OncoMatch/Clinical Trials/NCT03563729
Melanoma Metastasized to the Brain and Steroids
Is NCT03563729 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for malignant melanoma.
Treatment: Pembrolizumab · Ipilimumab · Nivolumab · Encorafenib · Binimetinib · Dabrafenib · Trametinib — This clinical trial is to clarify whether treatment with a checkpoint inhibitor alone (pembrolizumab) or two in combination (ipilimumab and nivolumab), results in clinical benefit for MM patients with brain metastases and in need of steroid treatment. Patients will be treated in four arms depending on steroid dose level at inclusion (\> 10 \< 25 mg prednisolone or \> 25 mg prednisolone) and treatment (pembrolizumab alone or the combination of ipilimumab and nivolumab).
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Biomarker criteria
Required: BRAF mutation
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anti-PD-1/PD-L1/PD-L2/CTLA-4 antibody
Exception: adjuvant setting allowed if completed >6 months before enrolment
Prior treatment with anti-PD-1/PD-L1/PD-L2/CTLA-4 antibodies in the metastatic setting; Prior systemic treatment with anti-PD-1/PD-L1/PD-L2/CTLA-4 antibodies in the adjuvant setting, unless completed more than 6 months before enrolment in this study
Cannot have received: BRAF inhibitor
For arm E specifically: Prior treatment with BRAF/MEK inhibitors.
Cannot have received: MEK inhibitor
For arm E specifically: Prior treatment with BRAF/MEK inhibitors.
Lab requirements
Blood counts
Kidney function
Liver function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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