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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
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, prednisolone, or methylprednisolone 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 per approved product label. The rescue medication is granulocyte colony-stimulating factor (G-CSF).
  • Drug: Methylprednisolone
    Per Approved Product Label
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, prednisolone, or methylprednisolone 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
  • Drug: Methylprednisolone
    Per Approved Product Label

Recruiting Locations

Banner MD Anderson Cancer Center ( Site 0165)
Gilbert, Arizona 85234
Contact:
Study Coordinator
480-256-6444

Banner MD Anderson Cancer Center - University Medical Center Phoenix ( Site 0167)
Phoenix, Arizona 85006
Contact:
Study Coordinator
480-256-6444

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

Providence Medical Foundation-Oncology ( Site 0168)
Fullerton, California 92835
Contact:
Study Coordinator
714-446-5900

MemorialCare Health System - Long Beach Medical Center ( Site 9559)
Long Beach, California 90806
Contact:
Study Coordinator
652-241-9755

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

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

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

Lutheran Hospital - Cancer Centers of Colorado ( Site 0180)
Golden, Colorado 80401
Contact:
Study Coordinator
303-403-6381

Clermont Oncology Center ( Site 0182)
Clermont, Florida 34711
Contact:
Study Coordinator
352-242-1366

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

Orlando Health Cancer Institute ( Site 0169)
Ocoee, Florida 34761
Contact:
Study Coordinator
321-843-7497

Mid Florida Hematology and Oncology Center ( Site 0172)
Orange City, Florida 32763
Contact:
Study Coordinator
386-774-1223

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

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

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

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

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

Owensboro Medical Health System ( Site 0195)
Owensboro, Kentucky 42303
Contact:
Study Coordinator
270-688-1938

CHRISTUS St. Frances Cabrini Hospital Center for Cancer Care ( Site 0184)
Alexandria, Louisiana 71301
Contact:
Study Coordinator
318-448-6917

American Oncology Partners, P.A. ( Site 0185)
Bethesda, Maryland 20817
Contact:
Study Coordinator
301-571-2016

Karmanos Cancer Institute ( Site 0174)
Detroit, Michigan 48201
Contact:
Study Coordinator
800-527-6266

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

The University of Mississippi Medical Center ( Site 0161)
Jackson, Mississippi 39216
Contact:
Study Coordinator
601-984-5601

Circuit Clinical - SSM Health Cancer Care DePaul ( Site 0166)
Bridgeton, Missouri 63044
Contact:
Study Coordinator
636-673-3083

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

Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0178)
Billings, Montana 59102
Contact:
Study Coordinator
406-238-6685

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

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

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

Icahn School of Medicine at Mount Sinai ( Site 0164)
New York, New York 10029
Contact:
Study Coordinator
212-241-6500

East Carolina University ( Site 0159)
Greenville, North Carolina 27834
Contact:
Study Coordinator
252-816-2273

Sanford Health Roger Maris Cancer Center ( Site 0189)
Fargo, North Dakota 58102
Contact:
Study Coordinator
701-234-6161

Prisma Health - Upstate ( Site 0158)
Greenville, South Carolina 29605
Contact:
Study Coordinator
864-679-3900

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

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

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

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

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

Virginia Cancer Institute ( Site 0148)
Richmond, Virginia 23229
Contact:
Study Coordinator
804-287-3000

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

Vista Oncology ( Site 4201)
Olympia, Washington 98506
Contact:
Study Coordinator
360-413-8880

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

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

BRCR Global Puerto Rico - Caribbean Cancer Care ( Site 1003)
Yauco, Puerto Rico 00698
Contact:
Study Coordinator
1 561 437 6038

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.