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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)
NCT05139017 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 290 participants |
| Start Date | 2022-01-14 |
| Est. Completion | 2027-09-24 |
| Phase | Phase 2 |
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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 290 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05139017 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, Kentucky, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05139017?
The interventions under investigation include: Oxaliplatin (DRUG), Gemcitabine (DRUG), Rituximab (BIOLOGICAL), Zilovertamab vedotin (BIOLOGICAL), Bendamustine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05139017?
This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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