BMS-986158 + Ruxolitinib/Fedratinib for Myelofibrosis

Recruiting in Palo Alto (17 mi)

+132 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Bristol-Myers Squibb

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial is testing a new drug called BMS-986158 for patients with high-risk blood cancer. It aims to see if the drug works better alone or when combined with existing treatments, Ruxolitinib and Fedratinib. Ruxolitinib is the first FDA-approved JAK inhibitor for myeloproliferative neoplasms, effective in controlling symptoms and improving splenomegaly, but many patients develop disease progression with long-term use.

Eligibility Criteria

This trial is for adults with a type of blood cancer called myelofibrosis, who are at intermediate or high risk. They must not have unresolved serious side effects from previous treatments and agree to use contraception if needed. Pregnant or breastfeeding women, those with acute illnesses or uncontrolled chronic conditions are excluded.

Inclusion Criteria

Must agree to follow specific methods of contraception, if applicable

My side effects from previous treatments have mostly gone away or are stable.

I have been diagnosed with a type of myelofibrosis.

Exclusion Criteria

I am not pregnant or breastfeeding.

I do not have any severe or unmanaged chronic illnesses.

There are other criteria set by the study that determine if you can participate or not.

Participant Groups

The study tests the safety and effectiveness of BMS-986158 alone, and in combination with Ruxolitinib or Fedratinib. Participants will be divided into two parts: one part receiving combinations and the other receiving BMS-986158 alone to compare outcomes.

7Treatment groups

Experimental Treatment

Group I: Part 2B2: BMS-986158 Mono and/or (BMS-986158 + Fedratinib), if applicableExperimental Treatment2 Interventions

Group II: Part 2B1: BMS-986158 + FedratinibExperimental Treatment2 Interventions

Group III: Part 2A3: BMS-986158 + RuxolitinibExperimental Treatment2 Interventions

Group IV: Part 2A2 Add-On: BMS-986158 + RuxolitinibExperimental Treatment2 Interventions

Group V: Part 2A1: BMS-986158 + RuxolitinibExperimental Treatment2 Interventions

Group VI: Part 1B: BMS-986158 + FedratinibExperimental Treatment2 Interventions

Group VII: Part 1A: BMS-986158 + RuxolitinibExperimental Treatment2 Interventions