Phase 2 Study of MK-1026 in Participants with Hematologic Malignancies
Research type
Research Study
Full title
A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants with Hematologic Malignancies
IRAS ID
1003963
Contact name
Andrea Mooney
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
Eudract number
2020-002324-36
Clinicaltrials.gov Identifier
Research summary
This is a Phase 2 study to determine the efficacy and safety of MK-1026.
This study will be performed in 2 parts: Dose Escalation and Confirmation (Part 1) – administering dose levels of trial drug to determine a recommended dose, and Cohort Expansion (Part 2) – recommended dose researched on a larger number of patients within set groups.
Approximately 465 male and female participants at least 18 years of age will be in the trial (30 in Part 1 and 370 in Part 2). The part the participant is placed in will depend on when they joined the trial and the type of disease they have: Part 1 – Chronic lymphocytic leukaemia/ Small lymphocytic lymphoma (CLL/SLL); and Part 2 – CLL/SLL, Richter’s transformation, Mantle cell lymphoma (MCL), Marginal zone lymphoma (MZL), Follicular lymphoma (FL) and Waldenstrom’s macroglobulinaemia (WM). MK-1026 has not been approved to treat the cancer types in this trial.
All participants will receive MK-1026. In Part 1, 3 dose levels of MK-1026 will be evaluated. Data from Part 1 and previous studies will determine a recommended dose for participants. The study will proceed with Part 2 with participants in 8 cohorts receiving the MK-1026 recommended dose.
The participant will receive treatment 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 require approximately 6.5 years from the time the first participant agrees to take part until the last participant’s last-trial related contact.
The trial is sponsored by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (MSD).
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
21/NW/0266
Date of REC Opinion
26 Oct 2021
REC opinion
Further Information Favourable Opinion