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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06717347




Registration number
NCT06717347
Ethics application status
Date submitted
2/12/2024
Date registered
5/12/2024
Date last updated
26/09/2025

Titles & IDs
Public title
A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010)
Scientific title
A Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) (waveLINE-010)
Secondary ID [1] 0 0
MK-2140-010
Secondary ID [2] 0 0
2140-010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diffuse Large B-Cell Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Zilovertamab vedotin
Treatment: Other - Rituximab
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Doxorubicin
Treatment: Other - Rituximab Biosimilar
Treatment: Drugs - Prednisone
Treatment: Drugs - Prednisolone
Treatment: Drugs - Vincristine
Treatment: Drugs - Rescue medication

Experimental: Zilovertamab vedotin + Rituximab + Cyclophosphamide, Doxorubicin, Prednisone (R-CHP) - Participants receive a dose of zilovertamab vedotin (1.75 mg/kg) plus 750 mg/m\^2 cyclophosphamide, 50 mg/m\^2 doxorubicin, and 375 mg/m\^2 rituximab or rituximab biosimilar administered by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 6 cycles (up to approximately 4 months) plus 2 cycles of rituximab or biosimilar for participants with high risk DLBCL. Participants also receive 100 mg prednisone or prednisolone via oral tablet per day during Days 1-5 of each 21-day cycle for up to 6 cycles (up to approximately 4 months).

Active comparator: Rituximab + Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (R-CHOP) - Participants receive 750 mg/m\^2 cyclophosphamide, 50 mg/m\^2 doxorubicin, and 375 mg/m\^2 rituximab or rituximab biosimilar, 1.4 mg/m\^2 vincristine administered by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 6 cycles (up to approximately 4 months) plus 2 cycles of rituximab or biosimilar for participants with high risk DLBCL. Participants also receive 100 mg prednisone or prednisolone via oral tablet per day during Days 1-5 of each 21-day cycle for up to 6 cycles (up to approximately 4 months).


Treatment: Other: Zilovertamab vedotin
IV infusion

Treatment: Other: Rituximab
IV infusion

Treatment: Drugs: Cyclophosphamide
IV infusion

Treatment: Drugs: Doxorubicin
IV infusion

Treatment: Other: Rituximab Biosimilar
IV infusion

Treatment: Drugs: Prednisone
Per Approved Product Label

Treatment: Drugs: Prednisolone
Oral administration

Treatment: Drugs: Vincristine
IV infusion

Treatment: Drugs: Rescue medication
Participants receive rescue medication at the investigator's discretion, per approved product label. The recommended rescue medication is granulocyte colony-stimulating factor (G-CSF).
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (PFS)
Timepoint [1] 0 0
Up to ~ 50 months
Secondary outcome [1] 0 0
Complete Response at End of Treatment (CR at EOT)
Timepoint [1] 0 0
Up to ~ 32 months
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Up to ~ 74 months
Secondary outcome [3] 0 0
Event-free Survival (EFS)
Timepoint [3] 0 0
Up to ~ 74 months
Secondary outcome [4] 0 0
Duration of Complete Response (DurCR)
Timepoint [4] 0 0
Up to ~ 74 months
Secondary outcome [5] 0 0
Number of Participants Who Experience an Adverse Event (AE)
Timepoint [5] 0 0
Up to ~ 9 months
Secondary outcome [6] 0 0
Number of Participants Who Discontinue Study Treatment Due to an AE
Timepoint [6] 0 0
Up to ~ 6 months
Secondary outcome [7] 0 0
Change From Baseline in Health-Related Quality Of Life (HRQoL) on Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Trial Outcome Index (TOI) Score
Timepoint [7] 0 0
Baseline and Week 25
Secondary outcome [8] 0 0
Change From Baseline in HRQoL on FACT-Lym Total Score
Timepoint [8] 0 0
Baseline and Week 25
Secondary outcome [9] 0 0
Change From Baseline in HRQoL on FACT-Lym Physical Wellbeing (PWB) Score
Timepoint [9] 0 0
Baseline and Week 25
Secondary outcome [10] 0 0
Change From Baseline in HRQoL on Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) Neurotoxicity Subscale Score
Timepoint [10] 0 0
Baseline and Week 25

Eligibility
Key inclusion criteria
* Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, based on local testing according to the 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
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization
* Has an ejection fraction =45% as determined by either echocardiogram (ECHO) or multigated acquisition (MUGA)
* Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
* 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 concurrent active HBV (defined as HBsAg positive and detectable HBV DNA) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection
* Has history of allogeneic tissue/solid organ transplant

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/01/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/03/2032
Actual
Sample size
Target
1046
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
Townsville University Hospital ( Site 3006) - Douglas
Recruitment hospital [2] 0 0
Grampians Health ( Site 3003) - Ballarat
Recruitment hospital [3] 0 0
Royal Perth Hospital-Haematology ( Site 3004) - Perth
Recruitment postcode(s) [1] 0 0
4814 - Douglas
Recruitment postcode(s) [2] 0 0
3350 - Ballarat
Recruitment postcode(s) [3] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
Nevada
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
United States of America
State/province [15] 0 0
Wisconsin
Country [16] 0 0
Argentina
State/province [16] 0 0
Buenos Aires
Country [17] 0 0
Argentina
State/province [17] 0 0
Buenos Aires F.D.
Country [18] 0 0
Argentina
State/province [18] 0 0
Santa Fe Province
Country [19] 0 0
Argentina
State/province [19] 0 0
Tucumán Province
Country [20] 0 0
Argentina
State/province [20] 0 0
CABA
Country [21] 0 0
Argentina
State/province [21] 0 0
San Juan
Country [22] 0 0
Belgium
State/province [22] 0 0
Antwerpen
Country [23] 0 0
Belgium
State/province [23] 0 0
Hainaut
Country [24] 0 0
Brazil
State/province [24] 0 0
Paraná
Country [25] 0 0
Brazil
State/province [25] 0 0
Rio Grande do Norte
Country [26] 0 0
Brazil
State/province [26] 0 0
Santa Catarina
Country [27] 0 0
Brazil
State/province [27] 0 0
São Paulo
Country [28] 0 0
Canada
State/province [28] 0 0
Ontario
Country [29] 0 0
Chile
State/province [29] 0 0
Coquimbo Region
Country [30] 0 0
Chile
State/province [30] 0 0
Los Ríos Region
Country [31] 0 0
Chile
State/province [31] 0 0
Region M. de Santiago
Country [32] 0 0
Chile
State/province [32] 0 0
Región de Valparaíso
Country [33] 0 0
Chile
State/province [33] 0 0
Región del Biobío
Country [34] 0 0
China
State/province [34] 0 0
Anhui
Country [35] 0 0
China
State/province [35] 0 0
Beijing Municipality
Country [36] 0 0
China
State/province [36] 0 0
Chongqing Municipality
Country [37] 0 0
China
State/province [37] 0 0
Fujian
Country [38] 0 0
China
State/province [38] 0 0
Guangdong
Country [39] 0 0
China
State/province [39] 0 0
Guangxi
Country [40] 0 0
China
State/province [40] 0 0
Guizhou
Country [41] 0 0
China
State/province [41] 0 0
Hubei
Country [42] 0 0
China
State/province [42] 0 0
Jiangsu
Country [43] 0 0
China
State/province [43] 0 0
Jiangxi
Country [44] 0 0
China
State/province [44] 0 0
Jilin
Country [45] 0 0
China
State/province [45] 0 0
Shandong
Country [46] 0 0
China
State/province [46] 0 0
Shanghai Municipality
Country [47] 0 0
China
State/province [47] 0 0
Shanxi
Country [48] 0 0
China
State/province [48] 0 0
Sichuan
Country [49] 0 0
China
State/province [49] 0 0
Tianjin Municipality
Country [50] 0 0
China
State/province [50] 0 0
Yunnan
Country [51] 0 0
China
State/province [51] 0 0
Zhejiang
Country [52] 0 0
Colombia
State/province [52] 0 0
Antioquia
Country [53] 0 0
Colombia
State/province [53] 0 0
Bogota D.C.
Country [54] 0 0
Colombia
State/province [54] 0 0
Departamento de Córdoba
Country [55] 0 0
Colombia
State/province [55] 0 0
Risaralda Department
Country [56] 0 0
Colombia
State/province [56] 0 0
Valle del Cauca Department
Country [57] 0 0
Denmark
State/province [57] 0 0
Central Jutland
Country [58] 0 0
Denmark
State/province [58] 0 0
North Denmark
Country [59] 0 0
France
State/province [59] 0 0
Alpes-Maritimes
Country [60] 0 0
France
State/province [60] 0 0
Charente-Maritime
Country [61] 0 0
France
State/province [61] 0 0
Cote-d Or
Country [62] 0 0
France
State/province [62] 0 0
Hauts-de-Seine
Country [63] 0 0
France
State/province [63] 0 0
Isere
Country [64] 0 0
France
State/province [64] 0 0
Limousin
Country [65] 0 0
France
State/province [65] 0 0
Moselle
Country [66] 0 0
France
State/province [66] 0 0
Nord
Country [67] 0 0
France
State/province [67] 0 0
Puy-de-Dome
Country [68] 0 0
France
State/province [68] 0 0
Pyrenees-Atlantiques
Country [69] 0 0
France
State/province [69] 0 0
Var
Country [70] 0 0
France
State/province [70] 0 0
Vaucluse
Country [71] 0 0
France
State/province [71] 0 0
Vendee
Country [72] 0 0
Greece
State/province [72] 0 0
Attica
Country [73] 0 0
Greece
State/province [73] 0 0
Evros
Country [74] 0 0
Guatemala
State/province [74] 0 0
Guatemala City
Country [75] 0 0
Hong Kong
State/province [75] 0 0
Hong Kong
Country [76] 0 0
Hungary
State/province [76] 0 0
Szabolcs-Szatmár-Bereg
Country [77] 0 0
Israel
State/province [77] 0 0
Haifa
Country [78] 0 0
Israel
State/province [78] 0 0
Jerusalem
Country [79] 0 0
Israel
State/province [79] 0 0
Tel Aviv
Country [80] 0 0
Israel
State/province [80] 0 0
Tiberias
Country [81] 0 0
Italy
State/province [81] 0 0
Lombardy
Country [82] 0 0
Italy
State/province [82] 0 0
Potenza
Country [83] 0 0
Italy
State/province [83] 0 0
Torino
Country [84] 0 0
Italy
State/province [84] 0 0
Ancona
Country [85] 0 0
Italy
State/province [85] 0 0
Brescia
Country [86] 0 0
Italy
State/province [86] 0 0
Milan
Country [87] 0 0
Italy
State/province [87] 0 0
Novara
Country [88] 0 0
Italy
State/province [88] 0 0
Palermo
Country [89] 0 0
Italy
State/province [89] 0 0
Ravenna
Country [90] 0 0
Italy
State/province [90] 0 0
Roma
Country [91] 0 0
Japan
State/province [91] 0 0
Aichi-ken
Country [92] 0 0
Japan
State/province [92] 0 0
Ehime
Country [93] 0 0
Japan
State/province [93] 0 0
Hyogo
Country [94] 0 0
Japan
State/province [94] 0 0
Ishikawa-ken
Country [95] 0 0
Japan
State/province [95] 0 0
Kanagawa
Country [96] 0 0
Japan
State/province [96] 0 0
Miyagi
Country [97] 0 0
Japan
State/province [97] 0 0
Osaka
Country [98] 0 0
Japan
State/province [98] 0 0
Saitama
Country [99] 0 0
Japan
State/province [99] 0 0
Tokyo
Country [100] 0 0
Japan
State/province [100] 0 0
Yamanashi
Country [101] 0 0
Japan
State/province [101] 0 0
Chiba
Country [102] 0 0
Japan
State/province [102] 0 0
Fukuoka
Country [103] 0 0
Japan
State/province [103] 0 0
Hiroshima
Country [104] 0 0
Japan
State/province [104] 0 0
Kyoto
Country [105] 0 0
Japan
State/province [105] 0 0
Miyazaki
Country [106] 0 0
Japan
State/province [106] 0 0
Okayama
Country [107] 0 0
Japan
State/province [107] 0 0
Yamagata
Country [108] 0 0
Malaysia
State/province [108] 0 0
Sabah
Country [109] 0 0
Malaysia
State/province [109] 0 0
Sarawak
Country [110] 0 0
Malaysia
State/province [110] 0 0
Selangor
Country [111] 0 0
Mexico
State/province [111] 0 0
Coahuila
Country [112] 0 0
Mexico
State/province [112] 0 0
Hidalgo
Country [113] 0 0
Mexico
State/province [113] 0 0
Mexico City
Country [114] 0 0
Mexico
State/province [114] 0 0
Michoacán
Country [115] 0 0
Mexico
State/province [115] 0 0
Nuevo León
Country [116] 0 0
Mexico
State/province [116] 0 0
Oaxaca City
Country [117] 0 0
Netherlands
State/province [117] 0 0
South Holland
Country [118] 0 0
Netherlands
State/province [118] 0 0
Utrecht
Country [119] 0 0
Peru
State/province [119] 0 0
Lambayeque
Country [120] 0 0
Peru
State/province [120] 0 0
Muni Metro de Lima
Country [121] 0 0
Peru
State/province [121] 0 0
Lima
Country [122] 0 0
Poland
State/province [122] 0 0
Masovian Voivodeship
Country [123] 0 0
Poland
State/province [123] 0 0
Pomeranian Voivodeship
Country [124] 0 0
Poland
State/province [124] 0 0
Silesian Voivodeship
Country [125] 0 0
Poland
State/province [125] 0 0
Warmian-Masurian Voivodeship
Country [126] 0 0
Portugal
State/province [126] 0 0
Braga
Country [127] 0 0
Portugal
State/province [127] 0 0
Porto
Country [128] 0 0
Puerto Rico
State/province [128] 0 0
Mayagüez
Country [129] 0 0
Puerto Rico
State/province [129] 0 0
San Juan
Country [130] 0 0
Romania
State/province [130] 0 0
Bucure?ti
Country [131] 0 0
Romania
State/province [131] 0 0
Cluj
Country [132] 0 0
Romania
State/province [132] 0 0
Brasov
Country [133] 0 0
Romania
State/province [133] 0 0
Sibiu
Country [134] 0 0
Singapore
State/province [134] 0 0
Central Singapore
Country [135] 0 0
South Africa
State/province [135] 0 0
Gauteng
Country [136] 0 0
South Africa
State/province [136] 0 0
Western Cape
Country [137] 0 0
South Korea
State/province [137] 0 0
Kyonggi-do
Country [138] 0 0
South Korea
State/province [138] 0 0
Pusan-Kwangyokshi
Country [139] 0 0
South Korea
State/province [139] 0 0
Taejon-Kwangyokshi
Country [140] 0 0
South Korea
State/province [140] 0 0
Seoul
Country [141] 0 0
Spain
State/province [141] 0 0
Andalusia
Country [142] 0 0
Spain
State/province [142] 0 0
Barcelona
Country [143] 0 0
Spain
State/province [143] 0 0
Las Palmas
Country [144] 0 0
Spain
State/province [144] 0 0
Valenciana, Comunitat
Country [145] 0 0
Spain
State/province [145] 0 0
Madrid
Country [146] 0 0
Spain
State/province [146] 0 0
Málaga
Country [147] 0 0
Spain
State/province [147] 0 0
Zaragoza
Country [148] 0 0
Switzerland
State/province [148] 0 0
Canton of Aargau
Country [149] 0 0
Switzerland
State/province [149] 0 0
Canton of St. Gallen
Country [150] 0 0
Switzerland
State/province [150] 0 0
Canton Ticino
Country [151] 0 0
Taiwan
State/province [151] 0 0
Taoyuan
Country [152] 0 0
Taiwan
State/province [152] 0 0
Kaohsiung City
Country [153] 0 0
Taiwan
State/province [153] 0 0
Tainan City
Country [154] 0 0
Taiwan
State/province [154] 0 0
Taipei
Country [155] 0 0
Thailand
State/province [155] 0 0
Bangkok
Country [156] 0 0
Thailand
State/province [156] 0 0
Chiang Mai
Country [157] 0 0
Turkey (Türkiye)
State/province [157] 0 0
Samsun
Country [158] 0 0
Turkey (Türkiye)
State/province [158] 0 0
Tekirdas
Country [159] 0 0
Turkey (Türkiye)
State/province [159] 0 0
Adana
Country [160] 0 0
Turkey (Türkiye)
State/province [160] 0 0
Ankara
Country [161] 0 0
Turkey (Türkiye)
State/province [161] 0 0
Antalya
Country [162] 0 0
Turkey (Türkiye)
State/province [162] 0 0
Istanbul
Country [163] 0 0
Ukraine
State/province [163] 0 0
Cherkasy Oblast
Country [164] 0 0
Ukraine
State/province [164] 0 0
Ivano-Frankivsk Oblast
Country [165] 0 0
Ukraine
State/province [165] 0 0
Khmelnytskyi Oblast
Country [166] 0 0
Ukraine
State/province [166] 0 0
Lviv Oblast
Country [167] 0 0
Ukraine
State/province [167] 0 0
Kyiv

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://externaldatasharing-msd.com/


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06717347