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).
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nemtabrutinib | Other / unclassified | 5 mg | Oral |
| Subject | Nemtabrutinib | Other / unclassified | 20 mg | Oral |
| Subject | Nemtabrutinib | Other / unclassified | 45 mg | Oral |
| Subject | Nemtabrutinib | Other / unclassified | 65 mg | Oral |
| Comparator | Rituximab | Monoclonal antibody | 100 mg | Intravenous |
| Comparator | Rituximab | Monoclonal antibody | 500 mg | Intravenous |
| Subject | Venetoclax | Small molecule | 10 mg | Oral |
| Subject | Venetoclax | Small molecule | 50 mg | Oral |
| Subject | Venetoclax | Small molecule | 100 mg | Oral |