Stimulus MDS-US

Trial in Progress: Evaluating Sabatolimab in Combination with Hypomethylating Agents (HMAs) in Patients with Intermediate-, High-, or Very High-Risk Myelodysplastic Syndrome (MDS)

Clinical Trial: STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS 
ClinicalTrials.gov Identifier: NCT04878432

Patients with intermediate-, high-, or very-high-risk myelodysplastic syndrome (I/H/vHR-MDS) need durable treatment options with favorable tolerability. Sabatolimab (MBG453) is a novel immunotherapy drug targeting TIM-3, an immuno-myeloid regulator expressed on immune and leukemic stem cells but not on normal healthy stem cells. Patients with higher-risk MDS experience poor outcomes and have limited treatment options. Hypomethylating agents, HMAs, are approved for the management of higher-risk MDS. However, 50% of HMA-treated patients experience primary failure, and most responders progress within 2 years. New therapies that provide improved, durable outcomes with favorable safety profiles are needed for these patients.

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

What is this study evaluating?

This study intends to evaluate the complete remission (CR) rate, the progression free survival in participants with intermediate, high or very high risk MDS, number of treatments, the overall survival and leukemia free survival, and the emergent adverse events and serious adverse events.

What is the treatment or intervention?

The STIMULUS MDS-US study is a nonrandomized, single-arm, open-label, phase II study evaluating the safety and efficacy of sabatolimab in combination with FDA-approved HMAs of the investigator's choice in patients with MDS in the United States. A 12-month extension phase will continue investigating safety and efficacy after 24 months of treatment. 

What results will this study look at?

Patients will receive IV sabatolimab 800 mg on day 8 (D8; or once between D5-8 to coincide with partner HMA administration) of each 28-day cycle for 24 months plus the investigator's choice of the following HMAs: oral decitabine (Inqovi®, decitabine 35 mg and cedazuridine 100 mg, D1-5); IV decitabine (20 mg/m2, D1-5); or IV or subcutaneous azacitidine (75 mg/m2, D1-7 or D1-5+8-9). 

Primary end points are incidence and severity of adverse events and serious adverse effects. Secondary endpoints are complete remission (CR) rate, progression-free survival, overall survival, leukemia-free survival, percentage of patients with CR, marrow CR and/or partial remission, duration of CR, time to CR, and percentage of patients with improvement in red blood cell/platelet transfusion independence.

Who is this study for?

Eligible patients are aged ≥18 years and have treatment-naive, higher-risk MDS (IPSS-R intermediate- or high/very high-risk) not suitable for intensive chemotherapy or hematopoietic stem cell transplant.

Currently in phase 2, recruiting. For more information about the inclusion/exclusion criteria, click here.

Contact information for the study: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com 

STUDY SITES

The study is open at 23 locations recruiting: Ironwood Cancer and Research Centers, Arizona Oncology Associates Arizona Oncology Assoc PC, Mayo Clinic Arizona, Arizona Oncology Associates, Arizona Oncology Associates, SCRI- Colorado Blood Cancer Institute, Yale University School of Medicine, AdventHealth Orlando, Illinois Cancer Care P.C. IL Cancer Specialists, Illinois Cancer Care P.C., University of Massachusetts Medical Center, University of Michigan, Karmanos Cancer Institute Div.of Hematology/Oncology, Tisch Hospital NYU Langone, Mount Sinai Medical Center, Messino Cancer Centers, Duke Cancer Institute, University Hospitals of Cleveland, Cleveland Clinic, Alliance Cancer Specialists USO, Texas Oncology-Baylor USO, University of Texas MD Anderson Cancer Center, Texas Oncology San Antonio USO.

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