Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT05139017 · ClinicalTrials.gov registry record · Phase 2

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 study of Diffuse Large B Cell Lymphoma and DLBCL, sponsored by Merck Sharp & Dohme.

Recruiting
Registry status
Phase 2
Development phase
290
Enrollment target
20
Study locations

NCT05139017 is a Phase 2 study of Diffuse Large B Cell Lymphoma and DLBCL that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 290 participants, above the 216-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (34% higher). The trial reports 20 study locations across 13 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT05139017, a Phase 2 study of Diffuse Large B Cell Lymphoma and DLBCL, is actively recruiting participants, sponsored by Merck Sharp & Dohme.

RECRUITING
Registry status
Phase 2
Development phase
290 participants
Enrollment target
20
Study locations

Study 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 Studied

Diffuse Large B Cell Lymphoma DLBCL

Interventions

  • DRUG Oxaliplatin
  • DRUG Gemcitabine
  • BIOLOGICAL Rituximab
  • BIOLOGICAL Zilovertamab vedotin
  • DRUG Bendamustine

Study Locations (20)

Florida

  • Boca Raton Regional Hospital- Lynn Cancer Institute ( Site 0163) - Boca Raton
  • Clermont Oncology Center ( Site 0174) - Clermont
  • BRP-Hialeah Hospital ( Site 0182) - Hialeah

Kentucky

  • Saint Elizabeth Medical Center Edgewood ( Site 0165) - Edgewood
  • University of Kentucky Chandler Medical Center ( Site 0158) - Lexington
  • Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0133) - Louisville

California

  • Bass Medical Group ( Site 0166) - Walnut Creek
  • Innovative Clinical Research Institute ( Site 0122) - Whittier

Massachusetts

  • Dana-Farber Cancer Institute-Lymphoma ( Site 0111) - Boston
  • University of Massachusetts Medical School ( Site 0119) - Worcester

Nebraska

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0188) - Grand Island
  • Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0177) - Omaha

Arizona

  • Palo Verde Hematology/ Oncology Center, Ltd. ( Site 0175) - Glendale

Maryland

  • University of Maryland ( Site 0123) - Baltimore

Michigan

  • Corewell Health ( Site 0162) - Grand Rapids

Trial Details

FieldValue
Enrollment Target 290 participants
Start Date 2022-01-14
Est. Completion 2027-09-24
Phase Phase 2

Sponsor

Merck Sharp & Dohme

558 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05139017

The ClinicalTrials.gov registry entry for NCT05139017 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 290 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 216-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (34% higher). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Diffuse Large B Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Oxaliplatin is the first listed.

NCT05139017 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Florida, Kentucky, California.

Frequently Asked Questions

What is clinical trial NCT05139017 about?

NCT05139017 is a clinical study titled "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)". 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 Confi...

What is the current status of trial NCT05139017?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 290 participants. The study started on 2022-01-14. Estimated completion is 2027-09-24.

What conditions does trial NCT05139017 study?

This clinical trial studies the following conditions: Diffuse Large B Cell Lymphoma, DLBCL.

What interventions are being tested in trial NCT05139017?

The interventions under investigation include: Oxaliplatin (DRUG), Gemcitabine (DRUG), Rituximab (BIOLOGICAL), Zilovertamab vedotin (BIOLOGICAL), Bendamustine (DRUG).

Who is sponsoring clinical trial NCT05139017?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05139017 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Kentucky, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Diffuse Large B Cell Lymphoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Diffuse Large B Cell Lymphoma

All registered trials for this condition

DLBCL

All registered trials for this condition

Arizona

All trials with a study site in Arizona

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.