Zilovertamab vedotin (MK-2140) plus R-CHP in people with the GCB DLBCL
Research type
Research Study
Full title
A Randomized, Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Zilovertamab Vedotin (MK-2140) Plus R-CHP Versus Polatuzumab Vedotin Plus R-CHP in Treatment-naïve Participants With GCB Subtype of Diffuse Large B-cell Lymphoma (DLBCL)
IRAS ID
1011281
Contact name
- -
Contact email
-
Sponsor organisation
Merck Sharp & Dohme LLC
Clinicaltrials.gov Identifier
Research summary
Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. B-cells are a type of white blood cell that makes antibodies (proteins) that help fight infections. GCB is a type of DLBCL that affects young B-cells that are still maturing.\nR-CHP is a standard (usual) treatment for DLBCL, and includes:\n•\tChemotherapy - medicine that destroys cancer cells or stops them from growing\n•\tImmunotherapy - medicine that helps the immune system to fight cancer\n•\tSteroids - medicines that lower inflammation (swelling)\nPolatuzumab vedotin is an antibody-drug conjugate (ADC), a drug that attaches to a protein on cancer cells and delivers treatment to destroy those cells. R-CHP may be given with polatuzumab vedotin to help treat patients with DLBCL.\nResearchers want to know if a study treatment, ZV (also called zilovertamab vedotin or MK-2140) given with R-CHP can treat GCB DLBCL. \nThe goal of this study is to learn if more people who receive ZV and R-CHP have the cancer go away than those who receive polatuzumab vedotin and R-CHP.\n\nAbout 594 people with GCB DLBCL, and 18 years of age and older will take part in this study. \n\nPeople will receive their treatments for up to about 4 months. \n\nResearchers will assign people by equal chance to 1 of the 2 groups:\n•\tGroup 1 will receive ZV and R-CHP\n•\tGroup 2 will receive polatuzumab vedotin and R-CHP\nThe people in the study and researchers will know which treatment a person is getting. People will give tumor tissue, blood and urine samples, and may have bone marrow biopsies. They will have heart tests, imaging tests, physical examinations, and answer questions about their health. People may be in this study for up to 5 and a half years.
REC name
London - London Bridge Research Ethics Committee
REC reference
25/LO/0111
Date of REC Opinion
2 May 2025
REC opinion
Further Information Favourable Opinion