RecruitingPhase 2NCT06767306

Stereotactic Ablative Radiotherapy (XRT) and Immunotherapy for Oligometastatic Extracranial Melanoma

A Phase II, Multicentre, Non-Comparative, Randomised Controlled Trial of Stereotactic Ablative Body Radiotherapy and Immunotherapy Versus Immunotherapy Alone in Patients With Treatment Naïve Oligometastatic Extracranial Melanoma

Sponsor

Melanoma Institute Australia

Enrollment

129 participants

Start Date

Mar 6, 2025

Study Type

INTERVENTIONAL

Conditions

Melanoma Metastatic

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether combining stereotactic ablative radiotherapy (very precise, high-dose radiation) with immunotherapy (pembrolizumab or nivolumab) can effectively treat patients with oligometastatic melanoma — meaning melanoma that has spread to only a few spots in the body (1-5 metastases). **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of stage IV melanoma (cutaneous, acral, or unknown primary) - You have 1 to 5 metastases outside the brain that are unresectable - This is your first time having stage IV disease - You have a life expectancy greater than 6 months - You are willing to receive both radiation and immunotherapy **You may NOT be eligible if...** - You have more than 5 active metastatic lesions - You have had prior immunotherapy for melanoma (in the metastatic setting) - You have active autoimmune disease requiring immunosuppressive treatment - You have active brain metastases requiring immediate treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERStereotactic 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

DRUGImmunotherapy 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.