drugset
drugset / Trial / 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)

NCT05406401 ↗

Phase 2 Active not recruiting 60 enrolled Merck Sharp & Dohme LLC
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2022-07-14
Primary completion
2029-04-26
Completion
2029-04-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Zilovertamab vedotin Unknown 1.5 mg/kg Intravenous
Subject Zilovertamab vedotin Unknown 2.5 mg/kg Intravenous
Background Cyclophosphamide Other / unclassified 750 mg/m2 Intravenous
Background Doxorubicin Other / unclassified 50 mg/m2 Intravenous
Background Prednisolone Other / unclassified 100 mg Intravenous
Background Prednisone Other / unclassified 100 mg Intravenous
Background Rituximab Monoclonal antibody 375 mg/m2 Intravenous

Indications

diffuse large B-cell lymphoma