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

  • STATUS
    Recruiting
  • End date
    Mar 31, 2025
  • participants needed
    90
  • sponsor
    Novartis Pharmaceuticals
Updated on 8 July 2022
decitabine
cell transplantation
azacitidine
EGFR

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))

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:

  1. Screening period (signing of written informed consent through Day 1);
  2. 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);
  3. 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).

Details
Condition Myelodysplastic Syndrome (MDS)
Treatment Decitabine, Azacitidine, MBG453, INQOVI (oral decitabine)
Clinical Study IdentifierNCT04878432
SponsorNovartis Pharmaceuticals
Last Modified on8 July 2022

Eligibility

Yes No Not Sure

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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