NCT05139017

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

A Phase 2/3 Multicenter, Open-label, Randomized, Active-Control Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (waveLINE-003)

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 290 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this Phase 2/3, randomized, multisite, open-label, dose confirmation, and expansion study is to evaluate the safety, and efficacy of zilovertamab vedotin (ZV) in combination with standard of care options for the treatment of rrDLBCL. This study will be divided into 2 parts: Dose Confirmation (Part 1) and Efficacy Expansion (Part 2) and will enroll participants who are at least 18 years of age with rrDLBCL. The hypotheses are: ZV in combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx) is superior to R-GemOx with respect to progression-free survival (PFS) per Lugano response criteria by blinded independent review committee (BICR); and that ZV in combination with bendamustine rituximab (BR) is superior to BR with respect to PFS per Lugano response criteria by BICR. With protocol amendment 4 (effective: 04-April-2024), enrollment in Cohort B (study arms Bendamustine Rituximab \[BR\] and ZV + BR) is discontinued. No efficacy outcome analysis and hypothesis testing will be conducted for Cohort B.

Conditions

• DLBCL
• Diffuse Large B-Cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	Zilovertamab vedotin	Intravenous (IV) Infusion 1.5 mg/kg, 1.75 mg/kg, 2.0 mg/kg, 2.25 mg/kg, 2.5 mg/kg
BIOLOGICAL	Rituximab	IV Infusion 375 mg/m\^2
DRUG	Gemcitabine	IV Infusion 1000 mg/m\^2
DRUG	Oxaliplatin	IV Infusion 100 mg/m\^2
DRUG	Bendamustine	IV Infusion 90 mg/m\^2
DRUG	Granulocyte Colony-Stimulating Factor (G-CSF)	Prophylactic G-CSF will be administered at each cycle of zilovertamab vedotin as per the institutional guidelines.

Timeline

• Start date: 2022-01-14
• Primary completion: 2027-09-24
• Completion: 2027-09-24
• First posted: 2021-12-01
• Last updated: 2026-04-07

Locations

120 sites across 25 countries: United States, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Costa Rica, France, Greece, Guatemala, Hong Kong, Israel, Italy, Japan, Mexico, New Zealand, Peru, Poland, South Korea, Thailand, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study