Active — Not RecruitingPhase 1/2

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)

United States216 participantsStarted 2021-03-22

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Incidence of adverse events (AEs)

Timeframe: Up to 52 months

Incidence of serious adverse events (SAEs)

Timeframe: Up to 52 months

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

Timeframe: Up to 26 months

Incidence of AEs leading to discontinuation

Timeframe: Up to 52 months

Incidence of death

Timeframe: Up to 52 months

Trial details

NCT IDNCT04817007

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-08-31

View on ClinicalTrials.gov More Myelofibrosis trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Incidence of adverse events (AEs)

Timeframe: Up to 52 months

Incidence of serious adverse events (SAEs)

Timeframe: Up to 52 months

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

Timeframe: Up to 26 months

Incidence of AEs leading to discontinuation

Timeframe: Up to 52 months

Incidence of death

Timeframe: Up to 52 months