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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)
Sponsor: Bristol-Myers Squibb
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
216
Start Date
2021-03-22
Completion Date
2026-05-31
Last Updated
2025-09-10
Healthy Volunteers
No
Conditions
Interventions
BMS-986158
Specified dose on specified days
Ruxolitinib
Specified dose on specified days
Fedratinib
Specified dose on specified days
Locations (53)
Local Institution - 0069
Newport Beach, California, United States
Local Institution - 0090
Lake Mary, Florida, United States
Local Institution - 0043
New Orleans, Louisiana, United States
Local Institution - 0038
Worcester, Massachusetts, United States
Local Institution - 0033
Ann Arbor, Michigan, United States
Local Institution - 0045
Hackensack, New Jersey, United States
Local Institution - 0076
Chapel Hill, North Carolina, United States
Local Institution - 0042
Pittsburgh, Pennsylvania, United States
Local Institution - 0036
Blacktown, New South Wales, Australia
Local Institution - 0032
Wollongong, New South Wales, Australia
Local Institution - 0007
East Melbourne, Victoria, Australia
Local Institution - 0006
Heidelberg, Victoria, Australia
Local Institution - 0041
Nedlands, Western Australia, Australia
Local Institution - 0015
West Perth, Western Australia, Australia
Local Institution - 0030
Brest, France
Local Institution - 0008
Marseille, France
Local Institution - 0027
Nice, France
Local Institution - 0011
Paris, France
Local Institution - 0010
Villejuif, France
Local Institution - 0068
Erding, Bavaria, Germany
Local Institution - 0039
Essen, North Rhine-Westphalia, Germany
Local Institution - 0040
Chemnitz, Saxony, Germany
Local Institution - 0035
Halle, Saxony-Anhalt, Germany
Local Institution - 0050
Lübeck, Schleswig-Holstein, Germany
Local Institution - 0061
Chaïdári, Attikí, Greece
Local Institution - 0047
Thessaloniki, Thessaloníki, Greece
Local Institution - 0073
Szeged, Csongrád megye, Hungary
Local Institution - 0072
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
Local Institution - 0075
Budapest, Hungary
Local Institution - 0074
Debrecen, Hungary
Local Institution - 0086
Beersheba, Southern District, Israel
Local Institution - 0016
Jerusalem, Israel
Local Institution - 0018
Petah Tikva, Israel
Local Institution - 0017
Ramat Gan, Israel
Local Institution - 0019
Tel Aviv, Israel
Local Institution - 0003
Bologna, Italy
Local Institution - 0002
Brescia, Italy
Local Institution - 0001
Florence, Italy
Local Institution - 0012
Verona, Italy
Local Institution - 0077
Słupsk, Pomeranian Voivodeship, Poland
Local Institution - 0062
Gdansk, Poland
Local Institution - 0052
Bucuresti, Cluj, Romania
Local Institution - 0083
Bucharest, Romania
Local Institution - 0051
Cluj-Napoca, Romania
Local Institution - 0049
Seongnam, Kyǒnggi-do, South Korea
Local Institution - 0048
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0053
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0020
Badalona, Barcelona [Barcelona], Spain
Local Institution - 0029
Santander, Cantabria, Spain
Local Institution - 0054
Madrid, Madrid, Comunidad de, Spain
Local Institution - 0026
Madrid, Spain
Local Institution - 0021
Salamanca, Spain
Local Institution - 0094
Valencia, Spain