NCT07112170

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

Consolidative Use of Radiotherapy to Block Oligoprogression in Patients With Metastatic Melanoma (CURB-Melanoma) - a Phase 2 Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This open-label, prospective, single-arm Phase II trial explores whether adding stereotactic body radiotherapy (SBRT) or hypofractionated radiotherapy to oligoprogressive lesions can help delay disease progression in patients with metastatic melanoma. Participants may have up to ten extracranial oligoprogressive sites, with no upper limit on the total number of metastatic lesions. The study aims to assess whether targeting these progressing sites with focused radiotherapy can extend progression-free survival in this patient population.

Detailed description

This study evaluates the use of stereotactic body radiotherapy (SBRT) or hypofractionated radiotherapy in patients with metastatic melanoma who have up to 10 extracranial oligoprogressive lesions while receiving first-line systemic therapy. Oligoprogression refers to progression at a limited number of sites, while the remaining disease remains controlled by systemic treatment. Participants will continue their current systemic therapy and receive SBRT or hypofractionated radiotherapy to all oligoprogressive lesions. The study will assess whether this approach can delay overall disease progression and extend the duration of benefit from ongoing systemic therapy. Imaging will be used to monitor disease progression, and blood samples will be collected at baseline, after radiation, and at disease progression for exploratory analysis. Additional outcomes include overall survival, time on current therapy, toxicity, quality of life, and out-of-field response.

Conditions

• Metastatic Melanoma
• OligoProgressive Metastatic Disease

Interventions

Type	Name	Description
RADIATION	Stereotactic Body Radiation Therapy (SBRT)	SBRT will be delivered as per institutional standard.

Timeline

• Start date: 2025-07-24
• Primary completion: 2027-07-24
• Completion: 2028-07-24
• First posted: 2025-08-08
• Last updated: 2026-03-05

Locations

1 site across 1 country: Canada