Metastatic MelanomaCURB-MelanomaNCT07112170
Consolidative Use of Radiotherapy to Block Oligoprogression in Patients With Metastatic Melanoma
A study testing Stereotactic Body Radiation Therapy (SBRT) in people with Metastatic Melanoma and OligoProgressive Metastatic Disease, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma, OligoProgressive Metastatic Disease
- What is being tested?
- Stereotactic Body Radiation Therapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- 24 Jul 2025to 24 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- >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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario
Jillian C Tsai, MD, 416-946-4501 ext. 4866, jillian.tsai@uhn.ca
About this study
Official title: Consolidative Use of Radiotherapy to Block Oligoprogression in Patients With Metastatic Melanoma (CURB-Melanoma) - a Phase 2 Clinical Trial
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.
Read the 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.
- Being tested
- Stereotactic Body Radiation Therapy (SBRT)
- Keywords
- stereotactic body radiation therapy (SBRT), Melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation Therapy (SBRT)Radiation
SBRT will be delivered as per institutional standard.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | 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. Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) assessed by radiological imaging using RECIST v1.1 criteria
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.
Measured: From enrollment up to 24 months
Secondary outcomes (6)
Overall Survival (OS) measured from date of enrollment to death from any cause
Measured: Enrollment up to 24 months
Time on Current Systemic Therapy After Initial Oligoprogression
Measured: From enrollment up to 24 months
Out-of-field response assessed by radiological imaging (CT, PET-CT, or MRI)
Measured: From enrollment up to 24 months.
Reporting acute and late toxicities of SBRT
Measured: Enrollment up to 24 months
Participant-reported adverse events measured using PRO-CTCAE questionnaire
Measured: From baseline through follow-up (up to 24 months)
Participant-reported quality of life measured using EORTC QLQ-C30 questionnaire
Measured: From baseline through follow-up (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start24 Jul 2025
- Primary completion24 Jul 2027 (estimated)
- Study completion24 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112170
- Sponsor's protocol ID
- 25-5162
- Acronym
- CURB-Melanoma
- Status last verified
- Mar 2026
- First submitted
- 29 Jul 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Icht 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.
PubMed 42518820
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consolidative Use of Radiotherapy to Block Oligoprogression in Patients With Metastatic Melanoma (CURB-Melanoma) - a Phase 2 Clinical Trial
- ClinicalTrials.gov ID
- NCT07112170
- Acronym / sponsor ID
- CURB-Melanoma / 25-5162
- Keywords
- stereotactic body radiation therapy (SBRT), Melanoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- 24 Jul 2027 (estimated)
- Study completion
- 24 Jul 2028 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Radiation: Stereotactic Body Radiation Therapy (SBRT)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- >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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT)SBRT will be delivered as per institutional standard. | Radiation | Single Arm |
Primary outcome
Progression-Free Survival (PFS) assessed by radiological imaging using RECIST v1.1 criteria
Time frame: From enrollment up to 24 months
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.
6 secondary outcomes
Overall Survival (OS) measured from date of enrollment to death from any cause
Time frame: Enrollment up to 24 months
Time on Current Systemic Therapy After Initial Oligoprogression
Time frame: From enrollment up to 24 months
Out-of-field response assessed by radiological imaging (CT, PET-CT, or MRI)
Time frame: From enrollment up to 24 months.
Reporting acute and late toxicities of SBRT
Time frame: Enrollment up to 24 months
Participant-reported adverse events measured using PRO-CTCAE questionnaire
Time frame: From baseline through follow-up (up to 24 months)
Participant-reported quality of life measured using EORTC QLQ-C30 questionnaire
Time frame: From baseline through follow-up (up to 24 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Derived from this study: PubMed 42518820Icht 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Body Radiation Therapy (SBRT) in people with Metastatic Melanoma and OligoProgressive Metastatic Disease, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jillian C Tsai, MD (416-946-4501 ext. 4866, jillian.tsai@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) assessed by radiological imaging using RECIST v1.1 criteria (time frame: From enrollment up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07112170, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.