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)

Recruiting now · Phase 2

Conditions studied: Lymphoma, Large B-Cell, Diffuse

In brief

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.

Key facts

Study ID

NCT06890884

Run by

Merck Sharp & Dohme LLC

People needed

594

Starts

2025-04-11

Expected to finish

2032-12-16

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Ironwood Cancer & Research Centers ( Site 0204) — Chandler, Arizona, United States (enrolling)
• Palo Verde Cancer Specialists ( Site 0105) — Glendale, Arizona, United States (enrolling)
• City of Hope - Phoenix ( Site 0202) — Goodyear, Arizona, United States (enrolling)
• Genesis Cancer and Blood Institute ( Site 0193) — Hot Springs, Arkansas, United States (enrolling)
• Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0135) — Burbank, California, United States (enrolling)
• City of Hope Comprehensive Cancer Center ( Site 0191) — Duarte, California, United States (enrolling)
• Bass Medical Group ( Site 0123) — Walnut Creek, California, United States (enrolling)
• Rocky Mountain Cancer Centers (RMCC) ( Site 8001) — Aurora, Colorado, United States (enrolling)
• Colorado West Healthcare System-Grand Valley Oncology ( Site 0165) — Grand Junction, Colorado, United States (enrolling)
• Medical Oncology Hematology Consultants (MOHC) ( Site 8007) — Newark, Delaware, United States (enrolling)
• Georgetown University Medical Center ( Site 0117) — Washington D.C., District of Columbia, United States (enrolling)
• Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0130) — Boca Raton, Florida, United States (enrolling)
• Baptist MD Anderson Cancer Center ( Site 0176) — Jacksonville, Florida, United States (enrolling)
• Mount Sinai Braman Comprehensive Cancer Center ( Site 0140) — Miami Beach, Florida, United States (enrolling)
• Mid Florida Hematology and Oncology Center ( Site 0152) — Orange City, Florida, United States (enrolling)
• Beacon Cancer Care ( Site 0142) — Post Falls, Idaho, United States (enrolling)
• University of Chicago Medical Center ( Site 0126) — Chicago, Illinois, United States (enrolling)
• Illinois Cancer Care ( Site 7005) — Peoria, Illinois, United States (enrolling)
• University of Iowa-Holden Comprehensive Cancer Center ( Site 0139) — Iowa City, Iowa, United States (enrolling)
• Mission Blood & Cancer Care ( Site 0114) — Waukee, Iowa, United States (enrolling)
• Saint Elizabeth Medical Center Edgewood ( Site 0141) — Edgewood, Kentucky, United States (enrolling)
• Baptist Health Hardin ( Site 0154) — Elizabethtown, Kentucky, United States (enrolling)
• Baptist Health Lexington ( Site 0127) — Lexington, Kentucky, United States (enrolling)
• Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0185) — Louisville, Kentucky, United States (enrolling)
• Infirmary Cancer Care ( Site 0157) — Mobile, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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