Trials / Recruiting
RecruitingNCT04728893
Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003)
A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants With Hematologic Malignancies
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 490 (estimated)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and efficacy of nemtabrutinib (formerly ARQ 531) in participants with hematologic malignancies of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Richter's transformation, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and Waldenström's macroglobulinemia (WM).
Detailed description
This study will be performed in 2 parts: Dose Escalation and Confirmation (Part 1) and Cohort Expansion (Part 2). Following determination of the recommended phase 2 dose (RP2D) in Part 1, the study plans to proceed with Part 2 using 8 disease-specific expansion cohorts (Cohorts A to H).
Conditions
- Hematologic Malignancies
- Waldenstroms Macroglobulinaemia
- Non-Hodgkins Lymphoma
- Chronic Lymphocytic Leukaemia
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nemtabrutinib | Nemtabrutinib tablets administered orally QD. |
Timeline
- Start date
- 2021-04-05
- Primary completion
- 2029-01-04
- Completion
- 2029-01-04
- First posted
- 2021-01-28
- Last updated
- 2026-04-13
Locations
121 sites across 22 countries: United States, Argentina, Australia, Brazil, Canada, China, Czechia, Denmark, France, Germany, Hungary, Ireland, Israel, Italy, Poland, Romania, South Korea, Spain, Switzerland, Turkey (Türkiye), Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04728893. Inclusion in this directory is not an endorsement.