Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
| OligoProgressive Metastatic Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- description
- This is a single-arm trial, meaning all participants will receive the same treatment. There is no control or comparison group. All eligible patients will continue their existing first-line systemic therapy and receive additional radiation treatment-either stereotactic body radiotherapy (SBRT) or hypofractionated radiotherapy-directed at oligoprogressive lesions. The outcomes will be measured and analyzed based on this single group.
- interventionNames
- Radiation: Stereotactic Body Radiation Therapy (SBRT)
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS) assessed by radiological imaging using RECIST v1.1 criteria
- timeFrame
- From enrollment up to 24 months
- description
- To determine if the addition of SBRT or hypofractionated radiation to progressive lesions improves progression-free survival in patients with metastatic melanoma. Radiological progression will be evaluated using CT, PET-CT, or MRI according to RECIST v1.1.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDIcht O, Sun A, Wong P, McPartlin A, Muniz TP, Spreafico A, Saibil SD, Lukens JN, Karam SD, De Almeida J, Butler MO, Tsai CJ. Consolidative use of radiotherapy to block oligoprogression in patients with metastatic melanoma on Systemic Therapy (CURB-Melanoma) - a single arm, phase 2 clinical trial. Front Oncol. 2026 Jul 6;16:1841070. doi: 10.3389/fonc.2026.1841070. eCollection 2026. PMID 42518820