RECRUITING

A Clinical Study of Zilovertamab Vedotin (MK-2140) Plus Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Polatuzumab Vedotin Plus R-CHP in People With Diffuse Large B-cell Lymphoma (DLBCL) (MK-2140-011/waveLINE-011)

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Conditions

Lymphoma, Large B-Cell, Diffuse

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. GCB is a type of DLBCL that affects young B-cells that are still maturing. The goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP.

Official Title

A Randomized, Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Zilovertamab Vedotin (MK-2140) Plus R-CHP Versus Polatuzumab Vedotin Plus R-CHP in Treatment-naïve Participants With GCB Subtype of Diffuse Large B-cell Lymphoma (DLBCL)

Quick Facts

Study Start:2025-04-11
Study Completion:2032-12-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06890884

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Has histologically confirmed diagnosis of germinal center B-cell (GCB) subtype of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, according to the World Health Organization (WHO) classification of neoplasms of the hematopoietic and lymphoid tissues.
  2. * Has positron emission tomography (PET) positive disease at screening, defined as 4 to 5 on the Lugano 5-point scale.
  3. * Has received no prior treatment for their DLBCL.
  4. * Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART).
  5. * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load prior to randomization.
  6. * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.
  1. * Has a history of transformation of indolent disease to DLBCL.
  2. * Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma.
  3. * Has Ann Arbor Stage I DLBCL.
  4. * Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\<6 months prior to enrollment), myocardial infarction (\<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication.
  5. * Has clinically significant pericardial or pleural effusion.
  6. * Has ongoing Grade \>1 peripheral neuropathy.
  7. * Has a demyelinating form of Charcot-Marie-Tooth disease.
  8. * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
  9. * Has ongoing corticosteroid therapy.
  10. * Known additional malignancy that is progressing or has required active treatment within the past 2 years.
  11. * Known active central nervous system (CNS) lymphoma.
  12. * Has active autoimmune disease that has required systemic treatment in the past 2 years.
  13. * Has active infection requiring systemic therapy.
  14. * Has active HBV (defined as HBsAg positive and detectable HBV deoxyribonucleic acid (DNA)) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection.
  15. * Has history of stem cell/solid organ transplant.

Contacts and Locations

Study Contact

Toll Free Number
CONTACT
1-888-577-8839
Trialsites@msd.com

Principal Investigator

Medical Director
STUDY_DIRECTOR
Merck Sharp & Dohme LLC

Study Locations (Sites)

Mid Florida Hematology and Oncology Center ( Site 0152)
Orange City, Florida, 32763
United States

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

  • Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-11
Study Completion Date2032-12-16

Study Record Updates

Study Start Date2025-04-11
Study Completion Date2032-12-16

Terms related to this study

Additional Relevant MeSH Terms

  • Lymphoma, Large B-Cell, Diffuse