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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: Recruiting Phase 2 study of Diffuse Large B Cell Lymphoma and DLBCL, sponsored by Merck Sharp & Dohme.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The CTCAE, Version 5.0 will be used to grade the severity of AEs in this study. DLTs will be reported for Part 1 of this study.
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 |
What NCT05139017 shows while recruiting
NCT05139017 is an interventional study that assigns participants to a tested intervention. The registered 290 participants enrollment target is mid-sized for trials with a published cap, above the 216-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (34% higher).
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 names 20 study sites across 13 states, led by 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.
Where NCT05139017's enrollment target sits among peer trials
290 20th of 114 higher than 95 of 114 other Diffuse Large B Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diffuse Large B Cell Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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