Recruiting
Phase 2

SBRT & Immunotherapy

Sponsor:

Melanoma Institute Australia

Code:

NCT06767306

Conditions

Melanoma Metastatic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stereotactic Body Radiotherapy (extracranial) concurrent with Immunotherapy

Immunotherapy alone

Study Details

Brief summary:

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

Melanoma Metastatic

Study ID

NCT06767306

Start date

Mar 6, 2025

Status verified date

Apr, 2026

Completion date

Apr 1, 2033

Anticipated

Primary completion date

Apr 1, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Female or male patients, age 18 or older
  • Willing to provide signed informed consent
  • Life expectancy > 6 months
  • First presentation of AJCC Stage IV (any N, M1a, M1b, M1c), histologically confirmed cutaneous, acral or unknown primary melanoma with one to five extracranial metastases detected on CT and whole body PET-CT, and considered unresectable
  • A primary lesion and / or up to 4 in-transit metastases(is) (ITM) in addition to distant metastases(is) are permitted and will be counted in the maximum number of permitted baseline lesions
  • Prior surgery for symptomatic disease (e.g. small bowel obstruction) for this first presentation of Stage IV melanoma is permitted, provided the total number of remaining extracranial metastases is ≤ 5 (NOT including the resected lesion). No more than one excised metastatic lesion is permitted
  • At least one metastasis should be measurable as a target lesion per RECIST version 1.1
  • No evidence of cerebral metastases on MRI brain (CT brain is acceptable if there is contraindication to MRI)
  • All lesions can be treated with a minimum SBRT biologically effective dose (BED) of 48Gy
  • Able to tolerate treatment with immunotherapy as determined by the medical oncologist
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days of randomisation

Exclusion Criteria:

  • Ocular or mucosal melanoma
  • Serious or unstable medical co-morbidities or other conditions that could interfere with the patient's safety, consent, or compliance
  • Patients for whom there is a definite and immediate indication for radiotherapy (e.g., spinal cord compression, rapidly progressing disease associated with clinical signs and symptoms)
  • Prior radiotherapy for Stage IV disease (prior adjuvant radiotherapy to primary site or nodal field (Stage I-III disease) is permitted, however adjuvant-treated sites must not be included in the baseline lesions
  • Inability to treat all disease sites with SBRT as determined by radiation oncologist
  • Prior systemic drug therapy for melanoma, unless given in the neoadjuvant or adjuvant setting for Stage I-III disease
  • Any contraindication to the planned standard of care immunotherapy regimen per regulatory approved product information
  • For patients with liver metastases - moderate/severe liver dysfunction
  • A known history of another malignancy or concurrent malignancy unless the patient is disease-free for a minimum of 1 year, is completely treated and is at low risk of recurrence
  • Pregnant or breastfeeding females

Study Design

Enrollment

129 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: Concurrent stereotactic body radiotherapy + Immune checkpoint inhibitor(s)

Concurrent stereotactic body radiotherapy (SBRT) with standard of care immune checkpoint inhibitor(s) (ICI).

Patients will receive a minimum SBRT biologically effective dose (BED) of 48Gy10 to all sites of metastatic disease between cycle 1 and cycle 3 of immunotherapy. The interval between cycles 1 and 3 will depend on the prescribed immunotherapy regimen that is standard of care at each participating site.

Standard of care 1st line immunotherapy, as decided by the treating clinician and in accordance with the current listing on the Australian Register of Therapeutic Goods (ARTG) or applicable international regulatory agency will be administered concurrently

active comparator: Arm B: Immune checkpoint inhibitor(s)

Immunotherapy alone

Standard of care 1st line immunotherapy, as decided by the treating clinician and in accordance with the current listing on the Australian Register of Therapeutic Goods (ARTG) or applicable international regulatory agency will be administered alone.

Interventions

Stereotactic Body Radiotherapy (extracranial) concurrent with Immunotherapy

Radiotherapy A minimum SBRT biologically effective dose (BED) of 48Gy10 to all sites of extracranial metastatic disease should be administered between cycle 1 and cycle 3 of standard of care immunotherapy.

Immunotherapy All patients will receive standard of care 1st line immunotherapy as decided by the treating clinician and in accordance with the current listing on the Australian Register of Therapeutic Goods (ARTG) or applicable international regulatory agency.

Other Names:

Immune checkpoint inhibitor Standard of care immunotherapy First line treatment

Immunotherapy alone

All patients will receive standard of care 1st line immunotherapy as decided by the treating clinician and in accordance with the current listing on the Australian Register of Therapeutic Goods (ARTG) or applicable international regulatory agency.

Primary outcome measure

  • Overall survival [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Monica Osorio

+61 2 9911 7296monica.osorio@melanoma.org.au

Locations

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Principal Investigator:

Philip Wong

More Information

Sponsor

Melanoma Institute Australia

Last update posted

May 7, 2026

Last verified

Apr, 2026

Keywords

  • SABR
  • stereotactic body radiotherapy
  • Stereotactic Ablative Body Radiotherapy
  • SABRT
  • Immunotherapy
  • Immune Checkpoint Inhibitors
  • Oligometastases
  • Extracranial
  • Quality of life
  • Biomarkers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Melanoma Institute Australia on 2026-05-07.