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)

Bristol-Myers Squibb (BMS)

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Myelofibrosis

Treatments: Drug: Ruxolitinib; Drug: Fedratinib; Drug: BMS-986158

Study type: Interventional

Funder types: Industry

Identifiers

NCT04817007

2020-002071-35 (EudraCT Number)

CA011-023

Details and patient eligibility

About

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.

Enrollment: 216 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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216 participants in 7 patient groups

Part 1A: BMS-986158 + Ruxolitinib

Experimental group

Treatment:

Drug: BMS-986158

Drug: Ruxolitinib

Part 1B: BMS-986158 + Fedratinib

Experimental group

Treatment:

Drug: Fedratinib

Drug: BMS-986158

Part 2A1: BMS-986158 + Ruxolitinib

Experimental group

Treatment:

Drug: BMS-986158

Drug: Ruxolitinib

Part 2B1: BMS-986158 + Fedratinib

Experimental group

Treatment:

Drug: Fedratinib

Drug: BMS-986158

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

Experimental group

Treatment:

Drug: Fedratinib

Drug: BMS-986158

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

Experimental group

Treatment:

Drug: BMS-986158

Drug: Ruxolitinib

Part 2A3: BMS-986158 + Ruxolitinib

Experimental group

Treatment:

Drug: BMS-986158

Drug: Ruxolitinib