IZABRIGHT-Bladder01: A Randomized, Open-label, Phase 2/3 Trial of Izalontamab Brengitecan Versus Platinum-based Chemotherapy for Metastatic Urothelial Cancer in Participants With Disease Progression on or After an Immunotherapy-based Treatment
Summary
A Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy
Arms & interventions
- DrugIza-bren
Specified dose on specified days
- DrugCisplatin
Specified dose on specified days
- DrugGemcitabine
Specified dose on specified days
- DrugCarboplatin
Specified dose on specified days
Outcome measures
Primary
Phase 2: Recommended Phase 3 Dose (RP3D) of BMS-986507
Time frame: Approximately 3 months
Phase 3: Progression-Free Survival (PFS)
Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR)
Time frame: Up to 5 years
Phase 3: Overall Survival (OS)
Time frame: Up to 5 years
Secondary
Phase 2: Objective Response (OR)
Time frame: Up to 5 years
Phase 2: PFS
Time frame: Up to 5 years
Phase 2: Duration of Response (DOR)
Time frame: Up to 5 years
Phase 2: Time to Response (TTR)
Time frame: Up to 5 years
Phase 2: OS
Time frame: Up to 5 years
Phase 2: Iza-bren antibody-drug conjugate (ADC) concentration
Time frame: Up to 5 years
Phase 2: Iza-bren total antibody concentration
Time frame: Up to 5 years
Phase 2: Iza-bren Ed-04 payload concentration
Time frame: Up to 5 years
Phase 2: Iza-bren observed concentration at end of infusion (Ceoi)
Time frame: Up to 5 years
Phase 2: Iza-bren trough observed concentration (Ctrough)
Time frame: Up to 5 years
Phase 3: OR
Time frame: Up to 5 years
Phase 3: DoR
Time frame: Up to 5 years
Phase 3: TTR
Time frame: Up to 5 years
Phase 3: Time until definitive deterioration in the EORTC QLQ-C30 Global Health Status/Quality of Life (GHS/QoL) scale
Time frame: Up to 5 years
Eligibility criteria
Study locations (35)
Local Institution - 0167
Gilbert, Arizona, 85234
Local Institution - 0162
Fullerton, California, 92835
Palo Alto Center-Palo Alto Medical Foundation Research Institute
Palo Alto, California, 94304
Sutter Health - Sutter Institute for Medical Research
Sacramento, California, 95816
University of California Davis (UC Davis) Comprehensive Cancer Center
Sacramento, California, 95817
Pacific Hematology Oncology Associates
San Francisco, California, 94115
Sutter Santa Rosa
Santa Rosa, California, 95403
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, 80218
Local Institution - 0245
Dillon, Colorado, 80435
Shaw Cancer Center
Edwards, Colorado, 81632
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
Local Institution - 0247
Miami, Florida, 33176
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Local Institution - 0195
Boston, Massachusetts, 02215
Karmanos Cancer Institute
Detroit, Michigan, 48201
Local Institution - 0248
Buffalo, New York, 14203
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Fairview Hospital
Cleveland, Ohio, 44111
Cleveland Clinic
Cleveland, Ohio, 44195
The James Outpatient Care West Campus
Columbus, Ohio, 43221
Cleveland Clinic - Hillcrest Hospital
Mayfield Heights, Ohio, 44124
Local Institution - 0141
Portland, Oregon, 97239
SCRI Oncology Partners
Nashville, Tennessee, 37203
Local Institution - 0084
Nashville, Tennessee, 37232
Texas Oncology - West Texas
Abilene, Texas, 79606
Local Institution - 0187
Austin, Texas, 78705
Intermountain Medical Center
Murray, Utah, 84107
St George Regional Hospital Cancer Center
St. George, Utah, 84790
University of Virginia Health System
Charlottesville, Virginia, 22903
Local Institution - 0188
Norfolk, Virginia, 23502
Local Institution - 0200
Seattle, Washington, 98101
Local Institution - 0255
Seattle, Washington, 98109
Local Institution - 0259
Seattle, Washington, 98195