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NCT Number: NCT04817007

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)

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Myelofibrosis Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myeloproliferative Disorders Primary Myelofibrosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Local Institution - 0036, Blacktown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986158

Drug

Specified dose on specified days

Ruxolitinib

Drug

Specified dose on specified days

Other names: Jakafi®

Fedratinib

Drug

Specified dose on specified days

Primary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: Up to 52 months

  2. Incidence of serious adverse events (SAEs)

    Time frame: Up to 52 months

  3. Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria

    Time frame: Up to 26 months

  4. Incidence of AEs leading to discontinuation

    Time frame: Up to 52 months

  5. Incidence of death

    Time frame: Up to 52 months

Secondary outcomes

  1. Response rate defined as proportion of participants with SVR ≥ 35% by MRI (preferred) or CT (if MRI is contraindicated and if CT is allowed by local guidelines) assessed by BICR

    Time frame: Up to 175 days

  2. Response rate defined as proportion of participants with SVR ≥ 25% by MRI (preferred) or CT (if MRI is contraindicated and if CT is allowed by local guidelines) assessed by BICR

    Time frame: Up to 175 days

  3. Symptom response rate (SRR) based on total symptom score (TSS) measured by Myelofibrosis Symptom Assessment Form (MFSAF)

    Time frame: Up to 175 days

  4. Additional measures based on TSS measured by MFSAF

    Time frame: Up to 175 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1b/2 Study of BMS-986158 Monotherapy and in Combination With Either Ruxolitinib or Fedratinib in Participants With DIPSS-Intermediate or High Risk Myelofibrosis

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Mar 25, 2021
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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