{"preliminary_commentary":{"by_channel":{"x_thread":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":[["nemtabrutinib"]],"indication":"relapsed or refractory hematologic malignancies","name":"NCT03162536","nct_id":"NCT03162536","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03162536. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Phase I: Dose Escalation and determination of RP2D, multiple dose levels of nemtabrutinib to be evaluated (Up to approximately 22 months).","label":"Phase 1: Dose Escalation and Determination of RP2D","type":"EXPERIMENTAL"},{"description":"Relapsed/Refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (R/R CLL/SLL) participants with at least 2 prior systemic therapies and previously treated with a covalent Bruton's tyrosine kinase inhibitor (BTKi) who must have a documented BTK mutation on C481 residue receive up to 65 mg of nemtabrutinib per day orally in each cycle (Cycle length = 28 days) until progressive disease (PD), unacceptable adverse events (AEs), or discontinuation at investigator's discretion (up to approximately 64 months).","label":"Phase 2: Expansion Cohort A","type":"EXPERIMENTAL"},{"description":"R/R CLL/SLL participants who have failed or were intolerant to a BTKi with documentation of the absence of BTK mutation on C481 residue receive up to 65 mg of nemtabrutinib per day orally in each cycle (Cycle length = 28 days) until PD, unacceptable AEs, or discontinuation at investigator's discretion (up to approximately 64 months).","label":"Phase 2: Expansion Cohort B","type":"EXPERIMENTAL"},{"description":"Richter's transformation (RT) participants who have failed at least one prior therapy receive up to 65 mg of nemtabrutinib per day orally in each cycle (Cycle length = 28 days) until PD, unacceptable AEs, or discontinuation at investigator's discretion (up to approximately 64 months).","label":"Phase 2: Expansion Cohort C","type":"EXPERIMENTAL"},{"description":"Follicular Lymphoma (FL) participants who have failed at least 2 prior systemic therapies and are histology grade 1, 2, or 3A receive up to 65 mg of nemtabrutinib per day orally in each cycle (Cycle length = 28 days) until PD, unacceptable AEs, or discontinuation at investigator's discretion (up to approximately 64 months).","label":"Phase 2: Expansion Cohort D","type":"EXPERIMENTAL"},{"description":"Mantle Cell Lymphoma (MCL) participants who have failed at least 2 prior systemic therapies receive up to 65 mg of nemtabrutinib per day orally in each cycle (Cycle length = 28 days) until PD, unacceptable AEs, or discontinuation at investigator's discretion (up to approximately 64 months).","label":"Phase 2: Expansion Cohort E","type":"EXPERIMENTAL"},{"description":"Marginal Zone Lymphoma (MZL) participants who have failed at least 2 prior systemic therapies receive up to 65 mg of nemtabrutinib per day orally in each cycle (Cycle length = 28 days) until PD, unacceptable AEs, or discontinuation at investigator's discretion (up to approximately 64 months).","label":"Phase 2: Expansion Cohort F","type":"EXPERIMENTAL"},{"description":"High-grade B-cell lymphoma (BCL) participants who have failed at least 2 prior systemic therapies and have known MYC and BCL2 and/or BCL6 translocations confirmed by flourescence in situ hybridization (FISH) or overexpression by immunohistochemistry (IHC) receive up to 65 mg of nemtabrutinib per day orally in each cycle (Cycle length = 28 days) until PD, unacceptable AEs, or discontinuation at investigator's discretion (up to approximately 64 months).","label":"Phase 2: Expansion Cohort G","type":"EXPERIMENTAL"},{"description":"Waldenström macroglobulinemia (WM) participants who have failed at least 2 prior systemic therapies receive up to 65 mg of nemtabrutinib per day orally in each cycle (Cycle length = 28 days) until PD, unacceptable AEs, or discontinuation at investigator's discretion (up to approximately 64 months).","label":"Phase 2: Expansion Cohort H","type":"EXPERIMENTAL"},{"description":"B-cell Non-Hodgkin's lymphoma (NHL), CLL/SLL and WM participants receive up to 65 mg of nemtabrutinib fasted (1 hour prior to or 2 hours after meal) and non-fasted per day orally in each cycle (Cycle length = 28 days) until PD, unacceptable AEs, or discontinuation at investigator's discretion (up to approximately 64 months).","label":"Phase 2: Expansion Food Effect Cohort I","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2027-09-17","type":"ESTIMATED"},"conditions":["Lymphoma, B-Cell","Small Lymphocytic Lymphoma","Chronic Lymphocytic Leukemia","Waldenstrom Macroglobulinemia","Mantle Cell Lymphoma","Diffuse Large B Cell Lymphoma","Richter's Transformation","Follicular Lymphoma","Marginal Zone Lymphoma"],"enrollment":{"count":190,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Nemtabrutinib","otherNames":["ARQ 531","MK-1026"],"type":"DRUG"}],"last_update":"2026-06-12","lead_sponsor":"ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)","official_title":"A Phase 1/2 Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of ARQ 531 in Selected Subjects With Relapsed or Refractory Hematologic Malignancies","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2027-09-17","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Phase 1: Number of Participants Experiencing Dose Limiting Toxicity (DLT)","timeFrame":"Cycle 1 (up to 28 days)"},{"measure":"Phase 1: Number of Participants Who Experienced an Adverse Event (AE)","timeFrame":"Up to approximately 86 months"},{"measure":"Phase 1: Number of Participants Who Discontinued Study Treatment Due to an AE","timeFrame":"Up to approximately 86 months"},{"measure":"Phase 2: Expansion Cohorts A, B & C: Objective Response Rate (ORR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria as Assessed by the Investigator","timeFrame":"Up to approximately 64 months"},{"measure":"Phase 2: Expansion Cohorts A, B, C: ORR per Lugano Classification as Assessed by the Investigator","timeFrame":"Up to approximately 64 months"}],"references":[{"citation":"Woyach JA, Stephens DM, Flinn IW, Bhat SA, Savage RE, Chai F, Eathiraj S, Reiff SD, Muhowski EM, Granlund L, Szuszkiewicz L, Wang W, Schwartz B, Ghori R, Farooqui MZH, Byrd JC. First-in-Human Study of the Reversible BTK Inhibitor Nemtabrutinib in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia and B-Cell Non-Hodgkin Lymphoma. Cancer Discov. 2024 Jan 12;14(1):66-75. doi: 10.1158/2159-8290.CD-23-0670.","pmid":"37930156","type":"RESULT"},{"citation":"Kipps TJ. Mining the Microenvironment for Therapeutic Targets in Chronic Lymphocytic Leukemia. Cancer J. 2021 Jul-Aug 01;27(4):306-313. doi: 10.1097/PPO.0000000000000536.","pmid":"34398557","type":"DERIVED"}],"start_date":{"date":"2017-06-26","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Nemtabrutinib (MK-1026) in Participants With Relapsed or Refractory Hematologic Malignancies (ARQ 531-101/MK-1026-001)","url":"https://clinicaltrials.gov/study/NCT03162536"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct03162536"}