Home › Diffuse Large B-Cell Lymphoma › NCT06890884
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)
RecruitingPhase 2
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)
Who can join
Ages 18 and older · All sexes
Full 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.
About the study
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.
What is being tested
- Zilovertamab vedotin (biological)
- Rituximab (biological)
- Cyclophosphamide (drug)
- Doxorubicin (drug)
- Rituximab Biosimilar (biological)
- Prednisone (drug)
Sponsor: Merck Sharp & Dohme LLC · Participants: 594 · Started: Apr 11, 2025
Contact the study team
Official record on ClinicalTrials.gov — NCT06890884
Locations in the U.S.
| Alabama | Infirmary Cancer Care ( Site 0157), Mobile |
| Arizona | Ironwood Cancer & Research Centers ( Site 0204), Chandler Palo Verde Cancer Specialists ( Site 0105), Glendale City of Hope - Phoenix ( Site 0202), Goodyear |
| Arkansas | Genesis Cancer and Blood Institute ( Site 0193), Hot Springs |
| California | Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0135), Burbank City of Hope Comprehensive Cancer Center ( Site 0191), Duarte Bass Medical Group ( Site 0123), Walnut Creek |
| Colorado | Rocky Mountain Cancer Centers (RMCC) ( Site 8001), Aurora Colorado West Healthcare System-Grand Valley Oncology ( Site 0165), Grand Junction |
| Delaware | Medical Oncology Hematology Consultants (MOHC) ( Site 8007), Newark |
| District of Columbia | Georgetown University Medical Center ( Site 0117), Washington D.C. |
| Florida | Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0130), Boca Raton Baptist MD Anderson Cancer Center ( Site 0176), Jacksonville Mount Sinai Braman Comprehensive Cancer Center ( Site 0140), Miami Beach Mid Florida Hematology and Oncology Center ( Site 0152), Orange City |
| Idaho | Beacon Cancer Care ( Site 0142), Post Falls |
| Illinois | University of Chicago Medical Center ( Site 0126), Chicago Illinois Cancer Care ( Site 7005), Peoria |
| Iowa | University of Iowa-Holden Comprehensive Cancer Center ( Site 0139), Iowa City Mission Blood & Cancer Care ( Site 0114), Waukee |
| Kentucky | Saint Elizabeth Medical Center Edgewood ( Site 0141), Edgewood Baptist Health Hardin ( Site 0154), Elizabethtown Baptist Health Lexington ( Site 0127), Lexington Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0185), Louisville |
| Louisiana | Our Lady of the Lake Physician Group-Medical Oncology ( Site 0180), Baton Rouge Ochsner LSU Health - Monroe Medical Center, Family Medicine Clinic ( Site 0209), Monroe Ochsner Clinic Foundation ( Site 0189), New Orleans Louisiana State University Health Sciences Shreveport ( Site 0195), Shreveport |
| Massachusetts | Beth Israel Deaconess Medical Center ( Site 0161), Boston Dana Farber Cancer Institute ( Site 0111), Boston |
| Minnesota | Minnesota Oncology Hematology (MNO) ( Site 8004), Burnsville |
| Montana | Bozeman Health Deaconess Hospital ( Site 0183), Bozeman |
| Nebraska | NHO Revive Research Institute, LLC ( Site 0121), Lincoln University Of Nebraska Medical Center ( Site 0110), Omaha |
| New Jersey | Atlantic Health Morristown Medical Center ( Site 0163), Morristown Valley Health Systems - Ridgewood Campus ( Site 0125), Paramus |
| New York | Roswell Park Cancer Institute ( Site 0192), Buffalo Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0208), Mineola Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0108), New York SUNY Upstate Cancer Center ( Site 0178), Syracuse Optum Medical Care, PC ( Site 0122), Westbury |
| North Carolina | University of North Carolina Medical Center ( Site 0136), Chapel Hill Novant Health Presbyterian Medical Center ( Site 0177), Charlotte Novant Health Forsyth Medical Center ( Site 0206), Winston-Salem |
| Ohio | University of Cincinnati Medical Center ( Site 0156), Cincinnati Cleveland Clinic Main ( Site 0101), Cleveland Fairview Hospital-Moll Cancer Center ( Site 0198), Cleveland University Hospitals of Cleveland ( Site 0155), Cleveland Cleveland Clinic - Hillcrest Hospital-Hillcrest Hospital Cancer Center ( Site 0199), Mayfield Heights |
| Oregon | Providence Oncology and Hematology Clinic Westside ( Site 0179), Portland Providence Portland Medical Center ( Site 0120), Portland |
| Pennsylvania | Abramson Cancer Center and Perelman Center for Advanced Medicine ( Site 0131), Philadelphia Temple University Hospital ( Site 0133), Philadelphia Alliance Cancer Specialists (ACS) ( Site 8010), Sellersville Cancer Care Associates Of York ( Site 0174), York |
| South Carolina | Medical University of South Carolina ( Site 0153), Charleston |
| Tennessee | Tennessee Cancer Specialists ( Site 7004), Knoxville SCRI Oncology Partners ( Site 7002), Nashville |
| Texas | Texas Oncology - West Texas ( Site 8008), Amarillo Texas Oncology - Central/South Texas ( Site 8006), Austin UT Southwestern Medical Center ( Site 0190), Dallas Texas Oncology - Northeast Texas ( Site 8002), Palestine Texas Oncology - San Antonio ( Site 8009), San Antonio |
| Utah | Intermountain Medical Center ( Site 0182), Murray Intermountain Healthcare - St. George ( Site 0203), St. George |
| Virginia | Virginia Cancer Specialists, PC ( Site 8003), Manassas VCU Health Adult Outpatient Pavillion ( Site 0138), Richmond |
| Washington | Northwest Cancer Specialists (Compass Oncology) ( Site 8000), Vancouver |
| Wisconsin | SSM Health Dean Medical Group ( Site 0106), Madison Medical College of Wisconsin ( Site 0103), Milwaukee |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.