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)
Public ClinicalTrials.gov record NCT05139017. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05139017
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 290 participants
Conditions and interventions
Conditions
Interventions
- Zilovertamab vedotin Biological
- Rituximab Biological
- Gemcitabine Drug
- Oxaliplatin Drug
- Bendamustine Drug
- Granulocyte Colony-Stimulating Factor (G-CSF) Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 13, 2022
- Primary completion
- Sep 23, 2027
- Completion
- Sep 23, 2027
- Last update posted
- Sep 2, 2026
2022 – 2027
United States locations
- U.S. sites
- 26
- U.S. states
- 17
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Palo Verde Hematology/ Oncology Center, Ltd. ( Site 0175) | Glendale | Arizona | 85304 | Recruiting |
| Beverly Hills Cancer Center ( Site 0184) | Beverly Hills | California | 90211 | Active, not recruiting |
| Bass Medical Group ( Site 0166) | Walnut Creek | California | 94598 | Recruiting |
| Innovative Clinical Research Institute ( Site 0122) | Whittier | California | 90603 | Completed |
| Boca Raton Regional Hospital- Lynn Cancer Institute ( Site 0163) | Boca Raton | Florida | 33486 | Recruiting |
| Clermont Oncology Center ( Site 0174) | Clermont | Florida | 34711 | Recruiting |
| BRP-Hialeah Hospital ( Site 0182) | Hialeah | Florida | 33013 | Recruiting |
| Illinois Cancer Specialists ( Site 8000) | Niles | Illinois | 60714 | Recruiting |
| Saint Elizabeth Medical Center Edgewood ( Site 0165) | Edgewood | Kentucky | 41017 | Recruiting |
| University of Kentucky Chandler Medical Center ( Site 0158) | Lexington | Kentucky | 40536 | Recruiting |
| Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0133) | Louisville | Kentucky | 40207 | Recruiting |
| University of Maryland ( Site 0123) | Baltimore | Maryland | 21201 | Active, not recruiting |
| Dana-Farber Cancer Institute-Lymphoma ( Site 0111) | Boston | Massachusetts | 02215 | Active, not recruiting |
| University of Massachusetts Medical School ( Site 0119) | Worcester | Massachusetts | 01655 | Active, not recruiting |
| Corewell Health ( Site 0162) | Grand Rapids | Michigan | 49503 | Recruiting |
| St. Vincent Frontier Cancer Center-Research ( Site 0108) | Billings | Montana | 59102 | Recruiting |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0188) | Grand Island | Nebraska | 68803 | Recruiting |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0177) | Omaha | Nebraska | 68130 | Recruiting |
| Comprehensive Cancer Centers of Nevada ( Site 0168) | Las Vegas | Nevada | 89169 | Recruiting |
| Atlantic Health System ( Site 0116) | Morristown | New Jersey | 07960 | Completed |
| Presbyterian Rust Jorgensen Cancer ( Site 9506) | Rio Rancho | New Mexico | 87124 | Active, not recruiting |
| New York Medical College ( Site 0113) | Valhalla | New York | 10595 | Recruiting |
| Alliance Cancer Specialists (ACS) ( Site 8001) | Horsham | Pennsylvania | 19044 | Recruiting |
| Tennessee Cancer Specialists ( Site 7000) | Knoxville | Tennessee | 37909 | Recruiting |
| Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center ( Site 0156) | Nashville | Tennessee | 37232 | Completed |
| Blue Ridge Cancer Care ( Site 0169) | Roanoke | Virginia | 24014 | Active, not recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 109 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05139017, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 2, 2026 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05139017 live on ClinicalTrials.gov.