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

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.

Locations

FACILITYZIPCITYSTATE
Bass Medical Group ( Site 0166)94598Walnut CreekCalifornia
Innovative Clinical Research Institute ( Site 0122)90603WhittierCalifornia
Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0133)40207LouisvilleKentucky
Louisiana State University Health Sciences Center New Orleans ( Site 0134)70112New OrleansLouisiana
University of Maryland ( Site 0123)21201BaltimoreMaryland
Dana-Farber Cancer Institute-Lymphoma ( Site 0111)02215BostonMassachusetts
University of Massachusetts Medical School ( Site 0119)01655WorcesterMassachusetts
St. Vincent Frontier Cancer Center-Research ( Site 0108)59102BillingsMontana
Atlantic Health System ( Site 0116)07960MorristownNew Jersey
New York Medical College ( Site 0113)10595ValhallaNew York

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