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)

ID#: NCT04817007

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 1/Phase 2

Recruitment Status: Recruiting

Start Date: March 23, 2021

End Date: April 26, 2027

Contact Information:
BMS Study Connect Contact Center www.BMSStudyConnect.com
855-907-3286
First line of the email MUST contain NCT # and Site #.
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.
Eligibility:

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
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