A Phase II Randomised Trial of Stereotactic Ablative Body Radiotherapy Combined with Immunotherapy Versus Immunotherapy Alone in Patients With Treatment-Naïve Oligometastatic Extracranial Melanoma

What this Trial Is About

Researchers are evaluating whether adding stereotactic body radiotherapy (SBRT) to standard immunotherapy improves treatment outcomes for patients with advanced or metastatic melanoma that has spread outside the brain. This Phase II trial explores if combining precise radiotherapy with immune checkpoint inhibitors enhances anti-tumor immune response and prolongs survival compared to immunotherapy alone. The study is based on promising early data showing potential synergy between radiation and immunotherapy in various cancers, including melanoma. Participants will be randomly assigned to one of two groups: one receiving concurrent SBRT plus standard first-line immunotherapy, and the other receiving immunotherapy alone. SBRT delivers high doses of radiation precisely to 1 to 5 extracranial metastatic sites over several days between the first and third cycles of immunotherapy. Immunotherapy will be administered as per current standard care protocols approved by regulatory agencies. The trial aims to assess the safety and effectiveness of this combined approach versus immunotherapy alone. During the study, participants will undergo regular assessments including imaging scans to measure tumor response, blood tests, and quality of life questionnaires over a five-year period. Researchers will monitor overall survival, progression-free survival, local tumor control, adverse events, and the need for additional treatments. Safety and tolerability of the treatments will also be closely tracked. The total time participants are involved may extend up to five years to evaluate long-term outcomes and effects of the therapies.

Stereotactic Ablative Radiotherapy (XRT) and Immunotherapy for Oligometastatic Extracranial Melanoma