MK-2140-006 Basket Study Exploring B-cell Malignancies
Research type
Research Study
Full title
A Multicenter, Open-label, Phase 2 Basket Study to Evaluate the Safety and Efficacy of MK-2140 as a Monotherapy and in Combination in Participants With Aggressive and Indolent B-cell Malignancies (waveLINE-006)
IRAS ID
1005610
Contact name
Uzor Ogbu
Contact email
Sponsor organisation
Merck Sharp & Dohme LLC
Eudract number
2021-004450-36
Clinicaltrials.gov Identifier
Research summary
The trial is testing zilovertamab vedotin (MK-2140) when given alone and when given with nemtabrutinib (MK-1026), in participants with certain types of B-cell lymphomas or leukaemia (B-cell cancers). For participants with Mantle Cell Lymphoma (MCL) or Richter Transformation (RT), the trial will be done in 1 part and has 3 groups. For participants with Follicular Lymphoma (FL) or Chronic Lymphocytic Leukaemia (CLL), the trial will be done in 2 parts and has 3 groups. The part the participant is placed in will depend on when they join the trial, the type of disease they have and how many treatments they have received in the past.
Following a screening period of up to 28 days, approximately 275 eligible male and female participants aged 18 years and over will take part in this trial.
Eligible participants will either receive cycles of Zilovertamab Vedotin or Zilovertamab Vedotin in combination with nemtabrutinib until their disease worsens, they experience bad side effects, they have an illness that requires them to stop taking the trial drug, or they leave the trial.
The Sponsor estimates that the trial will run for approximately 5 years and 6 months from the time the first participant agrees to take part until the last trial related contact.
The trial is sponsored by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, New Jersey, USA (“MSD”).
REC name
London - Fulham Research Ethics Committee
REC reference
22/LO/0924
Date of REC Opinion
10 May 2023
REC opinion
Further Information Favourable Opinion