Phase II Trial Comparing Ipilimumab and Nivolumab With or Without Stereotactic Radiotherapy in Patients With Melanoma Brain Metastases

What this Trial Is About

Researchers are evaluating treatments for patients with asymptomatic, untreated melanoma brain metastases in this phase II randomized trial. The study compares a combination of immunotherapy drugs, ipilimumab and nivolumab, given with or without stereotactic radiotherapy to the brain. This approach builds on earlier findings suggesting that combining these therapies may enhance the immune response against melanoma brain tumors and improve outcomes. Participants will receive combination treatment with ipilimumab and nivolumab according to approved dosing schedules. One group will also receive stereotactic radiotherapy to the brain within 7 days of a baseline MRI scan, while the other group will receive immunotherapy alone. Salvage therapies like surgery or radiotherapy may be used if brain disease progresses. The study aims to assess the effects of these treatments on survival, tumor response, neurocognitive function, quality of life, and side effects. During the study, participants will undergo brain MRIs, neurological and cognitive assessments, and complete quality of life questionnaires regularly. Blood, tissue, stool, and urine samples will be collected to study biomarkers related to treatment response and toxicity. Safety will be monitored through adverse event reporting. Participants will be followed for up to 10 years to evaluate neurological death rates, tumor response, survival, cognitive changes, and quality of life.

Anti-PD 1 Brain Collaboration + Radiotherapy Extension (ABC-X Study)