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)

Phase 2Active Not RecruitingNCT04817007

Bristol-Myers Squibb216 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

216

Conditions

Myelofibrosis

Interventions

BMS-986158DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (49)

Local Institution - 0069

Newport Beach, California, United States

Local Institution - 0090

Lake Mary, Florida, United States

Local Institution - 0043

New Orleans, Louisiana, United States

Local Institution - 0038

Worcester, Massachusetts, United States

Local Institution - 0033

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Incidence of adverse events (AEs)

Time frame: Up to 52 months

Incidence of serious adverse events (SAEs)

Time frame: Up to 52 months

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

Time frame: Up to 26 months

Incidence of AEs leading to discontinuation

Time frame: Up to 52 months

Incidence of death

Time frame: Up to 52 months

Secondary Outcomes

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

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

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

Time frame: Up to 175 days

Additional measures based on TSS measured by MFSAF

Time frame: Up to 175 days