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)

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Myelofibrosis

Interventions

Type	Name	Description
DRUG	BMS-986158	Specified dose on specified days
DRUG	Ruxolitinib	Specified dose on specified days
DRUG	Fedratinib	Specified dose on specified days

Timeline

• Start date: 2021-03-22
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2021-03-25
• Last updated: 2025-09-10

Locations

53 sites across 12 countries: United States, Australia, France, Germany, Greece, Hungary, Israel, Italy, Poland, Romania, South Korea, Spain

Regulatory

• FDA-regulated drug study