose above 10mg per day of prednisone or equivalent, or people who needed strong immune-suppressing medications (such as infliximab or mycophenolate mofetil) to manage side effects from immunotherapy (note: local steroids such as skin creams, inhalers, nasal sprays, or eye drops are generally permitted — confirm with trial site)
• People whose personal, family, social, or geographic circumstances may make it difficult to follow the study schedule and attend required appointments

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