Focused radiotherapy to control a few growing melanoma spots

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

This trial tries adding stereotactic or short-course radiotherapy to up to ten extracranial melanoma spots that are starting to grow while patients stay on their current systemic therapy to see if it delays overall disease progression.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 52 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Health Network, Toronto (Academic / other)
• Drugs / interventions: immunotherapy, radiation
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT07112170 on ClinicalTrials.gov

What this trial studies

This is an open-label, prospective, single-arm Phase II trial that treats up to ten extracranial oligoprogressive melanoma lesions with stereotactic body radiotherapy (SBRT) or hypofractionated radiotherapy while patients continue first-line systemic therapy. All oligoprogressive sites that can be safely targeted are treated, and patients are followed with imaging to track disease progression. Blood samples are collected at baseline, after radiation, and at progression for exploratory analyses. Outcomes include progression-free survival, overall survival, time on current therapy, toxicity, quality of life, and out-of-field response.

Who should consider this trial

Good fit: Adults with metastatic melanoma on first-line immunotherapy or BRAF-targeted therapy who have up to ten extracranial oligoprogressive lesions and an ECOG performance status of 0–2.

Not a fit: Patients with more than ten extracranial progressing sites, leptomeningeal disease, contraindications to radiotherapy, or lesions that cannot be safely treated with SBRT are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, this approach could extend the time patients benefit from their current systemic therapy by controlling the few sites that are starting to grow.

How similar studies have performed: Similar SBRT approaches for oligoprogression or oligometastatic disease have shown promise in other cancers and in early melanoma reports, but large randomized evidence in metastatic melanoma is limited.

Eligibility criteria

Inclusion Criteria:

* Age 18 or older
* ECOG 0-2
* Willing and able to provide informed consent
* Metastatic melanoma detected on imaging and clinically confirmed.
* Treated with first line immunotherapy or BRAF inhibitors.
* No upper limit to the number of total metastatic sites, but a maximum of ten progressive metastatic sites, inclusive of primary disease and metastatic lesions, all of which must be extra cranial.
* Patients who had any prior radiation therapy near or overlapping with the oligoprogressive sites are allowed to enroll.
* All sites of oligoprogression that can be safely treated with SBRT or hypofractionated radiotherapy.

Exclusion Criteria:

* \>10 extracranial sites of progressive disease.
* Pregnancy.
* Leptomeningeal disease.
* Serious medical comorbidities precluding radiotherapy, such as ataxia-telangiectasia or scleroderma.
* Prior radiotherapy near the oligoprogressive lesion precluding SBRT or hypofractionated radiotherapy due to exceeding OAR tolerance.
* Any psychological, sociological or geographical issue potentially hampering compliance with the study.
* Any other condition which in the judgment of the investigator would make the patient inappropriate for entry into this study.

Where this trial is running

Toronto, Ontario

• University Health Network — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Study coordinator: Jillian C Tsai, MD

Conditions Metastatic Melanoma; OligoProgressive Metastatic Disease; stereotactic body radiation therapy; Melanoma