Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003)

Titre officiel

A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants With Hematologic Malignancies

Sommaire:

L’objectif de cette étude est d’évaluer l’innocuité et l’efficacité du nemtabrutinib (anciennement ARQ 531) chez des participants atteints d’affections malignes hématologiques telles que la leucémie lymphocytaire chronique (LLC)/le petit lymphome lymphocytaire (PLL), la transformation de Richter, le lymphome de la zone marginale (LZM), le lymphome à cellules du manteau (LCM), le lymphome folliculaire (LF) et la macroglobulinémie de Waldenström (MW).

Description de l'essai

Primary Outcome:

• Part 1: Number of participants experiencing dose-limiting toxicities (DLTs)
• Part 1: Number of participants experiencing adverse events (AEs)
• Part 1: Number of participants discontinuing study treatment due to AEs
• Part 2: Objective Response Rate (ORR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria 2018 as assessed by independent central review (ICR)
• Part 2: ORR per Lugano criteria 2014 as assessed by ICR
• Part 2: ORR per International Workshop on Waldenström's Macroglobulinemia (IWWM) criteria 2014 as assessed by ICR

Secondary Outcome:

• Part 1: Area Under the Curve (AUC) of Nemtabrutinib
• Part 1: Minimum Concentration (Cmin) of Nemtabrutinib
• Part 1: Maximum Concentration (Cmax) of Nemtabrutinib
• Part 1: ORR per iwCLL criteria 2018 as assessed by ICR
• Part 1: Duration of Response (DOR) per iwCLL criteria 2018 as assessed by ICR
• Part 2: Number of participants experiencing AEs
• Part 2: Number of participants discontinuing study treatment due to AEs
• Part 2: AUC of Nemtabrutinib
• Part 2: Cmin of Nemtabrutinib
• Part 2: Cmax of Nemtabrutinib
• Part 2: DOR per iwCLL criteria 2018 as assessed by ICR
• Part 2: DOR per Lugano criteria 2014 as assessed by ICR
• Part 2: DOR per IWWM criteria 2014 as assessed by ICR

This study will be performed in 2 parts: Dose Escalation and Confirmation (Part 1) and Cohort Expansion (Part 2). Following determination of a 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).

Voir cet essai sur ClinicalTrials.gov