OncoMatch

OncoMatch/Clinical Trials/NCT03563729

Melanoma Metastasized to the Brain and Steroids

Is NCT03563729 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments for malignant melanoma.

Phase 2RecruitingInge Marie SvaneNCT03563729Data as of Jun 2026Location: Denmark

Treatment: Pembrolizumab · Ipilimumab · Nivolumab · Encorafenib · Binimetinib · Dabrafenib · TrametinibThis 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).

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Extracted eligibility criteria

Treatments studied

Immunotherapy

PembrolizumabIpilimumabNivolumab

Targeted therapy

EncorafenibBinimetinibDabrafenibTrametinib

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.

Frequently asked questions

Is NCT03563729 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior anti-PD-1/PD-L1/PD-L2/CTLA-4 antibody, BRAF inhibitor, MEK inhibitor disqualifies patients from enrollment.

Does this trial require BRAF?

Yes, BRAF mutation is a required biomarker for enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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