At a glance
ClinicalIndex Comparison Record- ✓Female or male patients, ≥18 years of age
- ✓AJCC Stage IV histologically confirmed cutaneous, acral or mucosal unresectable melanoma or unknown primary melanoma
- ✓At least 1 brain metastasis ≥5mm and ≤40mm, measurable per RECIST v1.1
- ✓BRAF mutation status must be available prior to randomisation
- ✕Brain metastasis >40mm
- ✕Evidence of leptomeningeal disease
- ✕History of or current ocular melanoma
- ✕Neurological symptoms from brain metastases at baseline
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Open Label, Randomised, Controlled Trial of Ipilimumab and Nivolumab With Concurrent Intracranial Stereotactic Radiotherapy Versus Ipilimumab and Nivolumab Alone in Patients With Melanoma Brain Metastases.
In Brief
A Phase 2 clinical trial evaluating Ipilimumab, Nivolumab, and 2 other interventions for Melanoma Stage Iv. Currently recruiting, targeting 218 participants across 9 sites in 2 countries.
Signals
Detailed Summary
This is a phase II, open label, randomised trial of ipilimumab and nivolumab with concurrent intracranial stereotactic radiotherapy versus ipilimumab and nivolumab alone in patients with asymptomatic, untreated melanoma brain metastases.
Study Details
Timeline
Interventions
Ipilimumab 3mg per kg every 3 weeks for 4 doses
Nivolumab 1mg/kg every 3 weeks for 4 doses, then 480mg every 4 weeks.
The first dose of immunotherapy Must be given prior to the start of radiotherapy. One fraction at between 16 to 22 Gy or 24 to 30 Gy hypofractionated for larger lesions.
Any form of salvage therapy (surgery or radiotherapy) for intracranial disease progression, further disease control at any site, symptom control or treatment of cerebral haemorrhage or cerebral radionecrosis.