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)
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT06890884
This study evaluates the efficacy of zilovertamab vedotin plus R-CHP versus polatuzumab vedotin plus R-CHP in treating GCB DLBCL. Eligible participants must have confirmed GCB DLBCL, PET-positive disease, and no prior DLBCL treatment. Interventions include IV infusions of biologicals and drugs, with rescue medication as needed.
Patient Parameters
| Parameter | Options |
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Program Overview
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.
Eligibility 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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Infirmary Cancer Care ( Site 0157) | 36607 | Mobile | Alabama |
| Palo Verde Cancer Specialists ( Site 0105) | 85304 | Glendale | Arizona |
| Genesis Cancer and Blood Institute ( Site 0193) | 71913 | Hot Springs | Arkansas |
| Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0135) | 91505 | Burbank | California |
| Medical Oncology Hematology Consultants (MOHC) ( Site 8007) | 19713 | Newark | Delaware |
| Georgetown University Medical Center ( Site 0117) | 20007 | Washington D.C. | District of Columbia |
| Mount Sinai Cancer Center ( Site 0140) | 33140 | Miami Beach | Florida |
| Mid Florida Hematology and Oncology Center ( Site 0152) | 32763 | Orange City | Florida |
| University of Chicago Medical Center ( Site 0126) | 60637 | Chicago | Illinois |
| University of Iowa-Holden Comprehensive Cancer Center ( Site 0139) | 52242 | Iowa City | Iowa |
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