At a glance
ClinicalIndex Comparison Record- ✓Histologically and pathologically confirmed melanoma metastasized to brain
- ✓BRAF-V600 mutant melanoma documented by CLIA-certified laboratory
- ✓MRI of brain within 28 days prior to registration
- ✓At least one measurable brain metastasis ≥0.5 cm (modified RECIST 1.1) that has not been irradiated or progressed after prior radiation
- ✕Uveal primary melanoma not eligible
- ✕Prior systemic therapy for metastatic disease not permitted
- ✕Prior radiation therapy within 7 days of randomization
- ✕Planning additional systemic anti-tumor therapy for melanoma while on protocol
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Phase 2 Trial of Encorafenib + Binimetinib + Nivolumab vs Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases
In Brief
A Phase 2 clinical trial evaluating Binimetinib, Encorafenib, and 2 other interventions for Acral Lentiginous Melanoma and 6 related conditions. Currently recruiting, targeting 112 participants across 331 sites.
Signals
Detailed Summary
This phase II trial compares the effect of encorafenib, binimetinib, and nivolumab versus ipilimumab and nivolumab in treating patients with BRAF- V600 mutant melanoma that has spread to the brain (brain metastases). Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Ipilimumab and nivolumab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. This trial aims to find out which approach is more effective in shrinking and controlling brain metastases from melanoma.
Study Details
Timeline
Interventions
Given PO
Given PO
Given IV
Given IV