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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)
Trial Status: active
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.
Inclusion Criteria
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- 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.
- Has positron emission tomography (PET) positive disease at screening, defined as 4
to 5 on the Lugano 5-point scale.
- Has received no prior treatment for their DLBCL.
- Human immunodeficiency virus (HIV) infected participants must have well controlled
HIV on antiretroviral therapy (ART).
- 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.
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV
viral load is undetectable at screening.
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Has a history of transformation of indolent disease to DLBCL.
- Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone
lymphoma.
- Has Ann Arbor Stage I DLBCL.
- 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.
- Has clinically significant pericardial or pleural effusion.
- Has ongoing Grade >1 peripheral neuropathy.
- Has a demyelinating form of Charcot-Marie-Tooth disease.
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric
Castleman's Disease.
- Has ongoing corticosteroid therapy.
- Known additional malignancy that is progressing or has required active treatment
within the past 2 years.
- Known active central nervous system (CNS) lymphoma.
- Has active autoimmune disease that has required systemic treatment in the past 2
years.
- Has active infection requiring systemic therapy.
- 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.
- Has history of stem cell/solid organ transplant.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06890884.
Locations matching your search criteria
United States
District of Columbia
Washington
MedStar Georgetown University Hospital
Status: Active
Name Not Available
Illinois
Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not Available
Iowa
Iowa City
University of Iowa/Holden Comprehensive Cancer Center
Status: Active
Name Not Available
Nebraska
Omaha
University of Nebraska Medical Center
Status: Active
Name Not Available
New York
Buffalo
Roswell Park Cancer Institute
Status: Active
Name Not Available
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone