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Anti-tumor antibiotic

Zilovertamab Vedotin + Standard of Care for Diffuse Large B-Cell Lymphoma

Phase 2 & 3
Recruiting
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Is able to provide new or archival tumor tissue sample not previously irradiated
For Zilovertamab vedotin plus Bendamustine Rituximab (BR), and Bendamustine Rituximab study arms: Has post-CAR-T therapy failure or is ineligible for CAR-T cell therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~36 months
Awards & highlights

Study Summary

This trial is studying zilovertamab vedotin in combination with standard of care options for the treatment of rrDLBCL to see if it is more effective than standard of care alone.

Who is the study for?
Adults with relapsed or refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) who have measurable disease, an ECOG status of 0 to 2, and adequate organ function. They must have failed previous therapies and be able to provide a tumor tissue sample. Exclusions include those with certain medical conditions, recent treatments or vaccinations, active infections like HIV or Hepatitis C, significant heart issues, CNS lymphoma involvement, ongoing corticosteroid therapy, and other specific health concerns.Check my eligibility
What is being tested?
The trial is testing Zilovertamab Vedotin (ZV) combined with standard care options against just the standard care for rrDLBCL treatment. It's in two parts: first confirming the dose of ZV and then expanding to test its effectiveness. The goal is to see if adding ZV improves progression-free survival compared to the current treatments alone.See study design
What are the potential side effects?
Potential side effects may include reactions related to infusion such as fever or chills; nerve damage that could cause numbness or tingling; blood disorders leading to increased risk of infection or bleeding; digestive issues like nausea; fatigue; allergic responses; and possibly others depending on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can provide a new or stored tumor sample that hasn't been exposed to radiation.
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My previous CAR-T cell therapy did not work, or I am not eligible for it.
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My DLBCL is measurable by scans according to Lugano criteria.
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My DLBCL has returned or didn't respond to treatment, and I can't have or didn't benefit from a stem-cell transplant. I've tried at least one treatment before.
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My previous CAR-T cell therapy did not work, or I am not eligible for it.
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My DLBCL has returned or didn't respond to treatment, and I've tried at least 2 therapies.
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My organs are functioning well.
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I have been diagnosed with diffuse large B-cell lymphoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants who discontinued study treatment due to an AE
Number of participants who experienced an adverse event (AE)
Number of participants who experienced dose-limiting toxicities (DLTs) in Part 1
+1 more
Secondary outcome measures
Duration of response (DOR)
Objective response rate (ORR)
Overall survival (OS)

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: ZV + R-GemOx (Part 2)Experimental Treatment4 Interventions
Using the recommended Phase 2 dose (RP2D) dose of ZV plus R-GemOx from Part 1, participants will receive ZV plus R-GemOx given intravenously on Day 1 of repeated 21-day cycles. Treatment will continue for up to 6 cycles or until progressive disease or discontinuation.
Group II: ZV + R-GemOx (Part 1)Experimental Treatment4 Interventions
Participants in this arm will receive doses of ZV (from 1.5 mg/Kg up to 2.5 mg/Kg) plus Rituximab 375 mg/m^2, Gemcitabine 1000 mg/m^2 and Oxaliplatin 100 mg/m^2 (R-GemOx) given intravenously on Day 1 of repeated 21-day cycles. Treatment will continue for up to 6 cycles.
Group III: ZV + BR (Part 2)Experimental Treatment3 Interventions
Using RP2D from Part 1, participants will receive ZV plus Rituximab 375 mg/m^2, given intravenously on Day 1 and Bendamustine 90 mg/m^2 given intravenously on Day 1 and 2, of repeated 21-day cycles. Treatment will continue for up to 6 cycles or until progressive disease or discontinuation.
Group IV: ZV + BR (Part 1)Experimental Treatment3 Interventions
Participants in this arm will receive doses of ZV (from 1.5 mg/Kg up to 2.5 mg/Kg) plus Rituximab 375 mg/m^2, Bendamustine 90 mg/m^2 (BR) given intravenously on Day 1 and 2 of repeated 21-day cycles. Treatment will continue for up to 6 cycles.
Group V: R-GemOx (active control for Part 2)Active Control3 Interventions
Participants will receive R-GemOx given intravenously on Day 1 of repeated 21-day cycles. Treatment will continue for up to 6 cycles or until progressive disease or discontinuation.
Group VI: Bendamustine Rituximab (BR)Active Control2 Interventions
Participants will receive Rituximab 375 mg/m^2, given intravenously on Day 1 Bendamustine 90 mg/m^2 given intravenously on Day 1 and 2 of repeated 21-day cycles. Treatment will continue for up to 6 cycles or until progressive disease or discontinuation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zilovertamab vedotin
2019
Completed Phase 2
~200
Rituximab
1999
Completed Phase 4
~1880
Gemcitabine
2017
Completed Phase 3
~2070
Oxaliplatin
2011
Completed Phase 4
~2560
Bendamustine
2015
Completed Phase 3
~2950

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,400 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,869 Previous Clinical Trials
5,051,489 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,770 Previous Clinical Trials
8,061,841 Total Patients Enrolled

Media Library

Bendamustine (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05139017 — Phase 2 & 3
Non-Hodgkin's Lymphoma Research Study Groups: ZV + R-GemOx (Part 1), ZV + R-GemOx (Part 2), R-GemOx (active control for Part 2), ZV + BR (Part 2), Bendamustine Rituximab (BR), ZV + BR (Part 1)
Non-Hodgkin's Lymphoma Clinical Trial 2023: Bendamustine Highlights & Side Effects. Trial Name: NCT05139017 — Phase 2 & 3
Bendamustine (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05139017 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial easy to find in major metropolitan areas?

"This trial is taking place at Louisiana State University Health Sciences Center New Orleans ( Site 0134) in Louisville, Louisiana, University of Massachusetts Medical School ( Site 0119) in New Orleans, Massachusetts, and New york Medical College ( Site 0113) in Worcester, New York along with 7 other locations."

Answered by AI

What are the main diseases that Zilovertamab vedotin has been shown to be effective against?

"While zilovertamab vedotin is most often used as a dlbcl treatment, it has also shown efficacy in treating small cell lung cancer (sclc), head and neck carcinoma, and cervical cancers."

Answered by AI

What is the efficacy of Zilovertamab vedotin in relation to other similar treatments?

"Zilovertamab vedotin was first studied at National Institutes of Health Clinical Center in 1993. So far, 2185 clinical trials have been completed, with 1197 active trials currently underway. Many of these trials are based in Louisville, Louisiana."

Answered by AI

Are there any vacancies in this research project for new participants?

"The most recent information from clinicaltrials.gov suggests that this clinical trial is still looking for patients. The trial was initially posted on January 14th, 2022 and was last updated on October 24th, 2022."

Answered by AI

How many participants are expected to join this research initiative?

"Yes, this is an ongoing study that is looking for 420 participants from 7 different locations. The trial was first announced on January 14th, 2022 and has since been updated on October 24th, 2022."

Answered by AI
~179 spots leftby Dec 2025