A Randomized, Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Zilovertamab Vedotin (MK-2140) Plus R-CHP Versus Polatuzumab Vedotin Plus R-CHP in Treatment-naïve Participants With GCB Subtype of Diffuse Large B-cell Lymphoma (DLBCL)
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.
Arms & interventions
- BiologicalZilovertamab vedotin
IV infusion
- BiologicalRituximab
IV infusion
- DrugCyclophosphamide
IV infusion
- DrugDoxorubicin
IV infusion
- BiologicalRituximab Biosimilar
IV infusion
- DrugPrednisone
Oral administration or IV infusion
- DrugPrednisolone
Oral administration or IV infusion
- BiologicalPolatuzumab vedotin
IV infusion
- DrugRescue Medication
Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medication is Granulocyte Colony-Stimulating Factor (G-CSF).
Outcome measures
Primary
Complete Response Rate (CRR) at End of Treatment (EOT) per Lugano Response Criteria
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.
Time frame: Up to approximately 31 months
Secondary
Progression-free Survival (PFS) per Lugano Response Criteria
Time frame: Up to approximately 51 months
Overall Survival (OS)
Time frame: Up to approximately 87 months
Event-free Survival (EFS) per Lugano Response Criteria
Time frame: Up to approximately 51 months
Duration of CR
Time frame: Up to approximately 51 months
Number of participants who experience one or more adverse events (AEs)
Time frame: Up to approximately 9 months
Number of participants who discontinue study intervention due to an AE
Time frame: Up to approximately 6 months
Change From Baseline in Health-Related Quality Of Life (HRQoL) on Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Trial Outcome Index (TOI)
Time frame: Baseline and up to Week 25
Change From Baseline in HRQoL on FACT-Lym Total Score
Time frame: Baseline and up to Week 25
Change From Baseline in HRQoL on FACT-Lym Physical Well-being (PWB) (Items General Physical [GP]1 through GP7)
Time frame: Baseline and up to Week 25
Change From Baseline in HRQoL on Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) Neurotoxicity Subscale Score
Time frame: Baseline and up to Week 25
Eligibility criteria
Study locations (70)
Infirmary Cancer Care ( Site 0157)
Mobile, Alabama, 36607
Ironwood Cancer & Research Centers ( Site 0204)
Chandler, Arizona, 85224
Palo Verde Cancer Specialists ( Site 0105)
Glendale, Arizona, 85304
City of Hope - Phoenix ( Site 0202)
Goodyear, Arizona, 85338
Genesis Cancer and Blood Institute ( Site 0193)
Hot Springs, Arkansas, 71913
Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0135)
Burbank, California, 91505
City of Hope Comprehensive Cancer Center ( Site 0191)
Duarte, California, 91010
Bass Medical Group ( Site 0123)
Walnut Creek, California, 94598
Rocky Mountain Cancer Centers (RMCC) ( Site 8001)
Aurora, Colorado, 80012
Colorado West Healthcare System-Grand Valley Oncology ( Site 0165)
Grand Junction, Colorado, 81505
Medical Oncology Hematology Consultants (MOHC) ( Site 8007)
Newark, Delaware, 19713
Georgetown University Medical Center ( Site 0117)
Washington D.C., District of Columbia, 20007
Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0130)
Boca Raton, Florida, 33486
Baptist MD Anderson Cancer Center ( Site 0176)
Jacksonville, Florida, 32207
Mount Sinai Braman Comprehensive Cancer Center ( Site 0140)
Miami Beach, Florida, 33140
Mid Florida Hematology and Oncology Center ( Site 0152)
Orange City, Florida, 32763
Beacon Cancer Care ( Site 0142)
Post Falls, Idaho, 83854
University of Chicago Medical Center ( Site 0126)
Chicago, Illinois, 60637
Illinois Cancer Care ( Site 7005)
Peoria, Illinois, 61615
University of Iowa-Holden Comprehensive Cancer Center ( Site 0139)
Iowa City, Iowa, 52242
Mission Blood & Cancer Care ( Site 0114)
Waukee, Iowa, 50263
Saint Elizabeth Medical Center Edgewood ( Site 0141)
Edgewood, Kentucky, 41017
Baptist Health Hardin ( Site 0154)
Elizabethtown, Kentucky, 42701
Baptist Health Lexington ( Site 0127)
Lexington, Kentucky, 40503
Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0185)
Louisville, Kentucky, 40207
Our Lady of the Lake Physician Group-Medical Oncology ( Site 0180)
Baton Rouge, Louisiana, 70808
Ochsner LSU Health - Monroe Medical Center, Family Medicine Clinic ( Site 0209)
Monroe, Louisiana, 71202
Ochsner Clinic Foundation ( Site 0189)
New Orleans, Louisiana, 70121
Louisiana State University Health Sciences Shreveport ( Site 0195)
Shreveport, Louisiana, 71103
Dana Farber Cancer Institute ( Site 0111)
Boston, Massachusetts, 02215
Minnesota Oncology Hematology (MNO) ( Site 8004)
Burnsville, Minnesota, 55337
Bozeman Health Deaconess Hospital ( Site 0183)
Bozeman, Montana, 59715
NHO Revive Research Institute, LLC ( Site 0121)
Lincoln, Nebraska, 68506
University Of Nebraska Medical Center ( Site 0110)
Omaha, Nebraska, 68198
Atlantic Health Morristown Medical Center ( Site 0163)
Morristown, New Jersey, 07960
Valley Health Systems - Ridgewood Campus ( Site 0125)
Paramus, New Jersey, 07652
Erie County Medical Center ( Site 0175)
Buffalo, New York, 14215
Roswell Park Cancer Institute ( Site 0192)
Buffalo, New York, 14263
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0208)
Mineola, New York, 11501
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0108)
New York, New York, 10016
SUNY Upstate Cancer Center ( Site 0178)
Syracuse, New York, 13210
Clinical Research Alliance ( Site 0122)
Westbury, New York, 11590
University of North Carolina Medical Center ( Site 0136)
Chapel Hill, North Carolina, 27514
Novant Health Presbyterian Medical Center ( Site 0177)
Charlotte, North Carolina, 28204
Novant Health Forsyth Medical Center ( Site 0206)
Winston-Salem, North Carolina, 27103
University of Cincinnati Medical Center ( Site 0156)
Cincinnati, Ohio, 45219
University Hospitals of Cleveland ( Site 0155)
Cleveland, Ohio, 44106
Fairview Hospital-Moll Cancer Center ( Site 0198)
Cleveland, Ohio, 44111
Cleveland Clinic Main ( Site 0101)
Cleveland, Ohio, 44195
Cleveland Clinic - Hillcrest Hospital-Hillcrest Hospital Cancer Center ( Site 0199)
Mayfield Heights, Ohio, 44124
Providence Portland Medical Center ( Site 0120)
Portland, Oregon, 97213
Providence Oncology and Hematology Clinic Westside ( Site 0179)
Portland, Oregon, 97225
Temple University Hospital ( Site 0133)
Philadelphia, Pennsylvania, 19140
Alliance Cancer Specialists (ACS) ( Site 8010)
Sellersville, Pennsylvania, 18960
Cancer Care Associates Of York ( Site 0174)
York, Pennsylvania, 17403
Medical University of South Carolina ( Site 0153)
Charleston, South Carolina, 29425
Tennessee Cancer Specialists ( Site 7004)
Knoxville, Tennessee, 37909
SCRI Oncology Partners ( Site 7002)
Nashville, Tennessee, 37203
Texas Oncology - West Texas ( Site 8008)
Amarillo, Texas, 79124
Texas Oncology - Central/South Texas ( Site 8006)
Austin, Texas, 78705
Texas Oncology - Northeast Texas ( Site 8002)
Palestine, Texas, 75801
Texas Oncology - San Antonio ( Site 8009)
San Antonio, Texas, 78240
The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0145)
Tyler, Texas, 75701
Intermountain Medical Center ( Site 0182)
Murray, Utah, 84107
Intermountain Healthcare - St. George ( Site 0203)
St. George, Utah, 84790
Virginia Cancer Specialists, PC ( Site 8003)
Manassas, Virginia, 20110
VCU Health Adult Outpatient Pavillion ( Site 0138)
Richmond, Virginia, 23219
Northwest Cancer Specialists (Compass Oncology) ( Site 8000)
Vancouver, Washington, 98684
SSM Health Dean Medical Group ( Site 0106)
Madison, Wisconsin, 53715
Medical College of Wisconsin ( Site 0103)
Milwaukee, Wisconsin, 53226