What is zilovertamab vedotin studying for relapsed or refractory diffuse large B-cell lymphoma?

Zilovertamab vedotin is being studied in combination with standard treatments to evaluate its safety and effectiveness for people with relapsed or refractory diffuse large B-cell lymphoma. Researchers want to see if adding this drug improves progression-free survival compared to standard care alone. The trial is sponsored by Merck Sharp & Dohme LLC.

Who may be eligible for this diffuse large B-cell lymphoma clinical trial?

Adults aged 18 and older diagnosed with relapsed or refractory diffuse large B-cell lymphoma who have failed or are ineligible for autologous stem-cell transplant may be eligible. Participants should have an ECOG performance status of 0 to 2 and adequate organ function. Please review eligibility criteria for more details.

Is there any cost to participate in this diffuse large B-cell lymphoma clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any costs outside of study-provided care.

Actively Recruiting

Phase 2

Phase 3

Age: 18Years +

All Genders

ID05139017

Phase 23 Study of Zilovertamab Vedotin with Standard Treatments for Relapsed or Refractory Diffuse Large B-Cell Lymphoma rrDLBCL

Led by Merck Sharp & Dohme LLC · Updated on 2026-08-07

290

Participants Needed

135

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of zilovertamab vedotin ZV combined with standard treatments for people with relapsed or refractory diffuse large B-cell lymphoma rrDLBCL. This Phase 23 study is divided into two parts Dose Confirmation and Efficacy Expansion. It aims to compare ZV combined with rituximab, gemcitabine, and oxaliplatin R-GemOx against R-GemOx alone, and ZV combined with bendamustine rituximab BR against BR alone, focusing on progression-free survival. Enrollment in the BR-related arms has been discontinued with no analysis planned for those arms.

CONDITIONS

Brief Title

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)

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Diagnosed with diffuse large B-cell lymphoma (DLBCL) confirmed by tissue analysis
Has measurable lymphoma based on imaging following Lugano criteria
Has an ECOG performance status of 0 to 2 within 7 days before treatment
Has adequate organ function
Able to provide a new or archival tumor tissue sample not previously irradiated
For ZV plus R-GemOx or R-GemOx arms: relapsed or refractory DLBCL, ineligible for or failed autologous stem-cell transplant, failed at least 1 prior therapy line
Has post-CAR-T cell therapy failure or is ineligible for CAR-T therapy

You will not qualify if you...

History of transformation from indolent disease to DLBCL (no longer applicable per protocol amendment 4)
Received any solid organ transplant
Diagnosed with primary mediastinal B-cell lymphoma
Has active significant cardiovascular disease or serious arrhythmia needing medication
Has ongoing graft-versus-host disease or is receiving treatment for it
Has clinically significant pericardial or pleural effusion
Has ongoing peripheral neuropathy greater than Grade 1
History of a second cancer unless treated curatively with no evidence for 2 years
Has a demyelinating form of Charcot-Marie-Tooth disease
Contraindication to any study drug components including prior severe allergic reaction
Received systemic anticancer therapy or investigational agents within 4 weeks before study
Received radiotherapy within 4 weeks before study and not fully recovered
On ongoing corticosteroid therapy
Received live or live-attenuated vaccine within 30 days before study
Participated in another investigational drug or device study within 4 weeks before study
Has active central nervous system lymphoma involvement; prior CNS disease must be in remission
Has an active infection requiring systemic treatment
Known history of HIV infection
Known active Hepatitis C infection
Psychiatric or substance abuse disorder interfering with study cooperation

Research Team

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Phase 23 Study of Zilovertamab Vedotin with Standard Treatments for Relapsed or Refractory Diffuse Large B-Cell Lymphoma rrDLBCL

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria