Bevacizumab and ICIs + hSRT in Symptomatic Melanoma Brain Metastases
Single arm phase I/II trial to evaluate the safety and efficacy of the combination of bevacizumab, with ipilimumab plus nivolumab, and hypofractionated stereotactic radiotherapy (hSRT) in patients with symptomatic melanoma brain metastases (MBM).
| Condition(s) | Melanoma Brain Metastases |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | Single arm phase I/II trial to evaluate the safety and efficacy of the combination of bevacizumab, with ipilimumab plus nivolumab, and hypofractionated stereotactic radiotherapy (hSRT) in patients with symptomatic melanoma brain metastases (MBM). |
| Who can participate | Inclusion Criteria: * 1\. Histologically (or cytologically) proven metastatic melanoma, with radiologically confirmed brain metastases. * 2\. Symptomatic from brain metastases at the time of study enrolment, or brain metastases that requires corticosteroids for the management of neurological symptoms. * 3\. Intracranial lesions amenable to hypofractionated stereotactic radiotherapy. These are defined as all intracranial melanoma lesions greater or equal to 5 mm in diameter, all intracranial lesions that are causing symptoms, and all intracranial lesions located in the eloquent areas of the brain. * 4\. World Health Organisation (WHO) performance status of 0 - 2 * 5\. At least one brain metastasis has to be symptomatic. * 6\. Laboratory tests required: Haemoglobin (Hb) ≥ 9.0 g/dL Absolute n |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Melanoma and Skin Cancer Trials Limited |
| Locations | Melbourne, Victoria, Australia |
| Start date | 2025-05-31 |
| NCT ID | NCT06163820 |
| Official listing | https://clinicaltrials.gov/study/NCT06163820 |