Actively Recruiting
Randomized Study of Zilovertamab Vedotin Plus R-CHP Versus Polatuzumab Vedotin Plus R-CHP in Treatment-Naïve GCB DLBCL
Led by Merck Sharp & Dohme LLC · Updated on 2026-06-08
594
Participants Needed
126
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL), a fast-growing blood cancer affecting immature B-cells. This phase 2 study compares the effects of zilovertamab vedotin combined with R-CHP chemotherapy versus polatuzumab vedotin combined with R-CHP in people newly diagnosed with this type of lymphoma. The goal is to see if the cancer responds better to one treatment over the other. Participants will be randomly assigned to receive either zilovertamab vedotin or polatuzumab vedotin, both given by intravenous infusion on the first day of each 3-week cycle for up to six cycles (about 4 months). Alongside these drugs, participants will receive cyclophosphamide, doxorubicin, and rituximab or a rituximab biosimilar by IV infusion, plus prednisone or prednisolone orally for five days each cycle. Those with high-risk DLBCL may receive two additional cycles of rituximab or its biosimilar. During the study, participants will have scans and tests to measure cancer response using established criteria over up to 31 months. Researchers will also monitor survival rates, quality of life, and side effects for up to several years. Safety assessments and treatment adherence will be tracked throughout the study and follow-up periods, ensuring thorough evaluation of each treatment's impact.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed germinal center B-cell subtype of diffuse large B-cell lymphoma (DLBCL) by prior biopsy
- PET positive disease at screening defined as 4 to 5 on the Lugano 5-point scale
- No prior treatment for diffuse large B-cell lymphoma
- Well controlled HIV infection on antiretroviral therapy (ART), if applicable
- Hepatitis B surface antigen positive participants must have received antiviral therapy and have undetectable viral load
- History of hepatitis C infection allowed if viral load is undetectable at screening
You will not qualify if you...
- History of transformation of indolent disease to diffuse large B-cell lymphoma
- Diagnosis of primary mediastinal B-cell lymphoma or Grey zone lymphoma
- Ann Arbor Stage I diffuse large B-cell lymphoma
- Active cardiovascular disease such as recent stroke (less than 6 months), myocardial infarction (less than 6 months), unstable angina, congestive heart failure (Class II or higher), or serious cardiac arrhythmia requiring medication
- Clinically significant pericardial or pleural effusion
- Ongoing Grade greater than 1 peripheral neuropathy
- Demyelinating form of Charcot-Marie-Tooth disease
- HIV-infected participants with history of Kaposi's sarcoma or Multicentric Castleman's Disease
- Ongoing corticosteroid therapy
- Additional malignancy progressing or requiring treatment within past 2 years
- Active central nervous system lymphoma
- Active autoimmune disease requiring systemic treatment in past 2 years
- Active infection requiring systemic therapy
- Active hepatitis B or C infection
- History of stem cell or solid organ transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 4 months
Participants receive intravenous infusions of study drugs plus oral prednisone or prednisolone during each 3-week cycle. The treatment lasts up to 6 cycles (approximately 4 months), with some participants receiving 2 additional cycles of rituximab or biosimilar depending on risk.
6 cycles with 1 infusion visit per cycle plus additional visits for oral medication during Days 1-5 of each cycle
Trial Site Locations
Total: 126 locations
1
Infirmary Cancer Care ( Site 0157)
Mobile, Alabama, United States, 36607
Actively Recruiting
2
Ironwood Cancer & Research Centers ( Site 0204)
Chandler, Arizona, United States, 85224
Actively Recruiting
3
Palo Verde Cancer Specialists ( Site 0105)
Glendale, Arizona, United States, 85304
Actively Recruiting
4
City of Hope - Phoenix ( Site 0202)
Goodyear, Arizona, United States, 85338
Actively Recruiting
5
Genesis Cancer and Blood Institute ( Site 0193)
Hot Springs, Arkansas, United States, 71913
Actively Recruiting
6
Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0135)
Burbank, California, United States, 91505
Actively Recruiting
7
City of Hope Comprehensive Cancer Center ( Site 0191)
Duarte, California, United States, 91010
Actively Recruiting
8
Bass Medical Group ( Site 0123)
Walnut Creek, California, United States, 94598
Actively Recruiting
9
Rocky Mountain Cancer Centers (RMCC) ( Site 8001)
Aurora, Colorado, United States, 80012
Actively Recruiting
10
Colorado West Healthcare System-Grand Valley Oncology ( Site 0165)
Grand Junction, Colorado, United States, 81505
Actively Recruiting
11
Medical Oncology Hematology Consultants (MOHC) ( Site 8007)
Newark, Delaware, United States, 19713
Actively Recruiting
12
Georgetown University Medical Center ( Site 0117)
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
13
Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0130)
Boca Raton, Florida, United States, 33486
Actively Recruiting
14
Baptist MD Anderson Cancer Center ( Site 0176)
Jacksonville, Florida, United States, 32207
Actively Recruiting
15
Mount Sinai Braman Comprehensive Cancer Center ( Site 0140)
Miami Beach, Florida, United States, 33140
Actively Recruiting
16
Mid Florida Hematology and Oncology Center ( Site 0152)
Orange City, Florida, United States, 32763
Actively Recruiting
17
Beacon Cancer Care ( Site 0142)
Post Falls, Idaho, United States, 83854
Actively Recruiting
18
University of Chicago Medical Center ( Site 0126)
Chicago, Illinois, United States, 60637
Actively Recruiting
19
Illinois Cancer Care ( Site 7005)
Peoria, Illinois, United States, 61615
Actively Recruiting
20
University of Iowa-Holden Comprehensive Cancer Center ( Site 0139)
Iowa City, Iowa, United States, 52242
Actively Recruiting
21
Mission Blood & Cancer Care ( Site 0114)
Waukee, Iowa, United States, 50263
Actively Recruiting
22
Saint Elizabeth Medical Center Edgewood ( Site 0141)
Edgewood, Kentucky, United States, 41017
Actively Recruiting
23
Baptist Health Hardin ( Site 0154)
Elizabethtown, Kentucky, United States, 42701
Actively Recruiting
24
Baptist Health Lexington ( Site 0127)
Lexington, Kentucky, United States, 40503
Actively Recruiting
25
Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0185)
Louisville, Kentucky, United States, 40207
Actively Recruiting
26
Our Lady of the Lake Physician Group-Medical Oncology ( Site 0180)
Baton Rouge, Louisiana, United States, 70808
Actively Recruiting
27
Ochsner LSU Health - Monroe Medical Center, Family Medicine Clinic ( Site 0209)
Monroe, Louisiana, United States, 71202
Actively Recruiting
28
Ochsner Clinic Foundation ( Site 0189)
New Orleans, Louisiana, United States, 70121
Actively Recruiting
29
Louisiana State University Health Sciences Shreveport ( Site 0195)
Shreveport, Louisiana, United States, 71103
Actively Recruiting
30
Dana Farber Cancer Institute ( Site 0111)
Boston, Massachusetts, United States, 02215
Actively Recruiting
31
Minnesota Oncology Hematology (MNO) ( Site 8004)
Burnsville, Minnesota, United States, 55337
Actively Recruiting
32
Bozeman Health Deaconess Hospital ( Site 0183)
Bozeman, Montana, United States, 59715
Actively Recruiting
33
NHO Revive Research Institute, LLC ( Site 0121)
Lincoln, Nebraska, United States, 68506
Actively Recruiting
34
University Of Nebraska Medical Center ( Site 0110)
Omaha, Nebraska, United States, 68198
Actively Recruiting
35
Atlantic Health Morristown Medical Center ( Site 0163)
Morristown, New Jersey, United States, 07960
Actively Recruiting
36
Valley Health Systems - Ridgewood Campus ( Site 0125)
Paramus, New Jersey, United States, 07652
Actively Recruiting
37
Erie County Medical Center ( Site 0175)
Buffalo, New York, United States, 14215
Actively Recruiting
38
Roswell Park Cancer Institute ( Site 0192)
Buffalo, New York, United States, 14263
Actively Recruiting
39
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0208)
Mineola, New York, United States, 11501
Actively Recruiting
40
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0108)
New York, New York, United States, 10016
Actively Recruiting
41
SUNY Upstate Cancer Center ( Site 0178)
Syracuse, New York, United States, 13210
Actively Recruiting
42
Clinical Research Alliance ( Site 0122)
Westbury, New York, United States, 11590
Actively Recruiting
43
University of North Carolina Medical Center ( Site 0136)
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
44
Novant Health Presbyterian Medical Center ( Site 0177)
Charlotte, North Carolina, United States, 28204
Actively Recruiting
45
Novant Health Forsyth Medical Center ( Site 0206)
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
46
University of Cincinnati Medical Center ( Site 0156)
Cincinnati, Ohio, United States, 45219
Actively Recruiting
47
University Hospitals of Cleveland ( Site 0155)
Cleveland, Ohio, United States, 44106
Actively Recruiting
48
Fairview Hospital-Moll Cancer Center ( Site 0198)
Cleveland, Ohio, United States, 44111
Actively Recruiting
49
Cleveland Clinic Main ( Site 0101)
Cleveland, Ohio, United States, 44195
Actively Recruiting
50
Cleveland Clinic - Hillcrest Hospital-Hillcrest Hospital Cancer Center ( Site 0199)
Mayfield Heights, Ohio, United States, 44124
Actively Recruiting
51
Providence Portland Medical Center ( Site 0120)
Portland, Oregon, United States, 97213
Actively Recruiting
52
Providence Oncology and Hematology Clinic Westside ( Site 0179)
Portland, Oregon, United States, 97225
Actively Recruiting
53
Temple University Hospital ( Site 0133)
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
54
Alliance Cancer Specialists (ACS) ( Site 8010)
Sellersville, Pennsylvania, United States, 18960
Actively Recruiting
55
Cancer Care Associates Of York ( Site 0174)
York, Pennsylvania, United States, 17403
Actively Recruiting
56
Medical University of South Carolina ( Site 0153)
Charleston, South Carolina, United States, 29425
Actively Recruiting
57
Tennessee Cancer Specialists ( Site 7004)
Knoxville, Tennessee, United States, 37909
Actively Recruiting
58
SCRI Oncology Partners ( Site 7002)
Nashville, Tennessee, United States, 37203
Actively Recruiting
59
Texas Oncology - West Texas ( Site 8008)
Amarillo, Texas, United States, 79124
Actively Recruiting
60
Texas Oncology - Central/South Texas ( Site 8006)
Austin, Texas, United States, 78705
Actively Recruiting
61
Texas Oncology - Northeast Texas ( Site 8002)
Palestine, Texas, United States, 75801
Actively Recruiting
62
Texas Oncology - San Antonio ( Site 8009)
San Antonio, Texas, United States, 78240
Actively Recruiting
63
The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0145)
Tyler, Texas, United States, 75701
Completed
64
Intermountain Medical Center ( Site 0182)
Murray, Utah, United States, 84107
Actively Recruiting
65
Intermountain Healthcare - St. George ( Site 0203)
St. George, Utah, United States, 84790
Actively Recruiting
66
Virginia Cancer Specialists, PC ( Site 8003)
Manassas, Virginia, United States, 20110
Actively Recruiting
67
VCU Health Adult Outpatient Pavillion ( Site 0138)
Richmond, Virginia, United States, 23219
Actively Recruiting
68
Northwest Cancer Specialists (Compass Oncology) ( Site 8000)
Vancouver, Washington, United States, 98684
Actively Recruiting
69
SSM Health Dean Medical Group ( Site 0106)
Madison, Wisconsin, United States, 53715
Actively Recruiting
70
Medical College of Wisconsin ( Site 0103)
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
71
AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0306)
Mechelen, Antwerpen, Belgium, 2800
Actively Recruiting
72
CHU HELORA asbl ( Site 0304)
Mons, Brabant Wallon, Belgium, 7000
Actively Recruiting
73
Cliniques Universitaires Saint-Luc ( Site 0302)
Brussels, Bruxelles-Capitale, Region de, Belgium, 1200
Actively Recruiting
74
UZ Leuven ( Site 0301)
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
75
AZ Delta ( Site 0303)
Roeselare, West-Vlaanderen, Belgium, 8800
Actively Recruiting
76
Klinikum Stuttgart. Klinik fur Hamatologie. Onkologie. Palliativmedizin und Stammzelltransplantation ( Site 0419)
Stuttgart, Baden-Wurttemberg, Germany, 70174
Actively Recruiting
77
Uniklinik Erlangen ( Site 0412)
Erlangen, Bavaria, Germany, 91054
Actively Recruiting
78
Universitaetsklinikum Wuerzburg ( Site 0401)
Würzburg, Bavaria, Germany, 97080
Actively Recruiting
79
Dietrich Bonhoeffer Klinikum-Neubrandenburg ( Site 0439)
Neubrandenburg, Mecklenburg-Vorpommern, Germany, 17036
Actively Recruiting
80
HELIOS Klinikum Wuppertal ( Site 0435)
Wuppertal, North Rhine-Westphalia, Germany, 42283
Actively Recruiting
81
Otto-Von-Guericke-Universitaet Magdeburg ( Site 0411)
Magdeburg, Saxony-Anhalt, Germany, 39120
Actively Recruiting
82
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck ( Site 0425)
Lübeck, Schleswig-Holstein, Germany, 23562
Actively Recruiting
83
St Vincent's University Hospital ( Site 0502)
Dublin, Dublin, Ireland, D04 T6F4
Actively Recruiting
84
Mater Misercordiae University Hospital ( Site 0501)
Dublin, Ireland, D07 R2WY
Actively Recruiting
85
University Hospital Limerick ( Site 0503)
Limerick, Ireland, V94 F858
Actively Recruiting
86
Soroka Medical Center ( Site 0606)
Beersheba, Israel, 8410101
Actively Recruiting
87
Rambam Health Care Campus ( Site 0604)
Haifa, Israel, 3109601
Actively Recruiting
88
Edith Wolfson Medical Center ( Site 0602)
Holon, Israel, 5810001
Actively Recruiting
89
Haddasah Medical Center ( Site 0601)
Jerusalem, Israel, 9112001
Actively Recruiting
90
Rabin Medical Center ( Site 0607)
Petah Tikva, Israel, 4941492
Actively Recruiting
91
Sheba Medical Center ( Site 0603)
Ramat Gan, Israel, 5265601
Actively Recruiting
92
ZIV Medical Center ( Site 0605)
Safed, Israel, 13100
Actively Recruiting
93
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 0707)
Meldola, Forli-Cesena, Italy, 47014
Actively Recruiting
94
Istituto Clinico Humanitas ( Site 0704)
Rozzano, Milano, Italy, 20089
Actively Recruiting
95
Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 0703)
Alessandria, Italy, 15121
Actively Recruiting
96
Istituto Europeo di Oncologia ( Site 0701)
Milan, Italy, 20141
Actively Recruiting
97
Universita degli Studi di Napoli Federico II ( Site 0705)
Naples, Italy, 80131
Actively Recruiting
98
Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO ( Site 0702)
Palermo, Italy, 90146
Actively Recruiting
99
Arcispedale Santa Maria Nuova ( Site 0706)
Reggio Emilia, Italy, 42123
Actively Recruiting
100
Aichi Cancer Center ( Site 1007)
Nagoya, Aichi-ken, Japan, 464-8681
Actively Recruiting
101
Fujita Health University Hospital ( Site 1003)
Toyoake, Aichi-ken, Japan, 470-1192
Actively Recruiting
102
Hokkaido University Hospital ( Site 1004)
Sapporo, Hokkaido, Japan, 060-8648
Actively Recruiting
103
National Hospital Organization Sendai Medical Center ( Site 1005)
Sendai, Miyagi, Japan, 983-8520
Actively Recruiting
104
Kansai Medical University Hospital ( Site 1006)
Hirakata, Osaka, Japan, 573-1191
Actively Recruiting
105
Shimane University Hospital ( Site 1002)
Izumo, Shimane, Japan, 693-8501
Actively Recruiting
106
Nippon Medical School Hospital ( Site 1001)
Bunkyo, Tokyo, Japan, 113-8603
Actively Recruiting
107
National Cancer Center Hospital ( Site 1009)
Chūō, Tokyo, Japan, 104-0045
Actively Recruiting
108
Nagasaki University Hospital ( Site 1008)
Nagasaki, Japan, 852-8501
Actively Recruiting
109
Pratia MCM Krakow ( Site 0804)
Karkow, Lesser Poland Voivodeship, Poland, 30-727
Actively Recruiting
110
Szpital Specjalistyczny im. Jedrzeja Sniadeckiego w Nowym Saczu ( Site 0806)
Nowy Sącz, Lesser Poland Voivodeship, Poland, 33-300
Actively Recruiting
111
Specjalistyczny Szpital im. Dr Alfreda Sokolowskiego w Walbrzychu ( Site 0807)
Wałbrzych, Lower Silesian Voivodeship, Poland, 58-309
Actively Recruiting
112
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0803)
Warsaw, Masovian Voivodeship, Poland, 02-781
Actively Recruiting
113
Uniwersyteckie Centrum Kliniczne ( Site 0802)
Gdansk, Pomeranian Voivodeship, Poland, 80-214
Actively Recruiting
114
Pratia Onkologia Katowice ( Site 0801)
Katowice, Silesian Voivodeship, Poland, 40-519
Actively Recruiting
115
Bristol Haematology and Oncology Centre ( Site 0908)
Bristol, Bristol, City of, United Kingdom, BS2 8ED
Actively Recruiting
116
Stoke Mandeville Hospital ( Site 0917)
Aylesbury, Buckinghamshire, United Kingdom, HP21 8AL
Actively Recruiting
117
Royal Devon & Exeter Hospital ( Site 0910)
Exeter, Devon, United Kingdom, EX2 5DW
Actively Recruiting
118
University Hospitals Plymouth NHS Trust ( Site 0905)
Plymouth, Devon, United Kingdom, PL68DH
Actively Recruiting
119
The James Cook University Hospital ( Site 0909)
Middlesbrough, England, United Kingdom, TS4 3BW
Actively Recruiting
120
Lincoln County Hospital ( Site 0906)
Lincoln, Lincolnshire, United Kingdom, LN2 5QY
Actively Recruiting
121
Guy s & St Thomas NHS Foundation Trust ( Site 0904)
London, London, City of, United Kingdom, SE1 9RT
Actively Recruiting
122
Hammersmith Hospital ( Site 0915)
London, London, City of, United Kingdom, W12 0 HS
Actively Recruiting
123
Churchill Hospital ( Site 0903)
Oxford, Oxfordshire, United Kingdom, OX3 7LJ
Actively Recruiting
124
Queen Elizabeth Hospital Birmingham ( Site 0912)
Birmingham, United Kingdom, B15 2TH
Actively Recruiting
125
Clatterbridge Cancer Centre - Liverpool ( Site 0911)
Liverpool, United Kingdom, L7 8YA
Actively Recruiting
126
Christie Hospital NHS Trust ( Site 0901)
Manchester, United Kingdom, M20 4BX
Actively Recruiting
Research Team
T
Toll Free Number
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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