Clinical trial of nemtabrutinib in adults with CLL or SLL

• Research type

  Research Study

• Full title

  A Phase 3, Randomized Study to Compare Nemtabrutinib Versus Comparator (Investigator’s Choice of Ibrutinib or Acalabrutinib) in Participants With Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BELLWAVE-011)

• IRAS ID

  1008561

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Research summary

  Researchers are looking for new ways to treat chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). CLL and SLL are types of blood cancer.

  Current treatments for CLL and SLL can slow cancer growth and help people to live longer. However, these treatments stop working for some people with CLL or SLL, and better treatments are needed.

  This is a clinical trial to compare nemtabrutinib (trial treatment) to ibrutinib or acalabrutinib (standard treatments). The goal of the trial is to learn if the cancer responds to treatment with nemtabrutinib as well as or better than treatment with ibrutinib or acalabrutinib. Researchers also want to learn if people who take nemtabrutinib live longer without the cancer getting worse than those who take standard treatments.

  About 1,200 people, aged 18 years or older, with CLL or SLL that have not received prior treatment will be in this trial.
  People will be assigned by equal chance to take either of these treatments by mouth:
  • Trial treatment: nemtabrutinib once a day
  • Standard treatment: ibrutinib once a day OR acalabrutinib twice a day

  Each person will take their assigned treatment until the cancer gets worse or they need to stop treatment.

  Each person could be in the trial for up to 9 years (possibly longer if they continue to benefit from treatment).

  During the trial, people will give blood, urine and possibly bone marrow samples. They will also have imaging tests, physical examinations and answer sets of questions about their health.

  People may or may not benefit from the treatment received during the trial. This trial has an external group of experts that will oversee the overall risk and benefit. If this group of experts decides that the trial treatment is not safe or does not show benefit, the trial can be stopped.

• REC name

  Wales REC 1

• REC reference

  23/WA/0257

• Date of REC Opinion

  30 Oct 2023

• REC opinion

  Further Information Favourable Opinion