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Trial ID CA011-023  |   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)

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Summary

  • Phase 1/Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

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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Key Eligibility Criteria

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 Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Part 1A: BMS-986158 + Ruxolitinib

ASSIGNED INTERVENTION
  • Drug: Ruxolitinib, BMS-986158

Study Arms

Experimental: Part 1B: BMS-986158 + Fedratinib

ASSIGNED INTERVENTION
  • Drug: BMS-986158, Fedratinib

Study Arms

Experimental: Part 2A1: BMS-986158 + Ruxolitinib

ASSIGNED INTERVENTION
  • Drug: BMS-986158, Ruxolitinib

Study Arms

Experimental: Part 2A2 Add-On: BMS-986158 + Ruxolitinib

ASSIGNED INTERVENTION
  • Drug: Ruxolitinib, BMS-986158

Study Arms

Experimental: Part 2A3: BMS-986158 + Ruxolitinib

ASSIGNED INTERVENTION
  • Drug: Ruxolitinib, BMS-986158

Study Arms

Experimental: Part 2B1: BMS-986158 + Fedratinib

ASSIGNED INTERVENTION
  • Drug: Fedratinib, BMS-986158

Study Arms

Experimental: Part 2B2: BMS-986158 Mono and/or (BMS-986158 + Fedratinib), if applicable

ASSIGNED INTERVENTION