9 completed, 8 recruiting, 3 active not recruiting. 11 Phase 1, 7 Phase 2, 3 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 11 | Completed 9, Active not recruiting 2 |
| Phase 2 | 7 | Recruiting 6, Active not recruiting 1 |
| Phase 3 | 3 | Recruiting 2, Active not recruiting 1 |
Follow ARQ531: new trials by email Literature Review of ARQ531 trials Research Report on ARQ531
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Nemtabrutinib and Lisocabtagene Maraleucel for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Nemtabrutinib, Lisocabtagene Maraleucel - Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | Phase 2 | Recruiting | Fred Hutchinson Cancer Center | 20 | 2026-12-01 | 2026-10-29 |
| Nemtabrutinib and Pembrolizumab for the Treatment of Richter Transformation, Diffuse Large B-cell Lymphoma Subtype Biospecimen Collection, Bone Marrow Biopsy, Computed Tomography - Richter Syndrome, Diffuse Large B-Cell Lymphoma | Phase 2 | Recruiting | Roswell Park Cancer Institute | 32 | 2026-11-15 | 2026-10-02 |
| Nemtabrutinib and Venetoclax for the Treatment of Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy - Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma | Phase 2 | Recruiting | Jennifer Woyach | 25 | 2026-11-01 | 2026-10-15 |
| Non-covalent BTK Inhibitor Nemtabrutinib in Combination With the CD20 Monoclonal Antibody Rituximab for the Treatment of Marginal Zone Lymphoma Biopsy Procedure, Biospecimen Collection, Bone Marrow Biopsy - Conjunctival Mucosa-Associated Lymphoid Tissue Lymphoma, Gastric Mucosa-Associated Lymphoid Tissue Lymphoma | Phase 2 | Recruiting | City of Hope Medical Center | 35 | 2026-10-23 | 2026-10-29 |
| A Study of the Effect of Diltiazem on the Plasma Levels of Nemtabrutinib (MK-1026-022) Nemtabrutinib, Diltiazem - Healthy | Phase 1 | Completed | Merck Sharp & Dohme LLC | 26 | 2025-12-08 | 2026-06-29 |
| Nemtabrutinib With Rituximab for the Treatment of Patients With Mantle Cell Lymphoma Biospecimen Collection, Bone Marrow Biopsy, Nemtabrutinib - Mantle Cell Lymphoma | Phase 2 | Recruiting | City of Hope Medical Center | 27 | 2025-01-22 | 2026-03-13 |
| A Study of Nemtabrutinib in Participants With Moderate Hepatic Impairment (MK-1026-015) Nemtabrutinib - Hepatic Impairment (HI) | Phase 1 | Completed | Merck Sharp & Dohme LLC | 24 | 2024-07-24 | 2026-09-02 |
| A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011) Nemtabrutinib, Ibrutinib, Acalabrutinib - Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma | Phase 3 | Recruiting | Merck Sharp & Dohme LLC | 1200 | 2023-12-13 | 2026-10-13 |
| A Study of the Effect of Nemtabrutinib (MK-1026) on the Plasma Levels of Digoxin in Healthy Participants (MK-1026-012) Digoxin, Nemtabrutinib - Healthy | Phase 1 | Completed | Merck Sharp & Dohme LLC | 24 | 2023-11-07 | 2024-10-03 |
| A Study of the Effects of Itraconazole on the Plasma Levels of Nemtabrutinib (MK-1026-013) Nemtabrutinib, Itraconazole - Healthy | Phase 1 | Completed | Merck Sharp & Dohme LLC | 15 | 2023-10-30 | 2024-11-14 |
| A Study to Evaluate the Effect of Food on Nemtabrutinib (MK-1026) in Healthy Participants (MK-1026-017) Nemtabrutinib - Healthy | Phase 1 | Completed | Merck Sharp & Dohme LLC | 20 | 2023-10-02 | 2025-01-14 |
| A Study to Compare Forms of Nemtabrutinib (MK-1026) in Healthy Adult Participants (MK-1026-007) Nemtabrutinib - Hematological Malignancy | Phase 1 | Completed | Merck Sharp & Dohme LLC | 40 | 2023-08-28 | 2024-09-19 |
| A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010). Nemtabrutinib, Venetoclax, Rituximab - Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Chronic Lymphocytic | Phase 3 | Recruiting | Merck Sharp & Dohme LLC | 735 | 2023-08-08 | 2026-11-06 |
| A Study of the Effect of Efavirenz on the Plasma Levels of Nemtabrutinib (MK-1026-014) Nemtabrutinib, Efavirenz - Healthy | Phase 1 | Completed | Merck Sharp & Dohme LLC | 16 | 2023-07-25 | 2024-11-20 |
| A Study to Evaluate the Effect of Food on Nemtabrutinib (MK-1026) in Healthy Participants (MK-1026-016) Nemtabrutinib - Healthy | Phase 1 | Completed | Merck Sharp & Dohme LLC | 18 | 2023-07-24 | 2025-01-14 |
| A Study of Nemtabrutinib vs Chemoimmunotherapy for Participants With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Without TP53 Aberrations (MK-1026-008, BELLWAVE-008) Nemtabrutinib, Fludarabine, Cyclophosphamide - Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma | Phase 3 | Active not recruiting | Merck Sharp & Dohme LLC | 300 | 2023-03-16 | 2026-03-16 |
| A Clinical Study of Nemtabrutinib in Japanese Participants With Hematological Malignancies (MK-1026-002) Nemtabrutinib - Mature B-cell Neoplasms | Phase 1 | Completed | Merck Sharp & Dohme LLC | 7 | 2023-02-13 | 2026-05-13 |
| A Study of Nemtabrutinib (MK-1026) in China Participants With Relapsed or Refractory Hematologic Malignancies (MK-1026-005) Nemtabrutinib - Hematological Malignancies | Phase 1 | Active not recruiting | Merck Sharp & Dohme LLC | 12 | 2022-06-09 | 2026-04-30 |
| Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003) Nemtabrutinib - Hematologic Malignancies, Waldenstroms Macroglobulinaemia | Phase 2 | Recruiting | Merck Sharp & Dohme LLC | 490 | 2021-04-05 | 2026-10-27 |
| A Study of Nemtabrutinib (MK-1026) in Participants With Relapsed or Refractory Hematologic Malignancies (ARQ 531-101/MK-1026-001) Nemtabrutinib - Lymphoma, B-Cell, Small Lymphocytic Lymphoma | Phase 1 / Phase 2 | Active not recruiting | ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) | 190 | 2017-06-26 | 2026-06-12 |
Leukemia, Lymphocytic, Chronic, B-Cell (7) · Hematologic Neoplasms (4) · Leukemia, B-Cell (2) · Lymphoma (2) · Lymphoma, B-Cell, Marginal Zone (2) · Lymphoma, Large B-Cell, Diffuse (2) · Lymphoma, Mantle-Cell (2) · Lymphoma, Non-Hodgkin (2) · Waldenstrom Macroglobulinemia (2) · Blood Protein Disorders (1) · Cardiovascular Diseases (1) · Dendritic Cell Sarcoma, Interdigitating (1) · Hemorrhagic Disorders (1) · Hemostatic Disorders (1) · Immune System Diseases (1)
Merck Sharp & Dohme LLC (14) · City of Hope Medical Center (2) · ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) (1) · Fred Hutchinson Cancer Center (1) · Jennifer Woyach (1) · Roswell Park Cancer Institute (1)
United States (18) · Australia (4) · Brazil (4) · China (4) · Turkey (Türkiye) (4) · Canada (3) · Chile (3) · Colombia (3) · Denmark (3) · Germany (3) · Israel (3) · Japan (3) · Mexico (3) · Poland (3) · South Africa (3)
Alexey V Danilov (1) · Geoffrey Shouse (1) · Jennifer A Woyach, MD (1) · Jennifer Huang, MD, PhD (1) · Matthew J Cortese (1)
PMID 34398557, PMID 37930156, PMID 41363770
P30CA033572 (2), 2023 (1)