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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Zilovertamab vedotin, Rituximab, Cyclophosphamide, Doxorubicin.
- Who it may be relevant to
- Registry conditions: Diffuse Large B-Cell Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Australia, Belgium, Brazil +30
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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)
Overview
The purpose of this study is to evaluate if zilovertamab vedotin with standard treatment can help people live longer without the cancer growing or spreading than people who receive standard treatment alone.
Interventions
- Biological Zilovertamab vedotin
IV infusion - Biological Rituximab
IV infusion - Drug Cyclophosphamide
IV infusion - Drug Doxorubicin
IV infusion - Biological Rituximab Biosimilar
IV infusion - Drug Prednisone
Per Approved Product Label - Drug Prednisolone
Oral administration - Drug Vincristine
IV infusion - Drug Rescue medication
Participants receive rescue medication per approved product label. The rescue medication is granulocyte colony-stimulating factor (G-CSF). - Drug Methylprednisolone
Per Approved Product Label
Primary outcome measures
- Progression-free survival (PFS) [Time frame: Up to ~ 50 months]
Secondary outcome measures (10)
- Complete Response at End of Treatment (CR at EOT) [Time frame: Up to ~ 32 months]
- Overall Survival (OS) [Time frame: Up to ~ 74 months]
- Event-free Survival (EFS) [Time frame: Up to ~ 74 months]
- Duration of Complete Response (DurCR) [Time frame: Up to ~ 74 months]
- Number of Participants Who Experience an Adverse Event (AE) [Time frame: Up to ~ 9 months]
- Number of Participants Who Discontinue Study Treatment Due to an AE [Time frame: Up to ~ 6 months]
- Change From Baseline in Health-Related Quality Of Life (HRQoL) on Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Trial Outcome Index (TOI) Score [Time frame: Baseline and Week 25]
- Change From Baseline in HRQoL on FACT-Lym Total Score [Time frame: Baseline and Week 25]
- Change From Baseline in HRQoL on FACT-Lym Physical Wellbeing (PWB) Score [Time frame: Baseline and Week 25]
- Change From Baseline in HRQoL on Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) Neurotoxicity Subscale Score [Time frame: Baseline and Week 25]
Eligibility criteria
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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 46 centers
- USA Mitchell Cancer Institute ( Site 0173) — Mobile
- Banner MD Anderson Cancer Center ( Site 0165) — Gilbert
- Banner MD Anderson Cancer Center - University Medical Center Phoenix ( Site 0167) — Phoenix
- The University of Arizona Cancer Center - North Campus ( Site 0124) — Tucson
- Providence Medical Foundation-Oncology ( Site 0168) — Fullerton
- MemorialCare Health System - Long Beach Medical Center ( Site 9559) — Long Beach
- Cancer Blood and Specialty Clinic ( Site 0109) — Los Alamitos
- Cedars-Sinai Medical Center ( Site 0115) — Los Angeles
- … and 38 more centers
China · 24 centers
Center list to be confirmed — check the primary protocol.
Japan · 20 centers
Center list to be confirmed — check the primary protocol.
France · 14 centers
Center list to be confirmed — check the primary protocol.
Spain · 12 centers
Center list to be confirmed — check the primary protocol.
Italy · 11 centers
Center list to be confirmed — check the primary protocol.
Brazil · 9 centers
- CEONC ( Site 0412) — Cascavel
- Hospital Erasto Gaertner ( Site 0401) — Curitiba
- Liga Norte Riograndense Contra o Cancer ( Site 0407) — Natal
- CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0403) — Florianópolis
- Hope ( Site 0413) — Ribeirão Preto
- Clinica Advanze ( Site 0411) — São Carlos
- F. F. R. M. São Jose do Rio Preto ( Site 0404) — SJRP
- Hospital Paulistano ( Site 0406) — São Paulo
- … and 1 more center
Chile · 9 centers
- Biocenter ( Site 0510) — Concepción
- IC La Serena Research ( Site 0504) — La Serena
- Oncocentro Valdivia ( Site 0506) — Valdivia
- Centro de Estudios Clínicos SAGA ( Site 0508) — Santiago
- FALP ( Site 0501) — Santiago
- … and 4 more centers
Argentina · 8 centers
- Clinica Adventista Belgrano ( Site 0309) — Caba.
- Instituto de Investigaciones Clinicas Mar del Plata ( Site 0306) — Mar del Plata
- Hospital Universitario Austral ( Site 0307) — Pilar
- Hospital Aleman ( Site 0301) — Buenos Aires
- Fundacion Estudios Clinicos ( Site 0311) — Rosario
- C.I.C.E. 9 de Julio ( Site 0305) — San Miguel de Tucumán
- Hospital Italiano de Buenos Aires ( Site 0304) — CABA
- Clinica EL Castaño ( Site 0312) — San Juan
Turkey (Türkiye) · 8 centers
Center list to be confirmed — check the primary protocol.
Mexico · 7 centers
Center list to be confirmed — check the primary protocol.
Poland · 7 centers
Center list to be confirmed — check the primary protocol.
South Korea · 7 centers
Center list to be confirmed — check the primary protocol.
Ukraine · 7 centers
Center list to be confirmed — check the primary protocol.
Taiwan · 6 centers
Center list to be confirmed — check the primary protocol.
Australia · 5 centers
- Townsville University Hospital ( Site 3006) — Townsville
- Royal Adelaide Hospital ( Site 3001) — Adelaide
- Grampians Health ( Site 3003) — Ballarat
- Northern Hospital ( Site 3002) — Melbourne
- Royal Perth Hospital-Haematology ( Site 3004) — Perth
Canada · 5 centers
- Cross Cancer Institute ( Site 0205) — Edmonton
- Queen Elizabeth II Health Sciences Centre ( Site 0207) — Halifax
- Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0208) — Hamilton
- Lakeridge Health - The R.S. McLaughlin Durham Regional Cancer Centre (MDRCC) ( Site 0206) — Oshawa
- Sunnybrook Research Institute ( Site 0204) — Toronto
Colombia · 5 centers
Center list to be confirmed — check the primary protocol.
Hungary · 5 centers
Center list to be confirmed — check the primary protocol.
Malaysia · 5 centers
Center list to be confirmed — check the primary protocol.
Peru · 5 centers
Center list to be confirmed — check the primary protocol.
Denmark · 4 centers
Center list to be confirmed — check the primary protocol.
Greece · 4 centers
Center list to be confirmed — check the primary protocol.
Israel · 4 centers
Center list to be confirmed — check the primary protocol.
Romania · 4 centers
Center list to be confirmed — check the primary protocol.
South Africa · 4 centers
Center list to be confirmed — check the primary protocol.
Switzerland · 4 centers
Center list to be confirmed — check the primary protocol.
Guatemala · 3 centers
Center list to be confirmed — check the primary protocol.
Portugal · 3 centers
Center list to be confirmed — check the primary protocol.
Thailand · 3 centers
Center list to be confirmed — check the primary protocol.
Belgium · 2 centers
- AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 1102) — Mechelen
- ASBL CHU Helora - Hôpital de Mons - Site Kennedy ( Site 1103) — Mons
Hong Kong · 2 centers
Center list to be confirmed — check the primary protocol.
Netherlands · 2 centers
Center list to be confirmed — check the primary protocol.
Puerto Rico · 2 centers
Center list to be confirmed — check the primary protocol.
Singapore · 2 centers
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06717347 · 2140-010 · MK-2140-010 · 2024-515566-13-00 · U1111-1309-3971 · jRCT2061240099