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

Is NCT04728893 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Nemtabrutinib for hematologic malignancies.

Phase 2RecruitingMerck Sharp & Dohme LLCNCT04728893Data as of May 2026

Treatment: NemtabrutinibThe 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).

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Non-Hodgkin Lymphoma

Multiple Myeloma

Myelodysplastic Syndrome

Chronic Lymphocytic Leukemia

Biomarker criteria

Required: TP53 mutation

CLL/SLL participants with 17p deletion or tumor protein p53 (TP53) mutation who are relapsed or refractory following at least 1 line of prior therapy

Required: CCND1 overexpression

Mantle-cell lymphoma (MCL), documented by either overexpression of cyclin D1 or t (11;14)

Required: IGH t(11;14)

Mantle-cell lymphoma (MCL), documented by either overexpression of cyclin D1 or t (11;14)

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Must have received: covalent irreversible BTK inhibitor — relapsed or refractory

relapsed or refractory to prior therapy with a covalent, irreversible Bruton's tyrosine kinase inhibitor (BTKi)

Must have received: BCL2 inhibitor — relapsed or refractory

relapsed or refractory to prior therapy with a ... B-cell lymphoma 2 inhibitor (BCL2i)

Must have received: PI3K inhibitor — failed, intolerant, or ineligible

must have received and failed, been intolerant to, or determined by their treating physician to be a poor phosphoinositide 3-kinase inhibitor (PI3Ki) candidate or ineligible for a PI3Ki per local guidelines

Must have received: chemoimmunotherapy — relapsed or refractory

relapsed or are refractory to chemoimmunotherapy

Must have received: anti-CD20-based regimen — relapsed or refractory

relapsed or refractory to at least one prior line of systemic therapy including an anti-CD20-based regimen

Must have received: immunomodulatory agent (lenalidomide) — relapsed or refractory

relapsed or refractory to chemoimmunotherapy and immunomodulatory agents (such as lenalidomide based regimen)

Cannot have received: systemic anti-cancer therapy

Has received prior systemic anti-cancer therapy within 5 half-lives or 4 weeks (if prior therapy was a monoclonal antibody) before C1D1

Lab requirements

Blood counts

adequate organ function

Kidney function

adequate organ function

Liver function

adequate organ function

Has adequate organ function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Highlands Oncology Group ( Site 2728) · Springdale, Arkansas
  • University of California San Diego Moores Cancer Center ( Site 2717) · La Jolla, California
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA-Hematology and Medical Oncology ( Site 2724) · Torrance, California
  • Colorado Blood Cancer Institute ( Site 2726) · Denver, Colorado
  • The University of Louisville, James Graham Brown Cancer Center ( Site 2729) · Louisville, Kentucky

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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