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)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Palo Verde Hematology/ Oncology Center, Ltd. ( Site 0175) — Glendale, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (135 Sites)
Showing the first 25 of 135 sites.
- Palo Verde Hematology/ Oncology Center, Ltd. ( Site 0175) — Glendale, Arizona
- Beverly Hills Cancer Center ( Site 0184) — Beverly Hills, California
- Bass Medical Group ( Site 0166) — Walnut Creek, California
- Innovative Clinical Research Institute ( Site 0122) — Whittier, California
- Boca Raton Regional Hospital- Lynn Cancer Institute ( Site 0163) — Boca Raton, Florida
- Clermont Oncology Center ( Site 0174) — Clermont, Florida
- BRP-Hialeah Hospital ( Site 0182) — Hialeah, Florida
- Illinois Cancer Specialists ( Site 8000) — Niles, Illinois
- Saint Elizabeth Medical Center Edgewood ( Site 0165) — Edgewood, Kentucky
- University of Kentucky Chandler Medical Center ( Site 0158) — Lexington, Kentucky
- Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0133) — Louisville, Kentucky
- University of Maryland ( Site 0123) — Baltimore, Maryland
- Dana-Farber Cancer Institute-Lymphoma ( Site 0111) — Boston, Massachusetts
- University of Massachusetts Medical School ( Site 0119) — Worcester, Massachusetts
- Corewell Health ( Site 0162) — Grand Rapids, Michigan
- St. Vincent Frontier Cancer Center-Research ( Site 0108) — Billings, Montana
- Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0188) — Grand Island, Nebraska
- Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0177) — Omaha, Nebraska
- Comprehensive Cancer Centers of Nevada ( Site 0168) — Las Vegas, Nevada
- Atlantic Health System ( Site 0116) — Morristown, New Jersey
- Presbyterian Rust Jorgensen Cancer ( Site 9506) — Rio Rancho, New Mexico
- New York Medical College ( Site 0113) — Valhalla, New York
- Alliance Cancer Specialists (ACS) ( Site 8001) — Horsham, Pennsylvania
- Tennessee Cancer Specialists ( Site 7000) — Knoxville, Tennessee
- Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center ( Site 0156) — Nashville, Tennessee
📞 Contact the Study Coordinator
Phone: (888) 577-8839
Email: Trialsites@msd.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in DLBCL
- A Study of Polatuzumab Vedotin, Rituximab and Dose Attenuated CHP in Older Patients With DLBCL — Rochester, New York
- First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma — Phoenix, Arizona
- A Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma — Rochester, New York
Explore by condition: All DLBCL clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.