Single-arm open label phase II study of MBG453 (sabatolimab) added to FDA approved Hypomethylating agents of investigator s choice (IV/SC/Oral) for patients with intermediate high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R criteria (US multi-center) (STIMULUS MDS-US)
Brief description of study
The purpose of the study is to describe and evaluate safety and efficacy of MBG453 (sabatolimab) in combination with FDA approved Hypomethylating agents (HMA). We want to know the progression free survival and overall survival rates. The study drug MBG453 is investigational, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent in the current trial.
Clinical Study Identifier: s20-01773
ClinicalTrials.gov Identifier: NCT04878432
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