Myeloproliferative Neoplasms Clinical Trial

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)

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Women who are pregnant or breastfeeding at screening
Any significant acute or uncontrolled chronic medical illness

Other protocol-defined inclusion/exclusion criteria apply

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 1

Estimated Enrollment:

192

Study ID:

NCT04817007

Recruitment Status:

Recruiting

Sponsor:

Bristol-Myers Squibb

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There are 33 Locations for this study

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Moores Cancer Center-Clinical Trials Office - Hematology
La Jolla California, 92093, United States More Info
Michael Choi, Site 0028
Contact
323-899-5135
Tulane University School of Medicine
New Orleans Louisiana, 70112, United States More Info
Hana Safah, Site 0043
Contact
504-988-6070
University of Massachusetts Medical School-Division of Hematology/Oncology
Worcester Massachusetts, 01655, United States More Info
Jonathan Gerber, Site 0038
Contact
508-635-7093
University Of Michigan
Ann Arbor Michigan, 48109, United States More Info
Moshe Talpaz, Site 0033
Contact
734-647-9913
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack New Jersey, 07601, United States More Info
James McCloskey, Site 0045
Contact
551-996-3925
AHN West Penn Hospital
Pittsburgh Pennsylvania, 15224, United States More Info
Salman Fazal, Site 0042
Contact
412-578-4355
Mays Cancer Center
San Antonio Texas, 78229, United States More Info
Ruben Mesa, Site 0037
Contact
507-284-3311
Local Institution - 0036
Blacktown New South Wales, 2148, Australia More Info
Site 0036
Contact
Local Institution - 0032
Wollongong New South Wales, 2500, Australia More Info
Site 0032
Contact
Local Institution - 0007
East Melbourne Victoria, 3002, Australia More Info
Site 0007
Contact
Local Institution - 0006
Heidelberg Victoria, 3084, Australia More Info
Site 0006
Contact
Local Institution - 0041
Nedlands Western Australia, 6009, Australia More Info
Site 0041
Contact
Local Institution - 0015
West Perth Western Australia, 6005, Australia More Info
Site 0015
Contact
Local Institution - 0030
Brest , 29200, France More Info
Site 0030
Contact
Local Institution - 0008
Marseille , 13273, France More Info
Site 0008
Contact
Local Institution - 0027
Nice , 06202, France More Info
Site 0027
Contact
Local Institution - 0011
Paris , 75010, France More Info
Site 0011
Contact
Local Institution - 0010
Villejuif , 94800, France More Info
Site 0010
Contact
Local Institution - 0040
Chemnitz Sachsen, 09116, Germany More Info
Site 0040
Contact
Local Institution - 0039
Essen , 45147, Germany More Info
Site 0039
Contact
Local Institution - 0035
Halle (Saale) , 06120, Germany More Info
Site 0035
Contact
Local Institution - 0016
Jerusalem , 91120, Israel More Info
Site 0016
Contact
Local Institution - 0018
Petah-Tikva , 49100, Israel More Info
Site 0018
Contact
Local Institution - 0017
Ramat Gan , 52621, Israel More Info
Site 0017
Contact
Local Institution - 0019
Tel Aviv , 64239, Israel More Info
Site 0019
Contact
Local Institution - 0003
Bologna , 40138, Italy
Local Institution - 0002
Brescia , 25123, Italy More Info
Site 0002
Contact
Local Institution - 0001
Firenze , 50134, Italy More Info
Site 0001
Contact
Local Institution - 0012
Verona , 37134, Italy More Info
Site 0012
Contact
Local Institution - 0020
Badalona , 08916, Spain More Info
Site 0020
Contact
Local Institution - 0026
Madrid , 28041, Spain More Info
Site 0026
Contact
Local Institution - 0021
Salamanca , 37007, Spain More Info
Site 0021
Contact
Local Institution - 0029
Santander , 39008, Spain More Info
Site 0029
Contact

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 1

Estimated Enrollment:

192

Study ID:

NCT04817007

Recruitment Status:

Recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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