NCT04817007Active, 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)
A Phase 1b/2 Study of BMS-986158 Monotherapy and in Combination With Either Ruxolitinib or Fedratinib in Participants With DIPSS-Intermediate or High Risk Myelofibrosis
Source: ClinicalTrials.gov · Last updated 8 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 216 (estimated)
- First submitted
- 18 Mar 2021
- Start date
- 22 Mar 2021
- Primary completion date
- 31 Aug 2028
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Myeloproliferative neoplasms
- NCT number
- NCT04817007
- EudraCT number
- 2023-509635-89
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 216
- From 22 Mar 2021 to the primary completion date, 31 Aug 2028
- 49 sites in 11 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any significant acute or uncontrolled chronic medical illness
- Other protocol-defined inclusion/exclusion criteria apply
Other
- Women who are pregnant or breastfeeding at screening
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (49)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Local Institution - 0036 Coordinator of this site? Confirm its status | Blacktown | Australia | Unknown status |
| Local Institution - 0007 Coordinator of this site? Confirm its status | East Melbourne | Australia | Unknown status |
| Local Institution - 0006 Coordinator of this site? Confirm its status | Heidelberg | Australia | Unknown status |
| Local Institution - 0041 Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| Local Institution - 0015 Coordinator of this site? Confirm its status | West Perth | Australia | Unknown status |
| Local Institution - 0032 Coordinator of this site? Confirm its status | Wollongong | Australia | Unknown status |
| Local Institution - 0040 Coordinator of this site? Confirm its status | Chemnitz | Germany | Unknown status |
| Local Institution - 0068 Coordinator of this site? Confirm its status | Erding | Germany | Unknown status |
| Local Institution - 0039 Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Local Institution - 0035 Coordinator of this site? Confirm its status | Halle | Germany | Unknown status |
| Local Institution - 0050 Coordinator of this site? Confirm its status | Lübeck | Germany | Unknown status |
| Local Institution - 0020 Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| Local Institution - 0026 Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Local Institution - 0054 Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Local Institution - 0021 Coordinator of this site? Confirm its status | Salamanca | Spain | Unknown status |
| Local Institution - 0029 Coordinator of this site? Confirm its status | Santander | Spain | Unknown status |
| Local Institution - 0094 Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Local Institution - 0030 Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| Local Institution - 0008 Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Local Institution - 0027 Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| Local Institution - 0011 Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Local Institution - 0010 Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
| Local Institution - 0061 Coordinator of this site? Confirm its status | Chaïdári | Greece | Unknown status |
| Local Institution - 0047 Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| Local Institution - 0086 Coordinator of this site? Confirm its status | Beersheba | Israel | Unknown status |
| Local Institution - 0016 Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Local Institution - 0018 Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| Local Institution - 0017 Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Local Institution - 0019 Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Local Institution - 0003 Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Local Institution - 0002 Coordinator of this site? Confirm its status | Brescia | Italy | Unknown status |
| Local Institution - 0001 Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Local Institution - 0012 Coordinator of this site? Confirm its status | Verona | Italy | Unknown status |
| Local Institution - 0049 Coordinator of this site? Confirm its status | Seongnam | South Korea | Unknown status |
| Local Institution - 0053 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Local Institution - 0048 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Local Institution - 0062 Coordinator of this site? Confirm its status | Gdansk | Poland | Unknown status |
| Local Institution - 0077 Coordinator of this site? Confirm its status | Słupsk | Poland | Unknown status |
| Local Institution - 0083 Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
| Local Institution - 0052 Coordinator of this site? Confirm its status | Bucuresti | Romania | Unknown status |
| Local Institution - 0051 Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Unknown status |
| Local Institution - 0033 Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Local Institution - 0076 Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Local Institution - 0045 Coordinator of this site? Confirm its status | Hackensack | United States | Unknown status |
| Local Institution - 0090 Coordinator of this site? Confirm its status | Lake Mary | United States | Unknown status |
| Local Institution - 0043 Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Local Institution - 0069 Coordinator of this site? Confirm its status | Newport Beach | United States | Unknown status |
| Local Institution - 0042 Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Local Institution - 0038 Coordinator of this site? Confirm its status | Worcester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.