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BTK Inhibitor
Nemtabrutinib for Blood Cancers
Phase 1 & 2
Waitlist Available
Research Sponsored by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Ability to swallow oral medications without difficulty
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 86 months
Awards & highlights
Study Summary
This trial will evaluate the safety and effectiveness of a new drug, nemtabrutinib, for people with relapsed or refractory hematologic malignancies.
Who is the study for?
This trial is for adults with certain blood cancers like lymphoma and leukemia that have come back or didn't respond to treatment. They must have tried at least two other treatments, be able to take pills, and not be eligible for standard therapies. Pregnant women, those with serious health issues, recent heart attacks, active infections or a history of cancer within the last year (with some exceptions) can't join.Check my eligibility
What is being tested?
The study tests Nemtabrutinib tablets in patients with relapsed or refractory hematologic malignancies. It looks at how safe and tolerable the drug is, as well as its effects on the body and how it's processed by measuring various parameters over time without comparing it to another treatment.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones may include nausea, fatigue, diarrhea; rare but more severe could involve liver problems or allergic reactions. The trial will closely monitor participants for any adverse reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of the day.
Select...
I can take pills without any trouble.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 86 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 86 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1: Number of Participants Experiencing Dose Limiting Toxicity (DLT)
Phase 1: Number of Participants Who Discontinued Study Treatment Due to an AE
Phase 1: Number of Participants Who Experienced an Adverse Event (AE)
+2 moreSecondary outcome measures
Area Under the Concentration-Time Curve From Time Zero to 24 Hours (AUC 0-24hrs)of Nemtabrutinib
Maximum Concentration (Cmax) of Nemtabrutinib
Phase 2: Expansion Cohorts A, B, H: Duration of Response (DOR) per iwCLL Criteria as Assessed by the Investigator
+7 moreTrial Design
10Treatment groups
Experimental Treatment
Group I: Phase 2: Expansion Food Effect Cohort IExperimental Treatment1 Intervention
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).
Group II: Phase 2: Expansion Cohort HExperimental Treatment1 Intervention
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).
Group III: Phase 2: Expansion Cohort GExperimental Treatment1 Intervention
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).
Group IV: Phase 2: Expansion Cohort FExperimental Treatment1 Intervention
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).
Group V: Phase 2: Expansion Cohort EExperimental Treatment1 Intervention
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).
Group VI: Phase 2: Expansion Cohort DExperimental Treatment1 Intervention
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).
Group VII: Phase 2: Expansion Cohort CExperimental Treatment1 Intervention
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).
Group VIII: Phase 2: Expansion Cohort BExperimental Treatment1 Intervention
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).
Group IX: Phase 2: Expansion Cohort AExperimental Treatment1 Intervention
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).
Group X: Phase 1: Dose Escalation and Determination of RP2DExperimental Treatment1 Intervention
Phase I: Dose Escalation and determination of RP2D, multiple dose levels of nemtabrutinib to be evaluated (Up to approximately 22 months).
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Who is running the clinical trial?
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)Lead Sponsor
36 Previous Clinical Trials
3,373 Total Patients Enrolled
1 Trials studying Lymphoma
120 Patients Enrolled for Lymphoma
ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)Lead Sponsor
36 Previous Clinical Trials
3,373 Total Patients Enrolled
1 Trials studying Lymphoma
120 Patients Enrolled for Lymphoma
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,290 Total Patients Enrolled
40 Trials studying Lymphoma
11,610 Patients Enrolled for Lymphoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking specific medications as listed.I have other serious health issues that could make the study drug unsafe for me.I do not have an active Hepatitis B or C infection.I do not have any health or mental conditions that could affect my safety or interfere with the study.I have not had cancer in the past year, except for certain skin or in situ cancers.I can take care of myself and am up and about more than half of the day.I have B-cell lymphoma or leukemia and standard treatments haven’t worked for me.My condition meets the specific disease status for CLL, B-cell NHL, or WM.My organs are functioning well.My cancer has spread to my brain or spinal cord.You have a heart condition that makes your electrocardiogram (ECG) show abnormal results.My follicular lymphoma has become more aggressive or is grade 3b.I can take pills without any trouble.I do not have any uncontrolled illnesses that would affect my participation in the study.I haven't had cancer treatments or experimental drugs within the last month.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2: Expansion Cohort C
- Group 2: Phase 2: Expansion Cohort A
- Group 3: Phase 2: Expansion Cohort B
- Group 4: Phase 2: Expansion Cohort G
- Group 5: Phase 1: Dose Escalation and Determination of RP2D
- Group 6: Phase 2: Expansion Food Effect Cohort I
- Group 7: Phase 2: Expansion Cohort E
- Group 8: Phase 2: Expansion Cohort F
- Group 9: Phase 2: Expansion Cohort H
- Group 10: Phase 2: Expansion Cohort D
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.
Are there any openings for people wishing to join this experiment?
"Clinicaltrials.gov confirms that this medical trial is not presently searching for participants, having been initially posted on June 26th 2017 and last edited September 2nd 2022. However, there are currently 5224 other studies actively recruiting patients at the moment."
Answered by AI
What aims is this medical trial attempting to achieve?
"The primary goal of this 24 week trial is to measure the number of participants who discontinued treatment due to an adverse event. Secondary objectives include determining the terminal elimination half-life, time to maximum concentration and area under the curve from zero up until twenty four hours for MK-1026 and Nemtabrutinib respectively."
Answered by AI
To what extent is this medical experiment being implemented in hospitals?
"The current research program is enrolling participants from 10 different sites, including Durham, Dallas and Scottsdale. To minimise travel burdens for the patient it may be beneficial to select a location close by."
Answered by AI
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