A Study to Assess the Safety and Tolerability of BMS-986158 Alone and in Combination With Either Ruxolitinib or Fedratinib in Participants With Blood Cancer (Myelofibrosis)

  • STATUS
    Recruiting
  • End date
    Apr 26, 2027
  • participants needed
    192
  • sponsor
    Bristol-Myers Squibb
Updated on 10 August 2022

Summary

The purpose of this study is to assess the safety, tolerability, and efficacy of BMS-986158 alone and in combination with either Ruxolitinib or Fedratinib in participants with Dynamic International Prognostic Scoring System (DIPSS)-intermediate or high risk blood cancer. Part 1 consists of BMS-986158 in combination with either Ruxolitinib or Fedratinib and Part 2 consists of BMS-986158 in combination with either Ruxolitinib or Fedratinib and BMS-986158 alone.

Details
Condition Myelofibrosis
Treatment Ruxolitinib, BMS-986158, FEDRATINIB
Clinical Study IdentifierNCT04817007
SponsorBristol-Myers Squibb
Last Modified on10 August 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of primary myelofibrosis (PMF), post-essential thrombocythemia (ET) or post-polycythemia vera (PV) myelofibrosis
Treatment-related toxicities from prior therapy resolved to Grade 1 or pre-treatment baseline or determined to be irreversible prior to study treatment
Must agree to follow specific methods of contraception, if applicable

Exclusion Criteria

Women who are pregnant or breastfeeding at screening
Any significant acute or uncontrolled chronic medical illness
Other protocol-defined inclusion/exclusion criteria apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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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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