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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)
NCT04817007 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG Ruxolitinib
- DRUG BMS-986158
- DRUG Fedratinib
Study Locations (20)
Other
- Local Institution - 0030 — Brest
- Local Institution - 0008 — Marseille
- Local Institution - 0027 — Nice
- Local Institution - 0011 — Paris
- Local Institution - 0010 — Villejuif
New South Wales
- Local Institution - 0036 — Blacktown
- Local Institution - 0032 — Wollongong
Victoria
- Local Institution - 0007 — East Melbourne
- Local Institution - 0006 — Heidelberg
Western Australia
- Local Institution - 0041 — Nedlands
- Local Institution - 0015 — West Perth
California
- Local Institution - 0069 — Newport Beach
Florida
- Local Institution - 0090 — Lake Mary
Louisiana
- Local Institution - 0043 — New Orleans
Massachusetts
- Local Institution - 0038 — Worcester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 216 participants |
| Start Date | 2021-03-22 |
| Est. Completion | 2026-05-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04817007
The ClinicalTrials.gov registry entry for NCT04817007 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 216 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 504 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Myelofibrosis appearing as the primary indexed condition, and to 3 interventions — of which Ruxolitinib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04817007 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, New South Wales, Victoria. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04817007 about?
NCT04817007 is a clinical study titled "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)". 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-98615...
What is the current status of trial NCT04817007?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 216 participants. The study started on 2021-03-22. Estimated completion is 2026-05-31.
What conditions does trial NCT04817007 study?
This clinical trial studies the following conditions: Myelofibrosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04817007?
The interventions under investigation include: Ruxolitinib (DRUG), BMS-986158 (DRUG), Fedratinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04817007?
This trial is sponsored by Bristol-Myers Squibb, which has 504 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04817007 being conducted?
This trial has 20 study locations across California, Florida, Louisiana, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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