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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%
Must not have
Has any clinically significant gastrointestinal abnormalities that might alter absorption
Has active central nervous system (CNS) disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~71 months
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I can swallow and keep down pills.
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My cancer can be measured by a scan, or I have high IgM levels, or 10% of my bone marrow is affected.
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My CLL/SLL is active and needs treatment.
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I have symptoms or signs that my disease is currently active.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have stomach or intestine problems that could affect how my body absorbs medicine.
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I have an active brain or spinal cord disease.
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I have a history of severe bleeding disorders.
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I am currently being treated for an infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~71 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~71 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 more
Secondary study objectives
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 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: NemtabrutinibExperimental Treatment1 Intervention
Participants receive nemtabrutinib orally once daily (QD) until progressive disease (PD) or discontinuation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nemtabrutinib
2023
Completed Phase 1
~100

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,972 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
4,015 Previous Clinical Trials
5,185,843 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,889 Previous Clinical Trials
8,088,703 Total Patients Enrolled

Media Library

Nemtabrutinib (BTK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04728893 — Phase 2
Blood Cancers Research Study Groups: Nemtabrutinib
Blood Cancers Clinical Trial 2023: Nemtabrutinib Highlights & Side Effects. Trial Name: NCT04728893 — Phase 2
Nemtabrutinib (BTK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04728893 — Phase 2
~186 spots leftby Mar 2027
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