Clinical Trial

Melanoma Metastasized to the Brain and Steroids

Study acronym: MEMBRAINS
Recruiting Phase 2
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Record status
This record was last updated July 13, 2023 (before its estimated June 1, 2024 completion). Its status may not reflect the trial's current state.
Summary
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).
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2018-06-19; most recent amendment 2023-07-12.
Trial Details
NCT Number NCT03563729
Lead Sponsor Inge Marie Svane
Conditions Malignant Melanoma
Enrollment 80 participants
Start Date 2018-06-06
Primary Completion 2024-06-01 (estimated)
Study Completion 2028-06-06 (estimated)
Updated on ClinicalTrials.gov 2023-07-13