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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)
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Palo Verde Hematology/ Oncology Center, Ltd. ( Site 0175)
Glendale, Arizona, United States
Bass Medical Group ( Site 0166)
Walnut Creek, California, United States
Innovative Clinical Research Institute ( Site 0122)
Whittier, California, United States
Boca Raton Regional Hospital- Lynn Cancer Institute ( Site 0163)
Boca Raton, Florida, United States
Clermont Oncology Center ( Site 0174)
Clermont, Florida, United States
BRP-Hialeah Hospital ( Site 0182)
Hialeah, Florida, United States
Saint Elizabeth Medical Center Edgewood ( Site 0165)
Edgewood, Kentucky, United States
University of Kentucky Chandler Medical Center ( Site 0158)
Lexington, Kentucky, United States
Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0133)
Louisville, Kentucky, United States
University of Maryland ( Site 0123)
Baltimore, Maryland, United States
Start Date
January 14, 2022
Primary Completion Date
September 24, 2027
Completion Date
September 24, 2027
Last Updated
March 20, 2026
290
ESTIMATED participants
Zilovertamab vedotin
BIOLOGICAL
Rituximab
BIOLOGICAL
Gemcitabine
DRUG
Oxaliplatin
DRUG
Bendamustine
DRUG
Granulocyte Colony-Stimulating Factor (G-CSF)
DRUG
Lead Sponsor
Merck Sharp & Dohme LLC
NCT01804686
NCT05755087
Data Source & Attribution
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