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BTK Inhibitor
Nemtabrutinib for Blood Cancers
Phase 2
Recruiting
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has the ability to swallow and retain oral medication
Has measurable disease, satisfying any of the following: at least 1 lesion that can be accurately measured in at least 2 dimensions with spiral CT scan (minimum measurement must be >15 mm in the longest diameter or >10 mm in the short axis); IgM ≥450 mg/dL; or bone marrow infiltration of 10%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~78 months
Awards & highlights
Study Summary
This trial is testing a new drug, nemtabrutinib, for people with different types of blood cancer. The researchers want to see if it is safe and if it works for these types of cancer.
Who is the study for?
This trial is for adults with certain blood cancers like CLL, SLL, Richter's transformation, MZL, MCL, FL, and WM. They must have tried at least two prior therapies (for some conditions), be able to take oral meds, not be pregnant or breastfeeding if female and agree to use contraception if male. People can't join if they've had recent cancer treatments or investigational drugs within the last month or have severe gastrointestinal issues that affect medication absorption.Check my eligibility
What is being tested?
The trial tests Nemtabrutinib's effectiveness and safety in treating various hematologic malignancies. Participants will receive this oral medication to see how well it works against their specific type of blood cancer and what its impact is on their overall health status.See study design
What are the potential side effects?
While the exact side effects are not listed here, common ones for similar medications include nausea, diarrhea, fatigue, risk of infection due to a weakened immune system from both the disease and treatment itself. There may also be liver function changes and potential bleeding complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can swallow and keep down pills.
Select...
My cancer can be measured by a scan, or I have high IgM levels, or 10% of my bone marrow is affected.
Select...
My CLL/SLL is active and needs treatment.
Select...
I have symptoms or signs that my disease is currently active.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to ~78 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~78 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1: Number of participants discontinuing study treatment due to AEs
Part 1: Number of participants experiencing adverse events (AEs)
Part 1: Number of participants experiencing dose-limiting toxicities (DLTs)
+3 moreSecondary outcome measures
Part 1: Area Under the Curve (AUC) of Nemtabrutinib
Part 1: Duration of Response (DOR) per iwCLL criteria 2018 as assessed by ICR
Part 1: Maximum Concentration (Cmax) of Nemtabrutinib
+10 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: NemtabrutinibExperimental Treatment1 Intervention
Participants receive nemtabrutinib orally once daily (QD) until progressive disease (PD) or discontinuation.
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,833 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,888 Previous Clinical Trials
5,054,607 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,414 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can care for myself and am up and about more than half of my waking hours.I had Hepatitis C but my viral load is now undetectable.I have stomach or intestine problems that could affect how my body absorbs medicine.You have a current Hepatitis B or Hepatitis C infection.You have had a recent bone marrow or lymph node biopsy for testing.I am not pregnant or breastfeeding, and if I can have children, I use effective birth control or practice abstinence.I am Hepatitis B positive but have been on antiviral therapy for over 4 weeks with an undetectable viral load.My organs are functioning well.I am a male and agree to not donate sperm and either abstain from sex or use contraception during and after the study.If you have HIV, you can join the study if your CD4 count is above 350, your HIV viral load is very low, you've been taking the same HIV medication for at least 4 weeks, and you take your medication as prescribed.You have been diagnosed with and have not responded to previous treatment for Richter's transformation, Mantle Cell Lymphoma, Marginal Zone Lymphoma, Follicular Lymphoma, or Waldenstrom's Macroglobulinemia.I have CLL/SLL and have undergone at least 2 prior treatments.I have an active brain or spinal cord disease.I have had cancer treatment within the last 4 weeks.I can swallow and keep down pills.My cancer can be measured by a scan, or I have high IgM levels, or 10% of my bone marrow is affected.My CLL/SLL is active and needs treatment.I have a history of severe bleeding disorders.I had cancer less than 3 years ago, but it was either skin cancer treated with curative intent, early-stage prostate cancer, or a localized cancer that was removed.I am currently being treated for an infection.I have a lymph node biopsy or bone marrow sample for testing.I have symptoms or signs that my disease is currently active.
Research Study Groups:
This trial has the following groups:- Group 1: Nemtabrutinib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the federal government given its blessing to Nemtabrutinib?
"While there is some evidence that suggests Nemtabrutinib might be safe, as this is only a Phase 2 trial, more research needs to be done to support its efficacy."
Answered by AI
What are we hoping to learn from this research?
"The objective of this study, which will last for approximately 78 months, is to evaluate the response rate of patients taking MK-1026 using ORR per IWWM criteria 2014. Additionally, the secondary outcomes being measured include DOR per Lugano criteria 2014 and AUC/Cmax of MK-1026."
Answered by AI
How many study participants are part of this experiment?
"In order to run this study, we need 450 individuals that fit the pre-determined criteria. People located near The Ottawa Hospital (Site 0404) in Ontario or Jewish General Hospital (Site 0400) in Quebec are eligible to participate."
Answered by AI
Where can I find a list of all the places where this research is being conducted?
"Presently, there are 5 active trial sites for this study. They include The Ottawa Hospital (Site 0404), Jewish General Hospital (Site 0400) in Montreal, Tom Baker Cancer Centre (Site 0401), and 5 other locations."
Answered by AI
Are patients still being accepted into this program?
"The trial, which was originally posted on 4/5/2021 and subsequently edited on 11/11/2022, is looking for active participants. The information comes from clinicaltrials.gov."
Answered by AI
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