Study Comparing Zilovertamab Vedotin with Standard Treatment for Untreated Diffuse Large B-Cell Lymphoma (DLBCL)

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40

ClinicalTrials ID:NCT06717347

This clinical trial is testing whether adding the drug zilovertamab vedotin to the standard treatment can help people with untreated Diffuse Large B-Cell Lymphoma (DLBCL) live longer without their cancer growing or spreading, compared to those receiving only the standard treatment.

Patient Parameters

Program Overview

The aim of this study is to find out if combining a new drug, zilovertamab vedotin, with the usual treatment can improve outcomes for people with Diffuse Large B-Cell Lymphoma (DLBCL) who have not been treated before. Researchers want to see if this combination helps patients live longer without their cancer getting worse, compared to those who receive the standard treatment alone.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL) through a biopsy.
  • Cancer shows up on a PET scan as active.
  • Have not received any previous treatment for DLBCL.
  • In good general health, with an ECOG performance status of 0 to 2.
  • Heart function is adequate, with an ejection fraction of 45% or higher.
  • If HIV positive, the virus must be well controlled with medication.
  • If hepatitis B positive, must be on antiviral therapy with undetectable viral load.
  • If previously infected with hepatitis C, the virus must be undetectable.

Exclusion Criteria

  • History of a slow-growing disease turning into DLBCL.
  • Diagnosed with primary mediastinal B-cell lymphoma or Grey zone lymphoma.
  • Have Stage I DLBCL.
  • Have serious heart problems, such as recent stroke or heart attack, unstable chest pain, or heart failure.
  • Have significant fluid around the heart or lungs.
  • Have severe nerve damage.
  • Have a specific nerve disease called Charcot-Marie-Tooth disease.
  • If HIV positive, have a history of certain cancers like Kaposi's sarcoma.
  • Currently taking corticosteroids.
  • Have received a live vaccine within 30 days before starting the study treatment.
  • Have another cancer that is active or has needed treatment in the last 2 years.
  • Have active cancer in the brain or spinal cord.
  • Have an autoimmune disease needing treatment in the last 2 years.
  • Have an active infection needing treatment.
  • Have active hepatitis B and C infections.
  • Have had a tissue or organ transplant.

Locations

FACILITYZIPCITYSTATE
Cotton O'Neil Cancer Center ( Site 0108)66606TopekaKansas
OptumCare Cancer Care ( Site 0121)89102Las VegasNevada
Comprehensive Cancer Centers of Nevada ( Site 0113)89169Las VegasNevada
New York Oncology Hematology, P.C. ( Site 0129)12206AlbanyNew York
Blue Ridge Cancer Care ( Site 0132)24014RoanokeVirginia

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