# BELLWAVE-011

Source: https://onco.cc/trials/bellwave-011/  
OnCo record `bellwave-011` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

BELLWAVE-011 is Merck's bid to enter frontline CLL with a reversible BTK inhibitor, head to head against two approved covalent drugs.

## Summary

BELLWAVE-011, trial NCT06136559 sponsored by Merck, is Merck's bid to enter frontline chronic lymphocytic leukaemia with the reversible BTK inhibitor nemtabrutinib, tested head to head against investigator's choice of ibrutinib or acalabrutinib in previously untreated disease. It is an open-label randomised phase 3 with progression-free survival as the primary endpoint and was recruiting in July 2026, while the companion BELLWAVE-008 compares nemtabrutinib with chemoimmunotherapy in patients without TP53 aberrations. OnCo links it to chronic lymphocytic leukaemia, BTK as a target, nemtabrutinib, ibrutinib and acalabrutinib. Whether a non-covalent inhibitor can beat the approved covalent drugs in the frontline, rather than only after them, is the question it will answer.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-07
- Registry id: NCT06136559
- Phase: 3
- Setting: Previously untreated CLL/SLL: nemtabrutinib vs investigator's choice of ibrutinib or acalabrutinib
- Sponsor: Merck

## Sources

- ClinicalTrials.gov NCT06136559: https://clinicaltrials.gov/study/NCT06136559

## Connected records

- cancers: [Chronic lymphocytic leukaemia](https://onco.cc/cancers/cll/), [Chronic lymphocytic leukaemia, first treatment](https://onco.cc/cancers/cll-treatment-naive/), [Relapsed or refractory chronic lymphocytic leukaemia](https://onco.cc/cancers/cll-relapsed/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [BTK (Bruton tyrosine kinase)](https://onco.cc/targets/btk/)
- drugs: [Acalabrutinib](https://onco.cc/drugs/acalabrutinib/), [Ibrutinib](https://onco.cc/drugs/ibrutinib/), [Nemtabrutinib](https://onco.cc/drugs/nemtabrutinib/)
- companies: [Merck & Co. (MSD)](https://onco.cc/companies/merck/)

---
JSON: https://onco.cc/api/v1/entities/bellwave-011.json