drugset / Trial / NCT05947851

A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010).

NCT05947851 ↗

Phase 3 Recruiting 735 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of this study is to assess the safety and tolerability and to confirm the dose of nemtabrutinib in combination with venetoclax in participants with R/R CLL/SLL. The primary study hypotheses are that the combination of nemtabrutinib plus venetoclax is superior to VR with respect to progression-free survival (PFS) per 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria as assessed by blinded independent central review (BICR).

Timeline

Start
2023-08-08
Primary completion
2032-06-01
Completion
2035-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Nemtabrutinib Other / unclassified — Oral
Comparator Rituximab Monoclonal antibody 500 mg/m2 Intravenous
Subject Venetoclax Small molecule 400 mg Oral