A Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
470
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
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
Phase 2: Objective Response (OR)
Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator
Time frame: Up to 5 years
Phase 2: PFS
Assessed using RECIST v1.1 by investigator
Time frame: Up to 5 years
Phase 2: Duration of Response (DOR)
Assessed using RECIST v1.1 by investigator
Time frame: Up to 5 years
Phase 2: Time to Response (TTR)
Assessed using RECIST v1.1 by investigator
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
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Specified dose on specified days
Local Institution - 0167
Gilbert, Arizona, United States
NOT_YET_RECRUITINGLocal Institution - 0162
Fullerton, California, United States
NOT_YET_RECRUITINGLocal Institution - 0252
Palo Alto, California, United States
NOT_YET_RECRUITINGLocal Institution - 0163
Sacramento, California, United States
NOT_YET_RECRUITINGUniversity of California Davis (UC Davis) Comprehensive Cancer Center
Sacramento, California, United States
RECRUITINGLocal Institution - 0251
San Francisco, California, United States
NOT_YET_RECRUITINGLocal Institution - 0254
Santa Rosa, California, United States
NOT_YET_RECRUITINGLocal Institution - 0245
Dillon, Colorado, United States
WITHDRAWNShaw Cancer Center
Edwards, Colorado, United States
RECRUITINGSibley Memorial Hospital
Washington D.C., District of Columbia, United States
RECRUITING...and 150 more locations
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
As per RECIST v1.1 by BICR
Time frame: Up to 5 years
Phase 3: DoR
As per RECIST v1.1 by BICR
Time frame: Up to 5 years
Phase 3: TTR
As per RECIST v1.1 by BICR
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