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Clinical Trials in China / NCT06717347
Recruiting Phase 3

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)

NCT06717347 · tracked via the Priya Life Science China tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 3
Started
2025-01-27
Last updated
2026-09-11

Condition(s) studied

Diffuse Large B-Cell Lymphoma

Investigational drug(s) / intervention(s)

Zilovertamab vedotinRituximabCyclophosphamideDoxorubicinRituximab BiosimilarPrednisonePrednisoloneVincristineRescue medicationMethylprednisolone

Zilovertamab vedotin: IV infusion

Rituximab: IV infusion

Cyclophosphamide: IV infusion

Doxorubicin: IV infusion

Rituximab Biosimilar: IV infusion

Prednisone: Per Approved Product Label

Prednisolone: Oral administration

Vincristine: IV infusion

Rescue medication: Participants receive rescue medication per approved product label. The rescue medication is granulocyte colony-stimulating factor (G-CSF).

Methylprednisolone: Per Approved Product Label

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (272)

FacilityCityRegionStatus
USA Mitchell Cancer Institute ( Site 0173) Mobile Alabama Recruiting
Banner MD Anderson Cancer Center ( Site 0165) Gilbert Arizona Recruiting
Banner MD Anderson Cancer Center - University Medical Center Phoenix ( Site 0167) Phoenix Arizona Recruiting
The University of Arizona Cancer Center - North Campus ( Site 0124) Tucson Arizona Recruiting
Providence Medical Foundation-Oncology ( Site 0168) Fullerton California Recruiting
MemorialCare Health System - Long Beach Medical Center ( Site 9559) Long Beach California Recruiting
Cancer Blood and Specialty Clinic ( Site 0109) Los Alamitos California Recruiting
Cedars-Sinai Medical Center ( Site 0115) Los Angeles California Recruiting
Pacific Hematology Oncology Associates ( Site 0131) San Francisco California Recruiting
Lutheran Hospital - Cancer Centers of Colorado ( Site 0180) Golden Colorado Recruiting
Clermont Oncology Center ( Site 0182) Clermont Florida Recruiting
Bioresearch Partner ( Site 0157) Hialeah Florida Recruiting
Orlando Health Cancer Institute ( Site 0169) Ocoee Florida Recruiting
Mid Florida Hematology and Oncology Center ( Site 0172) Orange City Florida Recruiting
University Cancer & Blood Center, LLC ( Site 0141) Athens Georgia Recruiting
Cancer Care Specialists of Illinois ( Site 0152) O'Fallon Illinois Recruiting
Fort Wayne Medical Oncology and Hematology ( Site 0149) Fort Wayne Indiana Recruiting
Cotton O'Neil Cancer Center ( Site 0108) Topeka Kansas Recruiting
University of Kentucky ( Site 0106) Lexington Kentucky Recruiting
Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0163) Louisville Kentucky Recruiting
Owensboro Medical Health System ( Site 0195) Owensboro Kentucky Recruiting
CHRISTUS St. Frances Cabrini Hospital Center for Cancer Care ( Site 0184) Alexandria Louisiana Recruiting
American Oncology Partners, P.A. ( Site 0185) Bethesda Maryland Recruiting
Karmanos Cancer Institute ( Site 0174) Detroit Michigan Recruiting
Corewell Health ( Site 0130) Grand Rapids Michigan Recruiting
The University of Mississippi Medical Center ( Site 0161) Jackson Mississippi Recruiting
Circuit Clinical - SSM Health Cancer Care DePaul ( Site 0166) Bridgeton Missouri Recruiting
Truman Medical Center ( Site 0122) Kansas City Missouri Recruiting
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0178) Billings Montana Recruiting
OptumCare Cancer Care ( Site 0121) Las Vegas Nevada Recruiting
Comprehensive Cancer Centers of Nevada ( Site 0113) Las Vegas Nevada Recruiting
Cancer Care Specialists ( Site 9582) Reno Nevada Recruiting
New York Oncology Hematology, P.C. ( Site 0129) Albany New York Recruiting
Icahn School of Medicine at Mount Sinai ( Site 0164) New York New York Recruiting
New York Cancer and Blood Specialists ( Site 9000) Shirley New York Recruiting
East Carolina University ( Site 0159) Greenville North Carolina Recruiting
Sanford Health Roger Maris Cancer Center ( Site 0189) Fargo North Dakota Recruiting
Kaiser Permanente Interstate Medical Office - Central ( Site 0181) Portland Oregon Recruiting
Prisma Health - Upstate ( Site 0158) Greenville South Carolina Recruiting
Sanford Cancer Center ( Site 0143) Sioux Falls South Dakota Recruiting

+ 232 more sites — see the full list on the official registry below.

On this site

📄 Rituxan (rituximab) drug profile → 📄 Deltasone (prednisone) drug profile →

More Merck Sharp & Dohme LLC trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06717347 on ClinicalTrials.gov ↗ ← All trials in China