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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04817007
Recruitment Status : Active, not recruiting
First Posted : March 25, 2021
Last Update Posted : March 12, 2024
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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 Intervention/treatment Phase
Myelofibrosis Drug: BMS-986158 Drug: Ruxolitinib Drug: Fedratinib Phase 1 Phase 2

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 23, 2021
Estimated Primary Completion Date : April 14, 2025
Estimated Study Completion Date : April 26, 2027

Resource links provided by the National Library of Medicine


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

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

Drug: Fedratinib
Specified dose on specified days
Experimental: Part 2A1: BMS-986158 + Ruxolitinib Drug: BMS-986158
Specified dose on specified days

Drug: Ruxolitinib
Specified dose on specified days
Other Name: Jakafi®
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

Drug: Fedratinib
Specified dose on specified days
Experimental: Part 2A2 Add-On: BMS-986158 + Ruxolitinib Drug: BMS-986158
Specified dose on specified days

Drug: Ruxolitinib
Specified dose on specified days
Other Name: Jakafi®
Experimental: Part 2A3: BMS-986158 + Ruxolitinib Drug: BMS-986158
Specified dose on specified days

Drug: Ruxolitinib
Specified dose on specified days
Other Name: Jakafi®


Outcome Measures
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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 175 days ]
  2. Response rate defined as proportion of participants with SVR ≥ 35% by MRI (preferred) or CT (if MRI is contraindicated and if CT is allowed by local guidelines) assessed by BICR [ Time Frame: Up to 175 days ]
  3. SVR at end of Cycle 3 and 6 assessed by BICR [ Time Frame: Up to 175 days ]
  4. Response rate defined as proportion of participants with SVR ≥ 25% by MRI (preferred) or CT (if MRI is contraindicated and if CT is allowed by local guidelines) assessed by BICR [ Time Frame: Up to 175 days ]
  5. Symptom response rate (SRR) based on total symptom score (TSS) measured by Myelofibrosis Symptom Assessment Form (MFSAF) [ Time Frame: Up to 175 days ]
  6. Additional measures based on TSS measured by MFSAF [ Time Frame: Up to 175 days ]
  7. For transfusion independent (TI), proportion of participants having ≥ 2.0 g/dL hemoglobin (Hgb) increase over baseline [ Time Frame: Up to 24 months ]
  8. 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 ]
  9. For transfusion dependent (TD), proportion of participants becoming Tl as measured by the absence of erythropoiesis stimulating agents (ESA) over any consecutive 12-week period [ Time Frame: Up to 24 months ]
  10. For transfusion dependent (TD), proportion of participants becoming Tl as measured by the absence of hydroxyurea over any consecutive 12-week period [ Time Frame: Up to 24 months ]
  11. Summary of plasma concentrations pharmacokinetics (PK) parameters: maximum observed concentration (Cmax) [ Time Frame: Up to 56 days ]
  12. Summary of plasma concentrations PK parameters: time of maximum observed concentration (Tmax) [ Time Frame: Up to 56 days ]
  13. Summary of plasma concentrations 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 ]
  14. 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)


  15. 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04817007


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04817007    
Other Study ID Numbers: CA011-023
2020-002071-35 ( EudraCT Number )
First Posted: March 25, 2021    Key Record Dates
Last Update Posted: March 12, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
BMS-986158
Fedratinib
Myelofibrosis
Ruxolitinib
Additional relevant MeSH terms:
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Primary Myelofibrosis
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases