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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
Phase 2
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 will 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 3-week cycle for up to 6 cycles (up to approximately 4 months) plus 2 additional cycles of rituximab or biosimilar for participants with high risk DLBCL. Participants will also receive 100 mg prednisone or prednisolone via oral tablet per day during Days 1-5 of each 3-week 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
    Oral administration or IV infusion
  • Drug: Prednisolone
    Oral administration or IV infusion
  • Drug: Rescue Medication
    Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medication is Granulocyte Colony-Stimulating Factor (G-CSF).
Active Comparator
Polatuzumab vedotin + R-CHP 		Participants will receive a dose of polatuzumab vedotin (1.8 mg/kg) plus 750 mg/m^2 cyclophosphamide, 50 mg/m^2 doxorubicin, and 375 mg/m^2 rituximab or rituximab biosimilar administered by IV infusion on Day 1 of each 3-week cycle for up to 6 cycles (up to approximately 4 months) plus 2 additional cycles of rituximab or biosimilar for participants with high risk DLBCL. Participants will also receive 100 mg prednisone or prednisolone via oral tablet per day during Days 1-5 of each 3-week 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
    Oral administration or IV infusion
  • Drug: Prednisolone
    Oral administration or IV infusion
  • Biological: Polatuzumab vedotin
    IV infusion
  • Drug: Rescue Medication
    Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medication is Granulocyte Colony-Stimulating Factor (G-CSF).

Recruiting Locations

Infirmary Cancer Care ( Site 0157)
Mobile, Alabama 36607
Contact:
Study Coordinator
251-435-2273

Palo Verde Cancer Specialists ( Site 0105)
Glendale, Arizona 85304
Contact:
Study Coordinator
602-978-6255

Genesis Cancer and Blood Institute ( Site 0193)
Hot Springs, Arkansas 71913
Contact:
Study Coordinator
501-624-7700

Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0135)
Burbank, California 91505
Contact:
Study Coordinator
818-840-0921

City of Hope Comprehensive Cancer Center ( Site 0191)
Duarte, California 91010
Contact:
Study Coordinator
626-218-2405

Bass Medical Group ( Site 0123)
Walnut Creek, California 94598
Contact:
Study Coordinator
925-433-8786

Rocky Mountain Cancer Centers (RMCC) ( Site 8001)
Aurora, Colorado 80012
Contact:
Study Coordinator
303-925-0700

Colorado West Healthcare System-Grand Valley Oncology ( Site 0165)
Grand Junction, Colorado 81505
Contact:
Study Coordinator
970-644-4460

Medical Oncology Hematology Consultants (MOHC) ( Site 8007)
Newark, Delaware 19713
Contact:
Study Coordinator
302-366-1200

Georgetown University Medical Center ( Site 0117)
Washington D.C., District of Columbia 20007
Contact:
Study Coordinator
202-444-2223

Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0130)
Boca Raton, Florida 33486
Contact:
Study Coordinator
561-955-4800

Baptist MD Anderson Cancer Center ( Site 0176)
Jacksonville, Florida 32207
Contact:
Study Coordinator
904-202-7300

Mount Sinai Cancer Center ( Site 0140)
Miami Beach, Florida 33140
Contact:
Study Coordinator
305-674-2625

Mid Florida Hematology and Oncology Center ( Site 0152)
Orange City, Florida 32763
Contact:
Study Coordinator
386-774-1223

Beacon Cancer Care ( Site 0142)
Post Falls, Idaho 83854
Contact:
Study Coordinator
208-755-2804

University of Chicago Medical Center ( Site 0126)
Chicago, Illinois 60637
Contact:
Study Coordinator
773-702-5550

Illinois Cancer Care ( Site 7005)
Peoria, Illinois 61615
Contact:
Study Coordinator
309-240-6040

University of Iowa-Holden Comprehensive Cancer Center ( Site 0139)
Iowa City, Iowa 52242
Contact:
Study Coordinator
319-356-4200

Mission Blood & Cancer Care ( Site 0114)
Waukee, Iowa 50263
Contact:
Study Coordinator
515-282-2921

Saint Elizabeth Medical Center Edgewood ( Site 0141)
Edgewood, Kentucky 41017
Contact:
Study Coordinator
859-301-2000

Baptist Health Hardin ( Site 0154)
Elizabethtown, Kentucky 42701
Contact:
Study Coordinator
270-706-5065

Baptist Health Lexington ( Site 0127)
Lexington, Kentucky 40503
Contact:
Study Coordinator
859-260-6100

Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0185)
Louisville, Kentucky 40207
Contact:
Study Coordinator
502-899-3366

Our Lady of the Lake Physician Group-Medical Oncology ( Site 0180)
Baton Rouge, Louisiana 70808
Contact:
Study Coordinator
225-374-0320

Ochsner LSU Health - Monroe Medical Center, Family Medicine Clinic ( Site 0209)
Monroe, Louisiana 71202
Contact:
Study Coordinator
318-330-0000

Ochsner Clinic Foundation ( Site 0189)
New Orleans, Louisiana 70121
Contact:
Study Coordinator
504-703-1340

Louisiana State University Health Sciences Shreveport ( Site 0195)
Shreveport, Louisiana 71103
Contact:
Study Coordinator
318-813-1057

Minnesota Oncology Hematology (MNO) ( Site 8004)
Burnsville, Minnesota 55337
Contact:
Study Coordinator
952-892-7190

Bozeman Health Deaconess Hospital ( Site 0183)
Bozeman, Montana 59715
Contact:
Study Coordinator
406-414-3749

NHO Revive Research Institute, LLC ( Site 0121)
Lincoln, Nebraska 68506
Contact:
Study Coordinator
402-484-4900

University Of Nebraska Medical Center ( Site 0110)
Omaha, Nebraska 68198
Contact:
Study Coordinator
402-559-5600

Atlantic Health Morristown Medical Center ( Site 0163)
Morristown, New Jersey 07960
Contact:
Study Coordinator
973-971-6608

Valley Health Systems - Ridgewood Campus ( Site 0125)
Paramus, New Jersey 07652
Contact:
Study Coordinator
201-447-8000

Erie County Medical Center ( Site 0175)
Buffalo, New York 14215
Contact:
Study Coordinator
716-898-1880

Roswell Park Cancer Institute ( Site 0192)
Buffalo, New York 14263
Contact:
Study Coordinator
716-845-2300

Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0208)
Mineola, New York 11501
Contact:
Study Coordinator
516-663-2988

Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0108)
New York, New York 10016
Contact:
Study Coordinator
212-731-6000

SUNY Upstate Cancer Center ( Site 0178)
Syracuse, New York 13210
Contact:
Study Coordinator
315-464-8200

Clinical Research Alliance ( Site 0122)
Westbury, New York 11590
Contact:
Study Coordinator
646-872-8630

University of North Carolina Medical Center ( Site 0136)
Chapel Hill, North Carolina 27514
Contact:
Study Coordinator
984-974-1000

Novant Health Presbyterian Medical Center ( Site 0177)
Charlotte, North Carolina 28204
Contact:
Study Coordinator
704-384-4000

Novant Health Forsyth Medical Center ( Site 0206)
Winston-Salem, North Carolina 27103
Contact:
Study Coordinator
336-718-5000

University of Cincinnati Medical Center ( Site 0156)
Cincinnati, Ohio 45219
Contact:
Study Coordinator
513-584-1000

University Hospitals of Cleveland ( Site 0155)
Cleveland, Ohio 44106
Contact:
Study Coordinator
216-286-3867

Fairview Hospital-Moll Cancer Center ( Site 0198)
Cleveland, Ohio 44111
Contact:
Study Coordinator
216-444-6833

Cleveland Clinic Main ( Site 0101)
Cleveland, Ohio 44195
Contact:
Study Coordinator
216-444-6833

Cleveland Clinic - Hillcrest Hospital-Hillcrest Hospital Cancer Center ( Site 0199)
Mayfield Heights, Ohio 44124
Contact:
Study Coordinator
216-444-6833

Providence Portland Medical Center ( Site 0120)
Portland, Oregon 97213
Contact:
Study Coordinator
503-216-6300

Providence Oncology and Hematology Clinic Westside ( Site 0179)
Portland, Oregon 97225
Contact:
Study Coordinator
503-216-6300

Temple University Hospital ( Site 0133)
Philadelphia, Pennsylvania 19140
Contact:
Study Coordinator
215-707-8712

Alliance Cancer Specialists (ACS) ( Site 8010)
Sellersville, Pennsylvania 18960
Contact:
Study Coordinator
215-706-2034

Cancer Care Associates Of York ( Site 0174)
York, Pennsylvania 17403
Contact:
Study Coordinator
484-371-5102

Medical University of South Carolina ( Site 0153)
Charleston, South Carolina 29425
Contact:
Study Coordinator
843-792-2529

Tennessee Cancer Specialists ( Site 7004)
Knoxville, Tennessee 37909
Contact:
Study Coordinator
865-862-0998

SCRI Oncology Partners ( Site 7002)
Nashville, Tennessee 37203
Contact:
Study Coordinator
615-329-7274

Texas Oncology - West Texas ( Site 8008)
Amarillo, Texas 79124
Contact:
Study Coordinator
806-358-8654

Texas Oncology - Central/South Texas ( Site 8006)
Austin, Texas 78705
Contact:
Study Coordinator
512-427-9400

Texas Oncology - Northeast Texas ( Site 8002)
Palestine, Texas 75801
Contact:
Study Coordinator
903-727-2200

Texas Oncology - San Antonio ( Site 8009)
San Antonio, Texas 78240
Contact:
Study Coordinator
210-595-5300

The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0145)
Tyler, Texas 75701
Contact:
Study Coordinator
903-592-6152

Intermountain Medical Center ( Site 0182)
Murray, Utah 84107
Contact:
Study Coordinator
801-507-3630

Intermountain Healthcare - St. George ( Site 0203)
St. George, Utah 84790
Contact:
Study Coordinator
801-507-3630

Virginia Cancer Specialists, PC ( Site 8003)
Manassas, Virginia 20110
Contact:
Study Coordinator
703-554-6800

VCU Health Adult Outpatient Pavillion ( Site 0138)
Richmond, Virginia 23219
Contact:
Study Coordinator
315-383-8748

Northwest Cancer Specialists (Compass Oncology) ( Site 8000)
Vancouver, Washington 98684
Contact:
Study Coordinator
360-944-9889

SSM Health Dean Medical Group ( Site 0106)
Madison, Wisconsin 53715
Contact:
Study Coordinator
608-252-8000

Medical College of Wisconsin ( Site 0103)
Milwaukee, Wisconsin 53226
Contact:
Study Coordinator
414-805-6700

More Details

NCT ID
NCT06890884
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.

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