Phase 2 Study of Radiation Therapy Targeting Limited Progression to Delay Disease Worsening in Patients With Metastatic Melanoma

What this Trial Is About

Researchers are evaluating the use of stereotactic body radiotherapy SBRT or hypofractionated radiotherapy to treat oligoprogressive lesions in patients with metastatic melanoma. This open-label, single-arm Phase II trial focuses on patients who have up to ten extracranial progressing sites while continuing their first-line systemic therapy. The goal is to see if targeting these progressing lesions can delay overall disease progression and extend the benefit of ongoing treatment. All participants will continue their current systemic therapy and receive SBRT or hypofractionated radiotherapy directed at all oligoprogressive lesions. This study does not include a comparison group instead, all patients receive the same treatment. Radiation will be delivered according to institutional standards, and treatment focuses on safely targeting the limited sites of disease progression. Participants will be monitored through imaging studies to assess disease progression, and blood samples will be collected at baseline, after radiation, and at progression for further analysis. The study will track progression-free survival as the primary outcome over 24 months, along with overall survival, time on current therapy, toxicity, quality of life, and participant-reported adverse events. The full participation period spans up to 24 months with regular assessments.

Consolidative Use of Radiotherapy to Block Oligoprogression in Patients With Metastatic Melanoma