ClinicalTrials.gov record
Terminated Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT04878432

Public ClinicalTrials.gov record NCT04878432. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 20, 2026, 2:14 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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 identification

NCT ID
NCT04878432
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 2
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
39 participants

Conditions and interventions

Interventions

  • Azacitidine Drug
  • Decitabine Drug
  • INQOVI (oral decitabine) Drug
  • MBG453 Drug

Drug

Eligibility (public fields only)

Age range
18 Years to 99 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 16, 2022
Primary completion
Oct 25, 2023
Completion
Aug 31, 2024
Last update posted
Oct 15, 2025

2022 – 2024

United States locations

U.S. sites
15
U.S. states
10
U.S. cities
13
Facility City State ZIP Site status
Mayo Clinic Arizona Phoenix Arizona 85054
Arizona Oncology Associates Tucson Arizona 85745
SCRI-Colorado Blood Cancer Institute Denver Colorado 80218
Yale University School Of Medicine New Haven Connecticut 06520
Advent Health Orlando Orlando Florida 32803
Uni of Massachusetts Medical Center Worcester Massachusetts 01655
University Of Michigan Ann Arbor Michigan 48109
Karmanos Cancer Institute Detroit Michigan 48201
Tisch Hospital NYU Langone New York New York 10016
Mount Sinai Medical Center New York New York 10029-6574
Duke Cancer Institute Durham North Carolina 27710
University Hospitals Of Cleveland Cleveland Ohio 44106
Cleveland Clinic Cleveland Ohio 44195
Uni Of TX MD Anderson Cancer Cntr Houston Texas 77030
Texas Oncology San Antonio USO San Antonio Texas 78240

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04878432, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 15, 2025 · Synced May 20, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04878432 live on ClinicalTrials.gov.

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