A Study of Nemtabrutinib (MK-1026) in Participants With Relapsed or Refractory Hematologic Malign… (NCT03162536) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Study of Nemtabrutinib (MK-1026) in Participants With Relapsed or Refractory Hematologic Malignancies (ARQ 531-101/MK-1026-001)
United States190 participantsStarted 2017-06-26
Plain-language summary
This study aims to evaluate the safety, tolerability, pharmacodynamic, and pharmacokinetic (PK) of nemtabrutinib (formerly ARQ 531) tablets in selected participants with relapsed or refractory hematologic malignancies. No formal hypothesis testing will be performed for this study.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
Each prospective participant must meet ALL of the following inclusion criteria in order to be eligible for this study:
* Signed written informed consent granted prior to initiation of any study-specific procedures
* For the dose escalation cohorts, relapsed or refractory (R/R) participants with a diagnosis of B-cell Non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) and Waldenstrom macroglobulinemia (WM) who have received at least two prior systemic therapies . Participants must have failed or are intolerant to standard therapies and cannot be a candidate for standard salvage regimens. Participants with low grade lymphoma must be progressing and requiring treatment
* For the expansion cohorts, the following criteria must be met:
* Cohort A: 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 Bruton's tyrosine kinase (BTK) mutation on C481 residue
* Cohort B: 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. In this study, intolerance to standard therapy is defined as having experienced a grade 3 or higher adverse event that was caused by the standard therapy and resulted in treatment discontinuation
* Cohort C: Richter's transformation (RT) participants who have failed at least one prior therapy
…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is in Phase 1/Phase 2 and the Phase 1 part is specifically measuring dose-limiting toxicities and adverse events for nemtabrutinib, what does that mean for how much is known about the drug's safety profile so far, and does that affect whether it might be right for me?
2The trial is listed as 'active, not recruiting' — does that mean I've already missed the chance to enroll, or are there related trials or expanded access options for nemtabrutinib that my care team could explore?
3My condition is one of the ones listed — like CLL, mantle cell lymphoma, or follicular lymphoma — but the trial has separate cohorts for different diagnoses; which cohort would have applied to me, and does the response rate data from that specific group tell us anything useful about whether this approach makes sense for my situation?
4Since this drug is a BTK inhibitor being tested in people whose cancer came back or stopped responding to prior treatment, how does it compare to other approved BTK inhibitors or standard second-line options that are already available to me?
5What does 'objective response rate' as the main thing being measured in Phase 2 actually mean in practical terms — does a response in that sense translate to a meaningful benefit for how I feel or how long my remission might last?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase 1: Number of Participants Experiencing Dose Limiting Toxicity (DLT)
Timeframe: Cycle 1 (up to 28 days)
2
Phase 1: Number of Participants Who Experienced an Adverse Event (AE)
Timeframe: Up to approximately 86 months
3
Phase 1: Number of Participants Who Discontinued Study Treatment Due to an AE
Timeframe: Up to approximately 86 months
4
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
5
Phase 2: Expansion Cohorts A, B, C: ORR per Lugano Classification as Assessed by the Investigator
Timeframe: Up to approximately 64 months
Trial details
NCT IDNCT03162536
SponsorArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)