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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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).
  • Biological: Zilovertamab vedotin
    IV infusion
    Other names:
    • MK-2140
    • VLS-101
  • Biological: Rituximab
    IV infusion
    Other names:
    • RITUXAN®
  • Drug: Cyclophosphamide
    IV infusion
    Other names:
    • CYTOXAN®
    • NEOSAR®
  • Drug: Doxorubicin
    IV infusion
    Other names:
    • ADRIAMYCIN®
  • Biological: Rituximab Biosimilar
    IV infusion
    Other names:
    • TRUXIMA®
    • RUXIENCE®
    • RIABNI®
  • Drug: Prednisone
    Per Approved Product Label
  • Drug: Prednisolone
    Oral administration
  • Drug: 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).
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).
  • Biological: Rituximab
    IV infusion
    Other names:
    • RITUXAN®
  • Drug: Cyclophosphamide
    IV infusion
    Other names:
    • CYTOXAN®
    • NEOSAR®
  • Drug: Doxorubicin
    IV infusion
    Other names:
    • ADRIAMYCIN®
  • Biological: Rituximab Biosimilar
    IV infusion
    Other names:
    • TRUXIMA®
    • RUXIENCE®
    • RIABNI®
  • Drug: Prednisone
    Per Approved Product Label
  • Drug: Prednisolone
    Oral administration
  • Drug: Vincristine
    IV infusion

Recruiting Locations

The University of Arizona Cancer Center - North Campus ( Site 0124)
Tucson 5318313, Arizona 5551752 85719
Contact:
Study Coordinator
520-621-5497

Cancer Blood and Specialty Clinic ( Site 0109)
Los Alamitos 5368304, California 5332921 90720
Contact:
Study Coordinator
562-200-0203

Cedars-Sinai Medical Center ( Site 0115)
Los Angeles 5368361, California 5332921 90048
Contact:
Study Coordinator
310-423-3277

Pacific Hematology Oncology Associates ( Site 0131)
San Francisco 5391959, California 5332921 94115
Contact:
Study Coordinator
415-923-3012

Bioresearch Partner ( Site 0157)
Hialeah 4158476, Florida 4155751 33013
Contact:
Study Coordinator
833-489-4968

Cancer Care Specialists of Illinois ( Site 0152)
O'Fallon 4245926, Illinois 4896861 62269
Contact:
Study Coordinator
618-416-7970

Fort Wayne Medical Oncology and Hematology ( Site 0149)
Fort Wayne 4920423, Indiana 4921868 46804
Contact:
Study Coordinator
260-436-0800

Cotton O'Neil Cancer Center ( Site 0108)
Topeka 4280539, Kansas 4273857 66606
Contact:
Study Coordinator
785-478-9495

University of Kentucky ( Site 0106)
Lexington 4297983, Kentucky 6254925 40536
Contact:
Study Coordinator
859-257-6006

Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0163)
Louisville 4299276, Kentucky 6254925 40207
Contact:
Study Coordinator
502-899-3366

Corewell Health ( Site 0130)
Grand Rapids 4994358, Michigan 5001836 49503
Contact:
Study Coordinator
616-486-6180

Truman Medical Center ( Site 0122)
Kansas City 4393217, Missouri 4398678 64108
Contact:
Study Coordinator
816-404-4418

OptumCare Cancer Care ( Site 0121)
Las Vegas 5506956, Nevada 5509151 89102
Contact:
Study Coordinator
702-724-8787

Comprehensive Cancer Centers of Nevada ( Site 0113)
Las Vegas 5506956, Nevada 5509151 89169
Contact:
Study Coordinator
702-622-9699

New York Oncology Hematology, P.C. ( Site 0129)
Albany 5106834, New York 5128638 12206
Contact:
Study Coordinator
518-262-6696

Sanford Cancer Center ( Site 0143)
Sioux Falls 5231851, South Dakota 5769223 57104
Contact:
Study Coordinator
605-328-8000

The University of Tennessee Medical Center ( Site 0142)
Knoxville 4634946, Tennessee 4662168 37920
Contact:
Study Coordinator
865-305-9000

Center for Oncology and Blood Disorders ( Site 0153)
Houston 4699066, Texas 4736286 77030
Contact:
Study Coordinator
713-301-8964

Houston Methodist Cancer Center ( Site 0154)
Houston 4699066, Texas 4736286 77030
Contact:
Study Coordinator
713-363-8009

University of Virginia Cancer Center ( Site 0138)
Charlottesville 4752031, Virginia 6254928 22903
Contact:
Study Coordinator
434-243-7773

Virginia Cancer Institute ( Site 0148)
Richmond 4781708, Virginia 6254928 23229
Contact:
Study Coordinator
888-577-8839

Blue Ridge Cancer Care ( Site 0132)
Roanoke 4782167, Virginia 6254928 24014
Contact:
Study Coordinator
540-982-0237

SSM Health Dean Medical Group ( Site 0140)
Madison 5261457, Wisconsin 5279468 53715
Contact:
Study Coordinator
608-410-2700

BRCR Global - Mayaguez ( Site 1003)
Mayagüez 4566385, Puerto Rico 00682
Contact:
Study Coordinator
1 561 437 6038

Auxilio Mutuo Cancer Center ( Site 1001)
San Juan 4568127, Puerto Rico 00918
Contact:
Study Coordinator
787 758 2000

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.