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Trial purpose
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 enrol 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), enrolment 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.
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NATIONAL TRIAL REFERENCE NUMBER | NCT05139017 |
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Conditions | Diffuse Large B-Cell Lymphoma, DLBCL |
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Age Range | 18+ |
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Sex | All |
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Current trial phase | 2 |
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Trial start and end dates | [01-14-2022] [09-24-2027] |
About the trial
Eligibility
Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial. However, this information may be useful in starting a conversation with your doctor.
Conditions
Diffuse Large B-Cell Lymphoma, DLBCL
All patients who enroll in the trial will receive medication while on the study.
100% will receive zilovertimab vedotin along with chemoimmunotherapy in Part 1
54% will receive zilovertimab vedotin along with chemoimmunotherapy in Part 2
46% will receive chemoimmunotherapy alone in Part 2
Phase 2
In Phase 2 trials, researchers try to find out if a treatment works in about 100 to 500 participants – usually people who have the health condition the treatment is intended to treat. In vaccine trials, the participants are usually healthy. Phase 2 trials may happen in a doctor’s office, a clinic, or a hospital.
Phase 3
In Phase 3 trials, researchers try to find out if a treatment works in a large number of people, usually about 1,000 to 5,000 participants who have the health condition the treatment is intended to treat. In vaccine trials, the participants may be healthy or have diseases or conditions. Phase 3 trials may happen in a doctor’s office, a clinic, or a hospital.
Trial locations (0)
Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest trial site. Talk with a trial site member for more information.