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)
- Conditions
- Myelofibrosis
- Interventions
- Registration Number
- NCT04817007
- Lead Sponsor
- Bristol-Myers Squibb
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 216
- 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
- Women who are pregnant or breastfeeding at screening
- Any significant acute or uncontrolled chronic medical illness
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 2B1: BMS-986158 + Fedratinib Fedratinib - Part 2A3: BMS-986158 + Ruxolitinib BMS-986158 - Part 2A3: BMS-986158 + Ruxolitinib Ruxolitinib - Part 1A: BMS-986158 + Ruxolitinib BMS-986158 - Part 1A: BMS-986158 + Ruxolitinib Ruxolitinib - Part 1B: BMS-986158 + Fedratinib BMS-986158 - Part 1B: BMS-986158 + Fedratinib Fedratinib - Part 2A1: BMS-986158 + Ruxolitinib BMS-986158 - Part 2B1: BMS-986158 + Fedratinib BMS-986158 - Part 2A1: BMS-986158 + Ruxolitinib Ruxolitinib - Part 2B2: BMS-986158 Mono and/or (BMS-986158 + Fedratinib), if applicable Fedratinib - Part 2A2 Add-On: BMS-986158 + Ruxolitinib Ruxolitinib - Part 2B2: BMS-986158 Mono and/or (BMS-986158 + Fedratinib), if applicable BMS-986158 - Part 2A2 Add-On: BMS-986158 + Ruxolitinib BMS-986158 -
- Primary Outcome Measures
Name Time Method Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria Up to 26 months Incidence of AEs leading to discontinuation Up to 52 months Incidence of death Up to 52 months Incidence of adverse events (AEs) Up to 52 months Incidence of serious adverse events (SAEs) Up to 52 months
- Secondary Outcome Measures
Name Time Method Spleen volume reduction (SVR) at end of Cycle 6 assessed by Blinded Independent Central Review (BICR) Up to 175 days Additional measures based on TSS measured by MFSAF Up to 175 days 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 Up to 175 days SVR at end of Cycle 3 and 6 assessed by BICR 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 Up to 175 days Symptom response rate (SRR) based on total symptom score (TSS) measured by Myelofibrosis Symptom Assessment Form (MFSAF) Up to 175 days
Trial Locations
- Locations (53)
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
Local Institution - 0045
🇺🇸Hackensack, New Jersey, United States
Local Institution - 0076
🇺🇸Chapel Hill, North Carolina, United States
Local Institution - 0042
🇺🇸Pittsburgh, Pennsylvania, United States
Local Institution - 0036
🇦🇺Blacktown, New South Wales, Australia
Local Institution - 0032
🇦🇺Wollongong, New South Wales, Australia
Scroll for more (43 remaining)Local Institution - 0069🇺🇸Newport Beach, California, United States