Actively Recruiting
Stereotactic Ablative Radiotherapy (XRT) and Immunotherapy for Oligometastatic Extracranial Melanoma
Led by Melanoma Institute Australia · Updated on 2026-05-07
129
Participants Needed
5
Research Sites
421 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this research is to evaluate the addition of radiotherapy to the standard immunotherapy drugs that are given to patients with advanced or metastatic melanoma that has spread to other parts of the body. Radiotherapy uses x-rays to target and kill melanoma cells and immunotherapy works by activating the body's own immune system to seek out and fight melanoma cells. Both of these treatments are commonly given to patients with advanced melanoma and other cancers. Both treatments are usually given separately but can also be given together. The aim of this research is to find out if giving radiotherapy and immunotherapy together is better than giving immunotherapy alone. The type of radiotherapy to be used in this project is known as 'stereotactic' body radiotherapy or SBRT (also known as stereotactic body ablative radiotherapy, SABR). SBRT targets the radiation very precisely at the metastatic deposits in the body. This method protects the healthy areas near the melanoma. SBRT works by delivering a high dose of radiation precisely to the areas of melanoma which causes the melanoma cells to break apart and eventually die. SBRT is given in 'fractions' which means the high dose is given in small measures over several days, depending on the number and size of metastases.
CONDITIONS
Official Title
Stereotactic Ablative Radiotherapy (XRT) and Immunotherapy for Oligometastatic Extracranial Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female or male patients aged 18 or older
- Willing to provide signed informed consent
- Life expectancy greater than 6 months
- First diagnosis of AJCC Stage IV cutaneous, acral, or unknown primary melanoma with 1 to 5 extracranial metastases seen on CT and PET-CT, considered unresectable
- Up to 4 in-transit metastases allowed in addition to distant metastases, all counted within maximum lesion number
- Prior surgery for symptoms allowed if total remaining extracranial metastases are 5 or fewer, with no more than one excised metastatic lesion
- At least one measurable metastasis per RECIST version 1.1
- No brain metastases on MRI or CT if MRI contraindicated
- All lesions can be treated with minimum SBRT biologically effective dose of 48Gy
- Able to tolerate immunotherapy as determined by medical oncologist
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2
- Women of childbearing potential must have negative pregnancy test within 7 days prior to randomization
You will not qualify if you...
- Ocular or mucosal melanoma
- Serious or unstable medical comorbidities or conditions interfering with safety, consent, or compliance
- Immediate need for radiotherapy (e.g., spinal cord compression, rapidly progressing symptomatic disease)
- Prior radiotherapy for Stage IV disease (adjuvant radiotherapy for Stage I-III allowed but not included in baseline lesions)
- Inability to treat all disease sites with SBRT as judged by radiation oncologist
- Prior systemic drug therapy for melanoma except in neoadjuvant or adjuvant setting for Stage I-III
- Contraindications to planned immunotherapy regimen
- Moderate to severe liver dysfunction if liver metastases present
- History or concurrent other malignancy unless disease-free for at least 1 year and low recurrence risk
- Pregnant or breastfeeding females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
2
Melanoma Institute Australia
Wollstonecraft, New South Wales, Australia, 2065
Actively Recruiting
3
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
4
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Actively Recruiting
5
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
Research Team
M
Monica Osorio
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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