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)

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

  • Lymphoma, Large B-Cell, Diffuse

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

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

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