Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003)

Part of paid clinical trials in Springdale, Arkansas.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT04728893
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Lymphocytic Leukaemia
  • Hematologic Malignancies
  • Non-Hodgkins Lymphoma
  • Waldenstroms Macroglobulinaemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nemtabrutinib — DRUG
    Nemtabrutinib tablets administered orally QD.

Study Details

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).

Key Dates

Start date
Apr 5, 2021
Status verified
May 2026
Primary completion
Jan 4, 2029
Completion
Jan 4, 2029

Study Design

Enrollment
490 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nemtabrutinib
    Participants receive nemtabrutinib orally once daily (QD) until progressive disease (PD) or discontinuation.

Primary Outcome Measure

Part 1: Number of participants experiencing dose-limiting toxicities (DLTs) [ Time Frame: Up to ~56 days (Cycles 1-2, cycle = 28 days) ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Highlands Oncology Group ( Site 2728)SpringdaleArkansas72762
Study Coordinator
479-872-8130
University of California San Diego Moores Cancer Center ( Site 2717)La JollaCalifornia92093-0698
Study Coordinator
858-534-5201
Lundquist Institute for Biomedical Innovation at Harbor-UCLA-Hematology and Medical Oncology ( Site 2724)TorranceCalifornia90502-
Colorado Blood Cancer Institute ( Site 2726)DenverColorado80218
Study Coordinator
720-754-4800
The University of Louisville, James Graham Brown Cancer Center ( Site 2729)LouisvilleKentucky40202-
Mayo Clinic - Rochester ( Site 2706)RochesterMinnesota55905-
Astera Cancer Care ( Site 2732)East BrunswickNew Jersey08816
Study Coordinator
732-672-6405
John Theurer Cancer Center at Hackensack University Medical Center ( Site 2704)HackensackNew Jersey07601
Study Coordinator
551-996-3003
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 2708)FargoNorth Dakota58102-
UT Southwestern-Harold C. Simmons Cancer Center ( Site 2730)DallasTexas75390
Study Coordinator
972-695-9450
Medical Oncology Associates (Summit Cancer Centers) ( Site 2710)SpokaneWashington99208
Study Coordinator
509-462-2273

Find similar trials in Springdale, AR

By research site
Highlands Oncology Group· Springdale, ARUniversity of California San Diego Moores Cancer Center· La Jolla, CALundquist Institute for Biomedical Innovation at Harbor-UCLA-Hematology and Medical Oncology· Torrance, CAColorado Blood Cancer Institute· Denver, COThe University of Louisville, James Graham Brown Cancer Center· Louisville, KYMayo Clinic - Rochester· Rochester, MN

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