NCT05406401

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Cyclophosphamide, Doxorubicin, and Prednisone Plus Rituximab or Rituximab Biosimilar (Truxima) (R-CHP) in Participants With Diffuse Large B-Cell Lymphoma (DLBCL) (MK-2140-007)

A Multicenter, Open-label, Phase 2 Dose Escalation and Confirmation, and Efficacy Expansion Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP in Participants With DLBCL (waveLINE)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study consists of a dose escalation/confirmation phase and an efficacy expansion phase. The dose escalation/confirmation phase is to determine the safety and tolerability and establish a preliminary recommended Phase 2 dose (RP2D) of zilovertamab vedotin when administered in combination with R-CHP in participants with DLBCL who have received no prior treatment for their disease. The efficacy expansion phase is to determine the efficacy of the RP2D of zilovertamab vedotin when administered in combination with R-CHP in participants with DLBCL who have received no prior treatment for their disease.

Conditions

• Lymphoma, Large B-Cell, Diffuse (DLBCL)

Interventions

Type	Name	Description
BIOLOGICAL	Zilovertamab Vedotin	IV infusion
DRUG	Cyclophosphamide	IV infusion
DRUG	Doxorubicin	IV infusion
BIOLOGICAL	Rituximab	IV infusion
BIOLOGICAL	Rituximab Biosimilar	IV infusion
DRUG	Prednisone	IV or oral administration (per local guidelines)
DRUG	Prednisolone	IV or oral administration (per local guidelines)

Timeline

• Start date: 2022-07-14
• Primary completion: 2029-04-26
• Completion: 2029-04-26
• First posted: 2022-06-06
• Last updated: 2024-10-15

Locations

22 sites across 7 countries: Canada, Israel, Italy, Poland, South Korea, Spain, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study