A Clinical Study of Nemtabrutinib in Japanese Participants With Hematological Malignancies (MK-1026-002)

Merck Sharp & Dohme LLC7 enrolled

Overview

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of nemtabrutinib in Japanese participants with mature B-cell neoplasms.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mature B-cell Neoplasms

Interventions

NemtabrutinibDRUG

Nemtabrutinib tablets will be administered orally QD at dosage of 45 mg or 65 mg

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * Histologically confirmed B-cell malignancy: * Chronic lymphocytic leukemia (CLL) * Small lymphocytic lymphoma (SLL) * Waldenström's macroglobulinemia (WM), * Lymphoplasmacytic lymphoma (LPL) * Other B-cell neoplasm * Failed or intolerant to either at least 2 prior regimens given in combination or sequentially OR have received 1 prior Bruton's tyrosine kinase (BTK)-containing regimen when a BTK inhibitor is approved as first line therapy * Have the ability to swallow and retain oral medication * Is Japanese Exclusion Criteria: * Active Hepatitis B virus (HBV)/Hepatitis C virus (HCV) infection at study entry * History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years * Known history of human immunodeficiency virus (HIV) infection * Clinically significant gastrointestinal abnormalities that might alter absorption (eg, gastric bypass surgery, gastrectomy) * Underlying history of severe bleeding disorders * History or concurrent condition of pneumonitis/interstitial lung disease

Locations (7)

Nagoya University Hospital ( Site 0003)

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East ( Site 0002)

Kashiwa, Chiba, Japan

Kindai University Hospital ( Site 0006)

Sayama, Osaka, Japan

Chiba Cancer Center ( Site 0005)

Chiba, Japan

Outcomes

Primary Outcomes

Number of Participants who Experience Dose Limiting Toxicities (DLTs) per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0

A DLT consists of one or more of the following toxicities: Grade ≥3 nonhematologic toxicity with exception of Grade 3 nausea, vomiting, diarrhea, rash, fatigue, and uncontrolled hypertension; Grade 4 hematologic toxicity lasting \>7 days, Grade 4 platelet count decreased of any duration (with exceptions), or Grade 3 platelet count decreased with bleeding, or Grade 3 or higher febrile neutropenia of any duration; Grade 3 or Grade 4 nonhematologic laboratory abnormality, if values result in drug induced liver injury (DILI), or medical intervention is required, or the abnormality leads to hospitalization, or the abnormality persists for \>1 week (with exceptions); missing \>25% of nemtabrutinib doses as a result of drug-related AE(s); Grade 5 toxicity. Toxicities will be graded using NCI-CTCAE version 5.0 except hematologic toxicities in participants with chronic lymphocytic leukemia (CLL) assessed according to the International Workshop on CLL (iwCLL) criteria.

Time frame: Up to approximately 4 weeks

Number of Participants who Experience Adverse Events (AEs)

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Time frame: Up to approximately 38 months

Number of Participants Discontinuing Study Treatment due to AEs

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Time frame: Up to approximately 38 months

Secondary Outcomes

Area under the Curve (AUC) of Nemtabrutinib

AUC is the area under the curve of plasma concentration of nemtabrutinib. Blood samples collected at designated timepoints will be used to determine AUC.

Data from ClinicalTrials.gov

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