Test of bomedemstat for polycythemia vera in adults
Official title: A Phase 2/3, Randomized, Open-label, Active-comparator-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Bomedemstat (MK-3543) Versus Best Available Therapy in Participants With Polycythemia Vera Who Have an Inadequate Response to or Are Intolerant to Hydroxyurea
Run by Merck Sharp & Dohme LLC · NCT07722611 · Data updated 2026-11-12
This study tests bomedemstat (MK-3543) to see if it helps people with polycythemia vera reach healthier blood counts compared with standard treatments.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 380 (estimated) |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Locations | 5 sites (Newark, Delaware and 4 other locations) |
| Status | Recruiting |
| Started | October 29, 2026 |
| Main results expected | June 25, 2032 |
| Study ends | November 30, 2032 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT07722611 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with confirmed polycythemia vera who have failed prior cytoreductive therapy and have not benefited sufficiently from hydroxyurea, with no significant splenomegaly.
✕Probably not a fit
Patients who do not respond to bomedemstat or who have contraindications or specific disease characteristics may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional trial compares bomedemstat to two standard PV therapies in adults who have not fully responded to prior cytoreductive treatment. Participants will be assigned to receive bomedemstat or the usual care options to see if the new drug can help control red blood cell levels and reduce PV-related health problems. The study includes phase 2 and phase 3 components to evaluate safety, effectiveness, and tolerability. Eligible patients have PV with specific blood and marrow criteria and have limited or no splenomegaly. Locations include sites in Delaware, Oregon, and Virginia.
Why it matters
Potential benefit: If successful, patients may achieve better blood counts and lower risk of PV-related complications.
How similar studies have gone: Previous approaches in PV with new therapies have shown mixed success; this trial explores a targeted therapy in a similar setting to potentially improve outcomes.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has confirmed local diagnosis of polycythemia vera (PV) per World Health Organization (WHO) diagnostic criteria for PV * Must have discontinued prior cytoreductive therapy for condition under study for protocol specified duration * Has failed at least one prior line of cytoreductive therapy to lower hematocrit * Has a history of inadequate response, resistance to, or intolerant to hydroxyurea (HU) per protocol specified criteria * Has no evidence of splenomegaly and no symptoms attributable to splenomegaly, including early satiety, left upper quadrant discomfort, or splenic pain * Has locally assessed bone marrow (BM) fibrosis score of Grade 0 or Grade 1 as per modified version of the European Consensus Criteria for Grading Myelofibrosis * Human Immunodeficiency Virus (HIV)-infected participants have well controlled HIV on antiretroviral therapy (ART) * Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load * Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable * Participants must be able to swallow oral medication and follow instructions for at home dosing of bomedemstat Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has history of any illness/impairment of gastrointestinal (GI) function that might interfere with drug absorption * Has evidence at the time of screening of increased risk of bleeding * Has history of malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Is currently receiving anticancer therapy * Has an active infection requiring systemic therapy * Has had major surgical procedure ≤4 weeks before first dose of study intervention or has not recovered from side effects of major surgical procedure
Where it's running
-
Medical Oncology Hematology Consultants (MOHC) ( Site 8002)
Newark, Delaware, United States Recruiting -
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8004)
Eugene, Oregon, United States Recruiting -
University of Virginia ( Site 5031)
Charlottesville, Virginia, United States Recruiting -
Princess Margaret Cancer Centre ( Site 4002)
Toronto, Ontario, Canada Recruiting -
Hadassah Medical Center ( Site 2604)
Jerusalem, Israel Recruiting
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.com
- Phone: 1-888-577-8839
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.