About this trial
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).
This study will be performed in 2 parts: Dose Escalation and Confirmation (Part 1) and Cohort Expansion (Part 2). Following determination of the recommended phase 2 dose (RP2D) in Part 1, the study plans to proceed with Part 2 using 8 disease-specific expansion cohorts (Cohorts A to H).
Patient Profile
| Inclusion Criteria: Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days prior to allocation Has a life expectancy of at least 3 months, based on the investigator assessment Has the ability to swallow and retain oral medication Participants who are Hepatitis B surface antigen (HBsAg)-positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening Has adequate organ function Male participants agree to refrain from donating sperm and agree to either remain abstinent from penile-vaginal intercourse as their preferred and usual lifestyle OR agree to use contraception, during the intervention period and for at least the time required to eliminate the study intervention after last dose of study intervention Female participants assigned female sex at birth who are not pregnant or breastfeeding are eligible to participate if not a participant of childbearing potential (POCBP), or if a POCBP they either use a contraceptive method that is highly effective OR remain abstinent from penile-vaginal intercourse as their preferred and usual lifestyle during the intervention period and for at least 30 days after the last dose of study intervention Participants with HIV are eligible if they meet all of the following: the CD4 count is >350 cells/uL at screening, the HIV viral load is below the detectable level, are on a stable ART regimen for at least 4 weeks prior to study entry, and are compliant with their ART Part 1 and Part 2 (Cohorts A to C) Part 2 (Cohorts D to G) Has active disease defined as 1 of the following: systemic symptoms, physical findings, laboratory abnormalities, coexisting disease |
Where’s this trial being run?
Beaumont Hospital and University Hospital Limerick
Can I join this study / trial?
The first step we recommend is to talk to your doctor or the cancer trials team at your hospital. You can find contact details for cancer trials research units in Ireland here.
It’s also a good idea to print this page and bring it with you to your appointment. It can help guide the conversation and remind you of what to ask. You may also want to talk to your family or friends about your options, as they can offer support as you make decisions.
For more detailed information
Click HereQuestions?
Here’s a list of questions you may have for your doctor or local cancer research team.
QuestionsSummary Data
| Name: | MK-1026-003 |
|---|---|
| Number: | 21-22 |
| Full Title: | A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants With Hematologic Malignancies |
| Principal Investigator: | Prof Clifford |
|---|---|
| Type: | Industry Sponsored |
| Sponsor: | MSD |
| Recruitment Started: |
Global: 05-Apr-2021 Ireland: 08-Feb-2024 |
| Global Recruitment Target: | 420 |
|---|---|
| Ireland Recruitment Target: | 6 |