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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 Italy tracker
Phase
Phase 2
Started
2025-04-11
Last updated
2026-09-25

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)

  • Complete Response Rate (CRR) at End of Treatment (EOT) per Lugano Response Criteria — Up to approximately 31 months
    CRR at EOT is defined as the percentage of participants who experience complete response (CR) per Lugano response criteria as assessed by blinded independent central review (BICR) at end of treatment. CR is complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. Participants with missing data or who discontinue treatment or study prior to reaching EOT will be considered non-responders and included in the total number of participants.

Trial sites (146)

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

+ 106 more sites — see the full list on the official registry below.

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 Italy