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

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)

ClinicalTrials.gov Identifier: NCT04878432

Novartis Reference Number: CMBG453B1US01

Last Update: Apr 25, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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))

Condition 
Myelodysplastic Syndrome (MDS)
Phase 
Phase 2
Overall status 
Recruiting
Start date 
Mar 17, 2022
Completion date 
Mar 31, 2025
Gender 
All
Age(s)
18 Years - 99 Years (Adult, Older Adult)

Interventions

Drug
MBG453
Solution for intravenous infusion
Drug
Azacitidine
Solution for subcutaneous injection or intravenous infusion
Drug
Decitabine
Solution for intravenous infusion
Drug
INQOVI (oral decitabine)
Tablet for oral administration
Drug
MBG453
Solution for intravenous infusion
Drug
Azacitidine
Solution for subcutaneous injection or intravenous infusion
Drug
Decitabine
Solution for intravenous infusion
Drug
INQOVI (oral decitabine)
Tablet for oral administration
Drug
MBG453
Solution for intravenous infusion
Drug
Azacitidine
Solution for subcutaneous injection or intravenous infusion
Drug
Decitabine
Solution for intravenous infusion
Drug
INQOVI (oral decitabine)
Tablet for oral administration

Eligibility Criteria

Inclusion Criteria:

Signed informed consent must be obtained prior to participation in the study.
Age ≥ 18 years at the date of signing the informed consent form (ICF).
Morphologically confirmed diagnosis of a myelodysplastic syndrome (MDS) primary or secondary based on 2016 WHO classification (Arber et al 2016) by investigator assessment with one of the following Prognostic Risk Categories, based on the International Prognostic Scoring System (IPSS-R). Note: MDS diagnosis history will be recorded in the CRF:
Very high (> 6 points)
High (> 4.5 - ≤ 6 points)
Intermediate (> 3 - ≤ 4.5 points)
Not suitable at the time of screening for immediate myeloablative/ chemotherapy or hematopoietic stem cell transplantation based on investigator assessment of age, comorbidities, local guidelines, institutional practice (any or all of these).
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
AST and ALT ≤ 3 × upper limit of normal (ULN).
Total bilirubin ≤ 2 × ULN (except in the setting of isolated Gilbert syndrome).
Estimated Glomerular Filtration Rate (eGFR) ≥ 30 mL/min/1.73m2 (estimation based on Modification of Diet in Renal Disease (MDRD) formula, by local laboratory).
Patient is able to communicate with the investigator and has the ability to comply with the requirements of the study procedures.

Exclusion Criteria:

Prior exposure to TIM-3 directed therapy at any time. Prior therapy with immune checkpoint inhibitors (e.g. anti-CTLA4, anti-PD-1, anti-PD-L1, or anti-PD-L2), cancer vaccines are allowed only if the last dose of the drug was administered more than 4 months prior to enrollment.
Previous treatment for intermediate, high or very high risk myelodysplastic syndromes (based on IPSS-R) with chemotherapy or other antineoplastic agents including lenalidomide and hypomethylating agent (HMAs) such as decitabine or azacitidine or INQOVI (oral decitabine) (patients who had up to 1 cycle of HMAs can be included). However, previous treatment with hydroxyurea is permitted.
Diagnosis of acute myeloid leukemia (AML) including acute promyelocytic leukemia and extra-medullary acute myeloid leukemia based on WHO 2016 classification (Arber et al 2016).
Diagnosis of Chronic myelomonocytic leukemia (CMML), or primary or secondary myelofibrosis based on 2016 WHO classification (Arber et al 2016).
History of organ transplant or allogenic hematopoietic stem cell transplant

Participants with prior malignancy, except:

Participants with history of lower risk MDS treated by supportive care (e.g. growth factors, TGF-beta agents) or untreated are eligible
Participants with history of lower risk MDS who were treated adequately with lenalidomide and then failed are eligible
Participants with history of adequately treated malignancy for which no anticancer systemic therapy (namely chemotherapy, radiotherapy or surgery) is ongoing or required during the course of the study. Participants who are receiving adjuvant therapy such as hormone therapy are eligible.
Participants with Myelodysplastic syndrome (MDS) based on 2016 WHO classification (Arber et al 2016) with revised International Prognostic Scoring System (IPSS-R) ≤ 3

Study Locations

United States
Ironwood Cancer and Research Centers
Recruiting
Chandler, 85224 - Arizona
Contact: (480-855-2225) Mikhail I Shtivelband
United States
Arizona Oncology Associates Arizona Oncology Assoc PC
Recruiting
Phoenix, 85016 - Arizona
Contact: (520-877-9096) Sudhir Manda
United States
Mayo Clinic Arizona
Recruiting
Phoenix, 85054 - Arizona
Contact: (480-342-2545) Cecilia Arana Yi
United States
Arizona Oncology Associates
Recruiting
Tucson, 85745 - Arizona
Contact: Sudhir Manda
United States
Arizona Oncology Associates
Recruiting
Tucson, 85745 - Arizona
Contact: Manda Sudhir
United States
SCRI- Colorado Blood Cancer Institute
Recruiting
Denver, 80218 - Colorado
Contact: (720-754-4800) Alireza Eghtedar
United States
Illinois Cancer Care P.C. IL Cancer Specialists
Recruiting
Peoria, 61615-7828 - Illinois
Contact: (847-827-0319) Leonard Klein
United States
Illinois Cancer Care P.C.
Recruiting
Peoria, 61615-7828 - Illinois
Contact: Leonard Klein
United States
University of Massachusetts Medical Center
Recruiting
Worcester, 01655 - Massachusetts
Contact: (508-856-1767) Jonathan Gerber
United States
University of Michigan
Recruiting
Ann Arbor, 48109 - Michigan
Contact: Patrick W Burke
United States
Karmanos Cancer Institute Div.of Hematology/Oncology
Recruiting
Detroit, 48201 - Michigan
Contact: (313-576-8730) Jay Yang
United States
Tisch Hospital NYU Langone
Recruiting
New York, 10016 - New York
Contact: Mohammad Maher Abdul Hay
United States
Messino Cancer Centers
Recruiting
Asheville, 28806 - North Carolina
Contact: Christopher Chay
United States
University Hospitals of Cleveland
Recruiting
Cleveland, 44106 - Ohio
Contact: (*Various See Departments*) Benjamin Tomlinson
United States
Alliance Cancer Specialists USO
Recruiting
Horsham, 19044 - Pennsylvania
Contact: Joseph Potz
United States
Texas Oncology-Baylor USO
Recruiting
Dallas, 75246 - Texas
Contact: Moshe Levy
United States
University of Texas MD Anderson Cancer Center
Recruiting
Houston, 77030 - Texas
Contact: (713-792-2921) Guillermo Garcia-Manero
United States
Texas Oncology San Antonio USO
Recruiting
San Antonio, 78240 - Texas
Contact: Roger Lyons
United States
Ironwood Cancer and Research Centers
Recruiting
Chandler, 85224 - Arizona
Contact: (480-855-2225) Mikhail I Shtivelband
United States
Arizona Oncology Associates Arizona Oncology Assoc PC
Recruiting
Phoenix, 85016 - Arizona
Contact: (520-877-9096) Sudhir Manda
United States
Mayo Clinic Arizona
Recruiting
Phoenix, 85054 - Arizona
Contact: (480-342-2545) Cecilia Arana Yi
United States
Arizona Oncology Associates
Recruiting
Tucson, 85745 - Arizona
Contact: Sudhir Manda
United States
Arizona Oncology Associates
Recruiting
Tucson, 85745 - Arizona
Contact: Manda Sudhir
United States
SCRI- Colorado Blood Cancer Institute
Recruiting
Denver, 80218 - Colorado
Contact: (720-754-4800) Alireza Eghtedar
United States
Illinois Cancer Care P.C. IL Cancer Specialists
Recruiting
Peoria, 61615-7828 - Illinois
Contact: (847-827-0319) Leonard Klein
United States
Illinois Cancer Care P.C.
Recruiting
Peoria, 61615-7828 - Illinois
Contact: Leonard Klein
United States
University of Massachusetts Medical Center
Recruiting
Worcester, 01655 - Massachusetts
Contact: (508-856-1767) Jonathan Gerber
United States
University of Michigan
Recruiting
Ann Arbor, 48109 - Michigan
Contact: Patrick W Burke
United States
Karmanos Cancer Institute Div.of Hematology/Oncology
Recruiting
Detroit, 48201 - Michigan
Contact: (313-576-8730) Jay Yang
United States
Tisch Hospital NYU Langone
Recruiting
New York, 10016 - New York
Contact: Mohammad Maher Abdul Hay
United States
Messino Cancer Centers
Recruiting
Asheville, 28806 - North Carolina
Contact: Christopher Chay
United States
University Hospitals of Cleveland
Recruiting
Cleveland, 44106 - Ohio
Contact: (*Various See Departments*) Benjamin Tomlinson
United States
Alliance Cancer Specialists USO
Recruiting
Horsham, 19044 - Pennsylvania
Contact: Joseph Potz
United States
Texas Oncology-Baylor USO
Recruiting
Dallas, 75246 - Texas
Contact: Moshe Levy
United States
University of Texas MD Anderson Cancer Center
Recruiting
Houston, 77030 - Texas
Contact: (713-792-2921) Guillermo Garcia-Manero
United States
Texas Oncology San Antonio USO
Recruiting
San Antonio, 78240 - Texas
Contact: Roger Lyons
United States
Ironwood Cancer and Research Centers
Recruiting
Chandler, 85224 - Arizona
Contact: (480-855-2225) Mikhail I Shtivelband
United States
Arizona Oncology Associates Arizona Oncology Assoc PC
Recruiting
Phoenix, 85016 - Arizona
Contact: (520-877-9096) Sudhir Manda
United States
Mayo Clinic Arizona
Recruiting
Phoenix, 85054 - Arizona
Contact: (480-342-2545) Cecilia Arana Yi
United States
Arizona Oncology Associates
Recruiting
Tucson, 85745 - Arizona
Contact: Sudhir Manda
United States
Arizona Oncology Associates
Recruiting
Tucson, 85745 - Arizona
Contact: Manda Sudhir
United States
SCRI- Colorado Blood Cancer Institute
Recruiting
Denver, 80218 - Colorado
Contact: (720-754-4800) Alireza Eghtedar
United States
Illinois Cancer Care P.C. IL Cancer Specialists
Recruiting
Peoria, 61615-7828 - Illinois
Contact: (847-827-0319) Leonard Klein
United States
Illinois Cancer Care P.C.
Recruiting
Peoria, 61615-7828 - Illinois
Contact: Leonard Klein
United States
University of Massachusetts Medical Center
Recruiting
Worcester, 01655 - Massachusetts
Contact: (508-856-1767) Jonathan Gerber
United States
University of Michigan
Recruiting
Ann Arbor, 48109 - Michigan
Contact: Patrick W Burke
United States
Karmanos Cancer Institute Div.of Hematology/Oncology
Recruiting
Detroit, 48201 - Michigan
Contact: (313-576-8730) Jay Yang
United States
Tisch Hospital NYU Langone
Recruiting
New York, 10016 - New York
Contact: Mohammad Maher Abdul Hay
United States
Messino Cancer Centers
Recruiting
Asheville, 28806 - North Carolina
Contact: Christopher Chay
United States
University Hospitals of Cleveland
Recruiting
Cleveland, 44106 - Ohio
Contact: (*Various See Departments*) Benjamin Tomlinson
United States
Alliance Cancer Specialists USO
Recruiting
Horsham, 19044 - Pennsylvania
Contact: Joseph Potz
United States
Texas Oncology-Baylor USO
Recruiting
Dallas, 75246 - Texas
Contact: Moshe Levy
United States
University of Texas MD Anderson Cancer Center
Recruiting
Houston, 77030 - Texas
Contact: (713-792-2921) Guillermo Garcia-Manero
United States
Texas Oncology San Antonio USO
Recruiting
San Antonio, 78240 - Texas
Contact: Roger Lyons
United States

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]