Clinical trial · no report yet · Phase 3
STIMULUS-MDS2
Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)
- NCT04266301 ↗
- Terminated
- Novartis Pharmaceuticals
- Standard
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Preliminary discovery
Commentary in our index that names this trial so far
Podcasts, YouTube videos and X posts we have indexed. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build.
| Channel | Found | |
|---|---|---|
| X threads | 10 | |
| Podcasts | 3 | |
| YouTube | 2 |
The trial
ClinicalTrials.gov- Official title
- A Randomized, Double-blind, Placebo-controlled Phase III Multi-center Study of Azacitidine With or Without MBG453 for the Treatment of Patients With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)
- Phase
- Phase 3
- Status
- Terminated
- Conditions
- Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic
- Interventions
- Sabatolimab; Azacitidine; Placebo
- Arms
- Sabatolimab (MBG453) + Azacitidine · Experimental
- Placebo + Azacitidine · Placebo comparator
- Enrollment
- 530
- Primary outcomes
- Overall Survival (OS) (Primary Efficacy Results)
- Overall Survival (OS) (Final Efficacy Results)
- Sponsor
- Novartis Pharmaceuticals
- Start
- Jun 8, 2020
- Primary completion
- Oct 2, 2024
- Results posted
- Yes
- Registry record
- NCT04266301 · updated Jan 13, 2026
Publications
linked from the registry- Zeidan AM, Giagounidis A, Sekeres MA, Xiao Z, Sanz GF, Hoef MV, Ma F, Hertle S, Santini V. STIMULUS-MDS2 design and rationale: a phase III trial with the anti-TIM-3 sabatolimab (MBG453) + azacitidine in higher risk MDS and CMML-2. Future Oncol. 2023 Mar;19(9):631-642. doi: 10.2217/fon-2022-1237. Epub 2023 Apr 21. PubMed 37083373