drugset / Trial / NCT04878432
STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS
NaSingle-groupOpen-labelTreatment
Summary
The main objective of this study was to assess the safety profile of MBG453 (sabatolimab) in combination with FDA approved hypomethylating agents (HMAs) of investigator's choice (IV Decitabine or Azacitidine /SC Azacitidine /Oral Decitabine (cedazuridine combination (INQOVI))).
Timeline
- Start
- 2022-03-17
- Primary completion
- 2023-10-26
- Completion
- 2024-09-01
Outcome
Outcome not reported
Stopped: “Lack of efficacy in the program as demonstrated in the earlier CMBG453B12301 (STIMULUS MDS-2) study.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sabatolimab | Monoclonal antibody | — | Intravenous |
| Background | Azacitidine | Other / unclassified | — | Subcutaneous |
| Background | Decitabine | Small molecule | — | Intravenous |
| Background | INQOVI | Unknown | — | Oral |