2109 - Consolidative Use of Radiotherapy to Block Oligoprogression in Patients with Metastatic Melanoma on Immunotherapy (CURB-Melanoma) - A Single Arm, Phase 2 Clinical Trial
Presenter(s)
O. Icht1,2, A. Y. Sun1,2, P. Wong1,2, A. McPartlin1,2, D. Hogg3, T. P. Muniz3, A. Spreafico3, S. Saibil3, M. O. Butler4, and C. J. Tsai1,2; 1Department of Radiation Oncology, University of Toronto, Toronto, ON, Canada, 2Radiation Medicine Program, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada, 3Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada, 4Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, ON, Canada
Purpose/Objective(s): Despite advances in systemic therapy for metastatic melanoma, resistance often develops at limited sites while the majority of disease remains controlled. This phase 2 trial investigates whether stereotactic body radiation therapy (SBRT) to oligoprogressive sites can improve progression-free survival (PFS) in metastatic melanoma patients receiving first-line systemic therapy.
Materials/Methods: This is an open-label, single-arm phase 2 trial. Eligible patients have metastatic melanoma with =10 extracranial oligoprogressive sites while on first-line immunotherapy. Oligoprogression is defined using modified RECIST 1.1 or PERCIST criteria. Patients are stratified by number of oligoprogressive sites (1-5 vs 6-10). All oligoprogressive sites receive SBRT per institutional guidelines, typically delivered over 1-5 fractions. The primary endpoint is PFS. Secondary endpoints include overall survival, time on current systemic therapy, out-of-field response, toxicity, and quality of life. Circulating tumor DNA (ctDNA) is collected at baseline, 8 weeks post-registration, and at progression as an exploratory endpoint. The trial aims to enroll 52 patients over 12 months with 24 months of follow-up. Assuming a baseline median PFS of 11.5 months with immunotherapy alone, the study is powered to detect an improvement in median PFS to 18.5 months with the addition of SBRT (80% power, a=0.05).
Results: TBD.
Conclusion: TBD.