Spots Global Cancer Trial Database for STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS

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Trial Identification

Brief Title: STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS

Official Title: 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)

Study ID: NCT04878432

Conditions

Myelodysplastic Syndrome (MDS)

Interventions

MBG453

Azacitidine

Decitabine

INQOVI (oral decitabine)

Study Description

Brief Summary: Main objective of this study is to describe and evaluate safety and efficacy of MBG453 (sabatolimab) in combination with FDA approved HMAs of investigator's choice (IV Decitabine or Azacitidine /SC Azacitidine /Oral Decitabine (cedazuridine combination (INQOVI))

Detailed Description: This is a single-arm, non- randomized, open label, phase II multi-center study of intravenous MBG453 (sabatolimab) added to FDA approved Hypomethylating agents of investigator's choice (IV/SC/ Oral) in adult participants with intermediate, high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R criteria. There are three separate periods of this study: 1. Screening period (signing of written informed consent through Day 1); 2. Core phase for 12 months; 3. Extension phase for efficacy and/or survival status (up to 12 months after core phase) 4. Post treatment safety follow-up monitoring for adverse events (AEs) for 30 days following the last dose of azacitidine or decitabine or INQOVI (oral decitabine), or 150 days following the last dose of MBG453 (sabatolimab), whichever is later).