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Clinical Trials in the USA / NCT06890884
Recruiting Phase 2

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)

NCT06890884 · tracked via the Priya Life Science USA tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 2
Started
2025-04-11
Last updated
2026-09-11

Condition(s) studied

Lymphoma, Large B-Cell, Diffuse

Investigational drug(s) / intervention(s)

Zilovertamab vedotin →Rituximab →Cyclophosphamide →Doxorubicin →Rituximab Biosimilar →Prednisone →Prednisolone →Polatuzumab vedotin →Rescue Medication

Zilovertamab vedotin: IV infusion

Rituximab: IV infusion

Cyclophosphamide: IV infusion

Doxorubicin: IV infusion

Rituximab Biosimilar: IV infusion

Prednisone: Oral administration or IV infusion

Prednisolone: Oral administration or IV infusion

Polatuzumab vedotin: IV infusion

Rescue Medication: Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medication is Granulocyte Colony-Stimulating Factor (G-CSF).

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (144)

FacilityCityRegionStatus
Infirmary Cancer Care ( Site 0157) Mobile Alabama Recruiting
Ironwood Cancer & Research Centers ( Site 0204) Chandler Arizona Recruiting
Palo Verde Cancer Specialists ( Site 0105) Glendale Arizona Recruiting
City of Hope - Phoenix ( Site 0202) Goodyear Arizona Recruiting
Genesis Cancer and Blood Institute ( Site 0193) Hot Springs Arkansas Recruiting
Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0135) Burbank California Recruiting
City of Hope Comprehensive Cancer Center ( Site 0191) Duarte California Recruiting
Bass Medical Group ( Site 0123) Walnut Creek California Recruiting
Rocky Mountain Cancer Centers (RMCC) ( Site 8001) Aurora Colorado Recruiting
Colorado West Healthcare System-Grand Valley Oncology ( Site 0165) Grand Junction Colorado Recruiting
Medical Oncology Hematology Consultants (MOHC) ( Site 8007) Newark Delaware Recruiting
Georgetown University Medical Center ( Site 0117) Washington D.C. District of Columbia Recruiting
Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0130) Boca Raton Florida Recruiting
Baptist MD Anderson Cancer Center ( Site 0176) Jacksonville Florida Recruiting
Mount Sinai Braman Comprehensive Cancer Center ( Site 0140) Miami Beach Florida Recruiting
Mid Florida Hematology and Oncology Center ( Site 0152) Orange City Florida Recruiting
Beacon Cancer Care ( Site 0142) Post Falls Idaho Recruiting
University of Chicago Medical Center ( Site 0126) Chicago Illinois Recruiting
Illinois Cancer Care ( Site 7005) Peoria Illinois Recruiting
University of Iowa-Holden Comprehensive Cancer Center ( Site 0139) Iowa City Iowa Recruiting
Mission Blood & Cancer Care ( Site 0114) Waukee Iowa Recruiting
Saint Elizabeth Medical Center Edgewood ( Site 0141) Edgewood Kentucky Recruiting
Baptist Health Hardin ( Site 0154) Elizabethtown Kentucky Recruiting
Baptist Health Lexington ( Site 0127) Lexington Kentucky Recruiting
Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0185) Louisville Kentucky Recruiting
Our Lady of the Lake Physician Group-Medical Oncology ( Site 0180) Baton Rouge Louisiana Recruiting
Ochsner LSU Health - Monroe Medical Center, Family Medicine Clinic ( Site 0209) Monroe Louisiana Recruiting
Ochsner Clinic Foundation ( Site 0189) New Orleans Louisiana Recruiting
Louisiana State University Health Sciences Shreveport ( Site 0195) Shreveport Louisiana Recruiting
Beth Israel Deaconess Medical Center ( Site 0161) Boston Massachusetts Recruiting
Dana Farber Cancer Institute ( Site 0111) Boston Massachusetts Recruiting
Minnesota Oncology Hematology (MNO) ( Site 8004) Burnsville Minnesota Recruiting
Bozeman Health Deaconess Hospital ( Site 0183) Bozeman Montana Recruiting
NHO Revive Research Institute, LLC ( Site 0121) Lincoln Nebraska Recruiting
University Of Nebraska Medical Center ( Site 0110) Omaha Nebraska Recruiting
Atlantic Health Morristown Medical Center ( Site 0163) Morristown New Jersey Recruiting
Valley Health Systems - Ridgewood Campus ( Site 0125) Paramus New Jersey Recruiting
Erie County Medical Center ( Site 0175) Buffalo New York Completed
Roswell Park Cancer Institute ( Site 0192) Buffalo New York Recruiting
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0208) Mineola New York Recruiting

+ 104 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 the USA

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 NCT06890884 on ClinicalTrials.gov ↗ ← All trials in the USA