The purpose of this study is to evaluate zilovertamab vedotin with respect to objective response rate and duration of response per Lugano Response Criteria as assessed by blinded independent central review (BICR). Safety and tolerability will also be evaluated in this Phase 2, single arm, interventional study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
IV infusion
Objective Response Rate (ORR) per Lugano Response Criteria
ORR is percentage of participants with complete response (CR) or partial response (PR). ORR by cohort, relapsed or refractory (rr) DLBCL as assessed by BICR according to Lugano Response Criteria 2014 in participants treated with zilovertamab vedotin Q3W. CR is the complete radiologic response. PR is a partial response, \>=50% decrease in sum of the product of the perpendicular diameters for multiple lesions for up to 6 target measurable nodes and extranodal sites.
Time frame: Up to approximately 50 months
Duration of Response (DOR) per Lugano Response Criteria
Duration of Response (DOR) is time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Time frame: Up to approximately 50 months
Number of Participants Who Experience an Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE will be presented.
Time frame: Up to approximately 50 months
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be presented.
Time frame: Up to approximately 50 months
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St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0229)
Orange, California, United States
Innovative Clinical Research Institute ( Site 0202)
Whittier, California, United States
Georgetown University Medical Center ( Site 0204)
Washington D.C., District of Columbia, United States
Northside Hospital ( Site 0206)
Atlanta, Georgia, United States
University of Chicago Medical Center ( Site 0207)
Chicago, Illinois, United States
Franciscan St. Francis Health ( Site 0225)
Indianapolis, Indiana, United States
University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 0211)
Baltimore, Maryland, United States
Massachusetts General Hospital-Cancer Center Protocol Office ( Site 0203)
Boston, Massachusetts, United States
University of Michigan ( Site 0200)
Ann Arbor, Michigan, United States
Karmanos Cancer Institute ( Site 0216)
Detroit, Michigan, United States
...and 61 more locations