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No longer recruiting (closed or complete)Last updated: 22 May 2025

This phase I trial aims to understand how safe, well tolerated and effective a new targeted cancer drug (BMS-986158) is in people with DIPSS-intermediate or high risk Myelofibrosis, when given alone or in combination with targeted cancer treatment (Ruxolitinib or Fedratinib)A Phase 1b Study of BMS-986158 Monotherapy and in Combination With Either Ruxolitinib or Fedratinib in Participants With DIPSS-Intermediate or High Risk Myelofibrosis

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Clinical summary

Summary

This trial contains two parts. Part 1 will compare the combination of BMS-986158 with either Ruxolitinib or Fedratinib and Part 2 will compared these combinations with BMS-986158 alone.

Conditions

This trial is treating people with Dynamic International Prognostic Scoring System (DIPSS)-Intermediate or High Risk Myelofibrosis

Eligibility

Inclusion

  • 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

  • Women who are pregnant or breastfeeding at screening
  • Any significant acute or uncontrolled chronic medical illness

Other protocol-defined inclusion/exclusion criteria apply

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Bristol-Myers Squibb (BMS)

Scientific Title

A Phase 1b Study of BMS-986158 Monotherapy and in Combination With Either Ruxolitinib or Fedratinib in Participants With DIPSS-Intermediate or High Risk Myelofibrosis

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