Condition: DLBCL · Diffuse Large B-Cell Lymphoma · Sponsor: Merck Sharp & Dohme LLC
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.
This description comes directly from the study's public registry record.
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| Palo Verde Hematology/ Oncology Center, Ltd. ( Site 0175) | Glendale, Arizona, United States | Recruiting |
| Beverly Hills Cancer Center ( Site 0184) | Beverly Hills, California, United States | Recruiting |
| Bass Medical Group ( Site 0166) | Walnut Creek, California, United States | Recruiting |
| Innovative Clinical Research Institute ( Site 0122) | Whittier, California, United States | Completed |
| Boca Raton Regional Hospital- Lynn Cancer Institute ( Site 0163) | Boca Raton, Florida, United States | Recruiting |
| Clermont Oncology Center ( Site 0174) | Clermont, Florida, United States | Recruiting |
| BRP-Hialeah Hospital ( Site 0182) | Hialeah, Florida, United States | Recruiting |
| Illinois Cancer Specialists ( Site 8000) | Niles, Illinois, United States | Recruiting |
| Saint Elizabeth Medical Center Edgewood ( Site 0165) | Edgewood, Kentucky, United States | Recruiting |
| University of Kentucky Chandler Medical Center ( Site 0158) | Lexington, Kentucky, United States | Recruiting |
| Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0133) | Louisville, Kentucky, United States | Recruiting |
| University of Maryland ( Site 0123) | Baltimore, Maryland, United States | Active Not Recruiting |
+ 123 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05139017