NCT06890884

A Clinical Study of Zilovertamab Vedotin (MK-2140) Plus Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Polatuzumab Vedotin Plus R-CHP in People With Diffuse Large B-cell Lymphoma (DLBCL) (MK-2140-011/waveLINE-011)

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 594 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. GCB is a type of DLBCL that affects young B-cells that are still maturing. The goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP.

Conditions

• Lymphoma, Large B-Cell, Diffuse

Interventions

Type	Name	Description
BIOLOGICAL	Zilovertamab vedotin	IV infusion
BIOLOGICAL	Rituximab	IV infusion
DRUG	Cyclophosphamide	IV infusion
DRUG	Doxorubicin	IV infusion
BIOLOGICAL	Rituximab Biosimilar	IV infusion
DRUG	Prednisone	Oral administration or IV infusion
DRUG	Prednisolone	Oral administration or IV infusion
BIOLOGICAL	Polatuzumab vedotin	IV infusion
DRUG	Rescue Medication	Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medication is Granulocyte Colony-Stimulating Factor (G-CSF).

Timeline

• Start date: 2025-04-11
• Primary completion: 2027-12-13
• Completion: 2032-12-16
• First posted: 2025-03-24
• Last updated: 2026-04-02

Locations

117 sites across 9 countries: United States, Belgium, Germany, Ireland, Israel, Italy, Japan, Poland, United Kingdom

Regulatory

• FDA-regulated drug study