A Study of Zilovertamab Vedotin in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Trial Information
Eligibility
Locations
Next steps

Recruiting

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 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.

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	National Trial Reference Number	NCT05139017
	MSD Protocol ID	MK-2140-003
	Conditions	Diffuse Large B-Cell Lymphoma, DLBCL
	Age Range	18+
	Sex	ALL
	Trial Phase	2, 3
	Start Date End Date	2022-01-14 2027-09-24

Study Details

Patient Participation

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Conditions

Diffuse Large B-Cell Lymphoma, DLBCL

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Trial 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.

Trial 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.

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Trial Locations

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Clinicaltrials.gov Identifier

NCT05139017

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