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NotablePhase: Not applicable to Phase 2Study sites: 1 to 4 · Interventions: Immunotherapy alone (Drug), Stereotactic Body Radiotherapy (extracranial) concurrent with immunotherapy (Radiation) to Immunotherapy alone (Drug), Stereotactic Body Radiotherapy (extracranial) concurrent with Immunotherapy (Other) · Secondary endpoints: details revised at 1 of 8 entriesv4Show 3 more changesShow less
Study sites: 1 to 4
Interventions: Immunotherapy alone (Drug), Stereotactic Body Radiotherapy (extracranial) concurrent with immunotherapy (Radiation) to Immunotherapy alone (Drug), Stereotactic Body Radiotherapy (extracranial) concurrent with Immunotherapy (Other)
Secondary endpoints: details revised at 1 of 8 entries
MinorSecondary endpoints: details revised at 1 of 8 entriesv3
NotableTrial status: Not Yet Recruiting to RecruitingStart date changed from estimate of Apr 1, 2025 to Mar 6, 2025 · Site details revisedv2Show 2 more changesShow less
Start date changed from estimate of Apr 1, 2025 to Mar 6, 2025
Site details revised
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.