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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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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)

  • Clinicaltrials.gov identifier

    NCT04817007

  • Recruitment Status

    Recruiting

  • First Posted

    March 25, 2021

  • Last update posted

    November 30, 2021

Study Description

Brief 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.

  • Condition or Disease:Myelofibrosis
  • Intervention/Treatment: Drug: BMS-986158
    Drug: Ruxolitinib
    Drug: Fedratinib
  • Phase: Phase 1

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 156 participants
  • Allocation: Randomized
  • Intervention Model: Sequential Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Phase 1b Study of BMS-986158 Monotherapy and in Combination With Either Ruxolitinib or Fedratinib in Participants With DIPSS-Intermediate or High Risk Myelofibrosis
  • Actual Study Start Date: March 2021
  • Estimated Primary Completion Date: November 2023
  • Estimated Study Completion Date: August 2026

Arms and interventions

Arm Intervention/treatment
Experimental: Part 1A: BMS-986158 + Ruxolitinib
Drug: BMS-986158
Specified dose on specified days

Drug: Ruxolitinib
Specified dose on specified days
Experimental: Part 1B: BMS-986158 + Fedratinib
Drug: BMS-986158
Specified dose on specified days

Drug: Fedratinib
Specified dose on specified days
Experimental: Part 2A: BMS-986158 + Ruxolitinib
Drug: BMS-986158
Specified dose on specified days

Drug: Ruxolitinib
Specified dose on specified days
Experimental: Part 2B1: BMS-986158 + Fedratinib
Drug: BMS-986158
Specified dose on specified days

Drug: Fedratinib
Specified dose on specified days
Experimental: Part 2B2: BMS-986158 Mono and/or (BMS-986158 + Fedratinib), if applicable
Drug: BMS-986158
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Incidence of adverse events (AEs) [ Time Frame: Up to 52 months ]
  • 2. Incidence of serious adverse events (SAEs) [ Time Frame: Up to 52 months ]
  • 3. Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria [ Time Frame: Up to 26 months ]
  • 4. Incidence of AEs leading to discontinuation [ Time Frame: Up to 52 months ]
  • 5. Incidence of death [ Time Frame: Up to 52 months ]
  • Secondary Outcome Measures: 1. Spleen volume reduction (SVR) at end of Cycle 6 assessed by Blinded Independent Central Review (BICR) [ Time Frame: Up to 52 months ]
  • 2. Response rate defined as proportion of participants with SVR ≥ 35% by MRI (preferred) or CT (if MRI is contraindicated) assessed by BICR [ Time Frame: Up to 52 months ]
  • 3. Symptom response rate (SRR) based on total symptom score (TSS) measured by Myelofibrosis Symptom Assessment Form (MFSAF) [ Time Frame: Up to 168 days ]
  • 4. Additional measures based on TSS measured by MFSAF [ Time Frame: Up to 168 days ]
  • 5. For transfusion independent (TI), proportion of participants having ≥ 2.0 g/dL hemoglobin (Hgb) increase over baseline [ Time Frame: Up to 24 months ]
  • 6. For transfusion dependent (TD), proportion of participants becoming TI as measured by the absence of red blood cell (RBC) transfusions over any consecutive 12-week period [ Time Frame: Up to 24 months ]
  • 7. Summary of pharmacokinetics (PK) parameters: maximum observed concentration (Cmax) [ Time Frame: Up to 56 days ]
  • 8. Summary of PK parameters: time of maximum observed concentration (Tmax) [ Time Frame: Up to 56 days ]
  • 9. Summary of PK parameters: area under the concentration-time curve from time zero to the time of the last quantifiable concentration ((AUC (0-T)) [ Time Frame: Up to 56 days ]
  • 10. Time from Dose 1, Day 1 to death due to any reason or disease progression (per modified IWG-MRT 2013) assessed by BICR: SDPFS rates at 6 months and 12 months [ Time Frame: 6 month and 12 month ]
    International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) Spleen and disease progression free survival (SDPFS)
  • 11. Time from Dose 1, Day 1 to death due to any reason or disease progression (per modified IWG-MRT 2013) assessed by BICR: median SDPFS at 6 months and 12 months [ Time Frame: 6 month and 12 month ]

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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

Contacts and Locations

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

United States, California
Local Institution
La Jolla

United States, Massachusetts
Local Institution
Worcester

United States, Michigan
Local Institution
Ann Arbor

United States, Texas
Local Institution
San Antonio

Australia, New South Wales
Local Institution
Blacktown

Australia, New South Wales
Local Institution
Wollongong

Australia, Victoria
Local Institution
Heidelberg

Australia, Victoria
Epworth Freemasons
Melbourne

Australia, Western Australia
The Perth Blood Institute - West Perth
West Perth

France
Local Institution
Brest

France
Institut Paoli-Calmettes-Hematology
Marseille

France
Local Institution
Nice

France
Hôpital Saint-Louis-Centre d'Investigations Cliniques
Paris

France
Gustave Roussy-DITEP
Villejuif

Israel
Local Institution
Jerusalem

Israel
Local Institution
Petah Tikva

Israel
Local Institution
Ramat Gan

Israel
Local Institution
Tel Aviv

Italy
Local Institution
Bologna

Italy
Local Institution
Brescia

Italy
Local Institution
Firenze

Italy
Local Institution
Verona

Spain
Local Institution
Badalona

Spain
Local Institution
Madrid

Spain
Local Institution
Salamanca

Spain
Local Institution
Santander

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT04817007 History of Changes
  • Other Study ID Numbers: CA011-023, 2020-002071-35
  • First Posted: March 25, 2021 Key Record Dates
  • Last Update Posted: November 30, 2021
  • Last Verified: November 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Keywords provided by Bristol-Myers Squibb: BMS-986158
    Fedratinib
    Myelofibrosis
    Ruxolitinib
  • Additional relevant MeSH terms: Primary Myelofibrosis
    Myeloproliferative Disorders
    Bone Marrow Diseases
    Hematologic Diseases