Study of Zilovertamab Vedotin with Standard Treatment for Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL)

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05139017

This clinical trial is testing a new drug, Zilovertamab Vedotin, combined with standard treatments to see if it can better control Diffuse Large B-Cell Lymphoma (DLBCL) that has returned or not responded to previous treatments. The study is for adults aged 18 and older.

Patient Parameters

Program Overview

The study aims to find out if adding Zilovertamab Vedotin (ZV) to standard treatments can improve outcomes for patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (rrDLBCL). It is divided into two parts: the first part confirms the best dose, and the second part tests how well the treatment works. Participants will be randomly assigned to receive either ZV with rituximab, gemcitabine, and oxaliplatin (R-GemOx) or the standard R-GemOx treatment. The study will compare how long patients live without the disease getting worse. Enrollment for the part of the study involving Bendamustine Rituximab (BR) has been stopped, and no further analysis will be done for that group.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL).
  • Cancer can be measured by scans according to specific criteria.
  • General health status allows participation, with a performance score between 0 and 2.
  • Adequate organ function.
  • Able to provide a tumor sample for analysis.

For Zilovertamab Vedotin plus R-GemOx, or R-GemOx study arms:

  • DLBCL has returned or not responded to treatment, and the patient is not eligible for or has not succeeded with a stem-cell transplant.
  • Has not succeeded with CAR-T cell therapy or is not eligible for it.

Exclusion Criteria

  • Has had a solid organ transplant.
  • Diagnosed with primary mediastinal B-cell lymphoma (PMBCL).
  • Has serious heart disease or irregular heartbeat needing medication.
  • Has ongoing graft-versus-host disease (GVHD) or is being treated for it.
  • Has fluid around the heart or lungs that is significant.
  • Has nerve damage greater than Grade 1.
  • Has had another cancer unless treated and cancer-free for 2 years.
  • Has a specific nerve disease called Charcot-Marie-Tooth disease.
  • Allergic to any part of the study treatment.
  • Has had cancer treatment or investigational drugs within 4 weeks before starting the study.
  • Has had radiation therapy within 4 weeks before starting the study and has not fully recovered.
  • Is on ongoing steroid treatment.
  • Has had a live vaccine within 30 days before starting the study.
  • Is in another clinical trial or has used an investigational device within 4 weeks before starting the study.
  • Has active lymphoma in the central nervous system (CNS) unless in remission.
  • Has an active infection needing treatment.
  • Has HIV or active Hepatitis C infection.
  • Has a psychiatric or substance abuse disorder that would interfere with the study.

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