At a glance
ClinicalIndex Comparison Record- ✓Age 18 or older
- ✓AJCC Stage IV melanoma with 1-5 extracranial metastases, unresectable
- ✓At least one measurable metastasis per RECIST 1.1
- ✓No brain metastases on MRI brain
- ✕Ocular or mucosal melanoma
- ✕Serious or unstable medical co-morbidities interfering with safety, consent, or compliance
- ✕Immediate indication for radiotherapy (e.g., spinal cord compression, rapidly progressing disease)
- ✕Prior radiotherapy for Stage IV disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Stereotactic Body Radiotherapy (extracranial) concurrent with Immunotherapy and Immunotherapy alone for Melanoma Metastatic. Currently recruiting, targeting 129 participants across 5 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
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
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.