A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010)
NCT06717347 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1046
Last updated 2026-05-22
Summary
The purpose of this study is to evaluate if zilovertamab vedotin with standard treatment can help people live longer without the cancer growing or spreading than people who receive standard treatment alone.
Conditions
- Diffuse Large B-Cell Lymphoma
Interventions
- DRUG
-
Per Approved Product Label
- DRUG
-
Prednisolone
Oral administration
- DRUG
-
Vincristine
IV infusion
- DRUG
-
Rescue medication
Participants receive rescue medication per approved product label. The rescue medication is granulocyte colony-stimulating factor (G-CSF).
- DRUG
-
Methylprednisolone
Per Approved Product Label
- DRUG
-
Doxorubicin
IV infusion
- BIOLOGICAL
-
Rituximab Biosimilar
IV infusion
- BIOLOGICAL
-
Zilovertamab vedotin
IV infusion
- BIOLOGICAL
-
IV infusion
- DRUG
-
IV infusion
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Medical Director · Merck Sharp & Dohme LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-27
- Primary Completion
- 2029-07-02
- Completion
- 2032-03-29
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Belgium
- Brazil
- Canada
- Chile
- China
- Colombia
- Denmark
- France
- Greece
- Guatemala
- Hong Kong
- Hungary
- Israel
- Italy
- Japan
- Malaysia
- Mexico
- Netherlands
- Peru
- Poland
- Portugal
- Puerto Rico
- Romania
- Singapore
- South Africa
- South Korea
- Spain
- Switzerland
- Taiwan
- Thailand
- Turkey (Türkiye)
- Ukraine
Study Locations
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