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

Myelodysplastic Syndrome (MDS) Clinical Trial

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)

Status Active, not recruiting

Clinical Trial 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))

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Myelodysplastic Syndrome (MDS)
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

• NCT number: NCT04878432
• Study type: Interventional
• Source: Novartis
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 17, 2022
• Completion date: June 14, 2024