Sign in

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
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

Full criteria on ClinicalTrials.gov

Sites (49)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Local Institution - 0036
Coordinator of this site? Confirm its status
BlacktownAustraliaUnknown status
Local Institution - 0007
Coordinator of this site? Confirm its status
East MelbourneAustraliaUnknown status
Local Institution - 0006
Coordinator of this site? Confirm its status
HeidelbergAustraliaUnknown status
Local Institution - 0041
Coordinator of this site? Confirm its status
NedlandsAustraliaUnknown status
Local Institution - 0015
Coordinator of this site? Confirm its status
West PerthAustraliaUnknown status
Local Institution - 0032
Coordinator of this site? Confirm its status
WollongongAustraliaUnknown status
Local Institution - 0040
Coordinator of this site? Confirm its status
ChemnitzGermanyUnknown status
Local Institution - 0068
Coordinator of this site? Confirm its status
ErdingGermanyUnknown status
Local Institution - 0039
Coordinator of this site? Confirm its status
EssenGermanyUnknown status
Local Institution - 0035
Coordinator of this site? Confirm its status
HalleGermanyUnknown status
Local Institution - 0050
Coordinator of this site? Confirm its status
LübeckGermanyUnknown status
Local Institution - 0020
Coordinator of this site? Confirm its status
BadalonaSpainUnknown status
Local Institution - 0026
Coordinator of this site? Confirm its status
MadridSpainUnknown status
Local Institution - 0054
Coordinator of this site? Confirm its status
MadridSpainUnknown status
Local Institution - 0021
Coordinator of this site? Confirm its status
SalamancaSpainUnknown status
Local Institution - 0029
Coordinator of this site? Confirm its status
SantanderSpainUnknown status
Local Institution - 0094
Coordinator of this site? Confirm its status
ValenciaSpainUnknown status
Local Institution - 0030
Coordinator of this site? Confirm its status
BrestFranceUnknown status
Local Institution - 0008
Coordinator of this site? Confirm its status
MarseilleFranceUnknown status
Local Institution - 0027
Coordinator of this site? Confirm its status
NiceFranceUnknown status
Local Institution - 0011
Coordinator of this site? Confirm its status
ParisFranceUnknown status
Local Institution - 0010
Coordinator of this site? Confirm its status
VillejuifFranceUnknown status
Local Institution - 0061
Coordinator of this site? Confirm its status
ChaïdáriGreeceUnknown status
Local Institution - 0047
Coordinator of this site? Confirm its status
ThessalonikiGreeceUnknown status
Local Institution - 0086
Coordinator of this site? Confirm its status
BeershebaIsraelUnknown status
Local Institution - 0016
Coordinator of this site? Confirm its status
JerusalemIsraelUnknown status
Local Institution - 0018
Coordinator of this site? Confirm its status
Petah TikvaIsraelUnknown status
Local Institution - 0017
Coordinator of this site? Confirm its status
Ramat GanIsraelUnknown status
Local Institution - 0019
Coordinator of this site? Confirm its status
Tel AvivIsraelUnknown status
Local Institution - 0003
Coordinator of this site? Confirm its status
BolognaItalyUnknown status
Local Institution - 0002
Coordinator of this site? Confirm its status
BresciaItalyUnknown status
Local Institution - 0001
Coordinator of this site? Confirm its status
FlorenceItalyUnknown status
Local Institution - 0012
Coordinator of this site? Confirm its status
VeronaItalyUnknown status
Local Institution - 0049
Coordinator of this site? Confirm its status
SeongnamSouth KoreaUnknown status
Local Institution - 0053
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Local Institution - 0048
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Local Institution - 0062
Coordinator of this site? Confirm its status
GdanskPolandUnknown status
Local Institution - 0077
Coordinator of this site? Confirm its status
SłupskPolandUnknown status
Local Institution - 0083
Coordinator of this site? Confirm its status
BucharestRomaniaUnknown status
Local Institution - 0052
Coordinator of this site? Confirm its status
BucurestiRomaniaUnknown status
Local Institution - 0051
Coordinator of this site? Confirm its status
Cluj-NapocaRomaniaUnknown status
Local Institution - 0033
Coordinator of this site? Confirm its status
Ann ArborUnited StatesUnknown status
Local Institution - 0076
Coordinator of this site? Confirm its status
Chapel HillUnited StatesUnknown status
Local Institution - 0045
Coordinator of this site? Confirm its status
HackensackUnited StatesUnknown status
Local Institution - 0090
Coordinator of this site? Confirm its status
Lake MaryUnited StatesUnknown status
Local Institution - 0043
Coordinator of this site? Confirm its status
New OrleansUnited StatesUnknown status
Local Institution - 0069
Coordinator of this site? Confirm its status
Newport BeachUnited StatesUnknown status
Local Institution - 0042
Coordinator of this site? Confirm its status
PittsburghUnited StatesUnknown status
Local Institution - 0038
Coordinator of this site? Confirm its status
WorcesterUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.