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BELLWAVE-011 is Merck's bid to enter frontline CLL with a reversible BTK inhibitor, head to head against two approved covalent drugs.
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.
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
Shares Acalabrutinib, Relapsed or refractory chronic lymphocytic leukaemia, Ibrutinib, Chronic lymphocytic leukaemia.
Shares Nemtabrutinib, Chronic lymphocytic leukaemia, Merck & Co. (MSD), Small-molecule kinase inhibitors.
Shares Nemtabrutinib, Chronic lymphocytic leukaemia, first treatment, Chronic lymphocytic leukaemia, Merck & Co. (MSD).
Shares Nemtabrutinib, Relapsed or refractory chronic lymphocytic leukaemia, Chronic lymphocytic leukaemia, Merck & Co. (MSD).
Shares Acalabrutinib, Relapsed or refractory chronic lymphocytic leukaemia, Chronic lymphocytic leukaemia, Small-molecule kinase inhibitors.
Shares Acalabrutinib, Chronic lymphocytic leukaemia, first treatment, Ibrutinib, Chronic lymphocytic leukaemia.
Shares Acalabrutinib, BTK (Bruton tyrosine kinase), Chronic lymphocytic leukaemia, first treatment, Chronic lymphocytic leukaemia.
Shares Chronic lymphocytic leukaemia, first treatment, Ibrutinib, Chronic lymphocytic leukaemia, Small-molecule kinase inhibitors.
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