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RecruitingLast updated:15 August 2023

STIMULUS-MDS2: This Phase III trial is trying to understand the effect of a new immunotherapy (MBG453) in combination with chemotherapy (azacitidine) compared with azacitidine and a placebo in people with intermediate, high or very high risk myelodysplastic syndrome or chronic myelomonocytic leukaemia-2A Randomized, Double-blind, Placebo-controlled Phase III Multi-center Study of Azacitidine With or Without MBG453 for the Treatment of Patients With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)

Clinical summary

Summary

This is a randomised trial with experimental and placebo comparator arms. Participants in the Experimental Arm will receive MBG453 plus Azacitidine. A dose of MBG453 800 mg will be administered intravenously (IV) every 4 weeks (Q4W).A dose of Azacitidine 75 mg/m2 will be administered IV or subcutaneously (SC) on Day 1-7, or Day 1-5, 8 and 9. Participants in the Placebo Comparator Arm will receive a placebo plus Azacitidine. A dose of Placebo 800 mg will be administered intravenously every 4 weeks (Q4W). A dose of Azacitidine 75 mg/m2 will be administered IV or subcutaneously (SC) on Day 1-7, or Day 1-5, 8 and 9.

Age

People18+

Phase

III

Trial Acronym

STIMULUS-MDS2

More information

Trial Identifiers

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Commercial Sponsor

Novartis Pharmaceuticals

Scientific Title

A Randomized, Double-blind, Placebo-controlled Phase III Multi-center Study of Azacitidine With or Without MBG453 for the Treatment of Patients With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)

Eligibility

Inclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
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