Myelodysplastic Syndrome Clinical Trial

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

Summary

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))

View Full Description

Full Description

This is a single-arm, non- randomized, open label, phase II multi-center study of intravenous MBG453 (sabatolimab) added to FDA approved Hypomethylating agents of investigator's choice (IV/SC/ Oral) in adult participants with intermediate, high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R criteria.

There are three separate periods of this study:

Screening period (signing of written informed consent through Day 1);
Core phase for 24 months (with post treatment safety follow-up monitoring for adverse events (AEs) for 30 days following the last dose of azacitidine or decitabine or INQOVI (oral decitabine), or 150 days following the last dose of MBG453 (sabatolimab), whichever is later);
Extension phase for efficacy and/or survival status (up to 36 months from last patient enrolling) (with post treatment safety follow-up monitoring for adverse events (AEs) for 30 days following the last dose of azacitidine or decitabine or INQOVI (oral decitabine), or 150 days following the last dose of MBG453 (sabatolimab), whichever is later).

View Eligibility Criteria

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 is for people with:

Myelodysplastic Syndrome

Phase:

Phase 2

Estimated Enrollment:

90

Study ID:

NCT04878432

Recruitment Status:

Recruiting

Sponsor:

Novartis Pharmaceuticals

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 21 Locations for this study

See Locations Near You

Ironwood Cancer and Research Centers
Chandler Arizona, 85224, United States More Info
Contact
480-855-2225
Mikhail I Shtivelband
Principal Investigator
Arizona Oncology Associates Arizona Oncology Assoc PC
Phoenix Arizona, 85016, United States More Info
Contact
520-877-9096
Sudhir Manda
Principal Investigator
Mayo Clinic Arizona
Phoenix Arizona, 85054, United States More Info
Contact
480-342-2545
Cecilia Arana Yi
Principal Investigator
Arizona Oncology Associates
Tucson Arizona, 85745, United States More Info
Sudhir Manda
Principal Investigator
Arizona Oncology Associates
Tucson Arizona, 85745, United States More Info
Manda Sudhir
Principal Investigator
SCRI- Colorado Blood Cancer Institute
Denver Colorado, 80218, United States More Info
Contact
720-754-4800
Alireza Eghtedar
Principal Investigator
Yale University School of Medicine
New Haven Connecticut, 06520, United States More Info
Amer Zeidan
Principal Investigator
AdventHealth Orlando
Orlando Florida, 32803, United States More Info
Contact
407-303-5600
Carlos Alemany
Principal Investigator
Illinois Cancer Care P.C. IL Cancer Specialists
Peoria Illinois, 61615, United States More Info
Contact
847-827-0319
Leonard Klein
Principal Investigator
Illinois Cancer Care P.C.
Peoria Illinois, 61615, United States More Info
Leonard Klein
Principal Investigator
University of Massachusetts Medical Center
Worcester Massachusetts, 01655, United States More Info
Contact
508-856-1767
Jonathan Gerber
Principal Investigator
University of Michigan
Ann Arbor Michigan, 48109, United States More Info
Patrick William Burke
Principal Investigator
Karmanos Cancer Institute Div.of Hematology/Oncology
Detroit Michigan, 48201, United States More Info
Contact
313-576-8730
Jay Yang
Principal Investigator
Tisch Hospital NYU Langone
New York New York, 10016, United States More Info
Mohammad Maher Abdul Hay
Principal Investigator
Mount Sinai Medical Center
New York New York, 10029, United States More Info
Lewis Silverman
Principal Investigator
Messino Cancer Centers
Asheville North Carolina, 28806, United States More Info
Christopher Chay
Principal Investigator
Duke Cancer Institute
Durham North Carolina, 27710, United States More Info
Carlos Manuel de Castro
Principal Investigator
University Hospitals of Cleveland
Cleveland Ohio, 44106, United States More Info
Benjamin Tomlinson
Principal Investigator
Cleveland Clinic
Cleveland Ohio, 44195, United States More Info
Contact
216-445-6724
Hetty Carraway
Principal Investigator
Alliance Cancer Specialists USO
Horsham Pennsylvania, 19044, United States More Info
Joseph Potz
Principal Investigator
Texas Oncology-Baylor USO
Dallas Texas, 75246, United States More Info
Moshe Levy
Principal Investigator
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Contact
713-792-2921
Guillermo Garcia-Manero
Principal Investigator
Texas Oncology San Antonio USO
San Antonio Texas, 78240, United States More Info
Roger Lyons
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 2

Estimated Enrollment:

90

Study ID:

NCT04878432

Recruitment Status:

Recruiting

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.