Compares izalontamab brengitecan with chemotherapy in bladder cancer after immunotherapy
Tests izalontamab brengitecan against chemotherapy in adults with urothelial cancer that spread after immunotherapy.
Plain-language title generated from the registry record
Registry title: Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy
Key facts
- Where
- Abilene, Austin, Baltimore, Boston, Buffalo, Charlottesville, Cleveland, Columbus, Denver, Detroit, Dillon, Edwards, Fullerton, Gilbert, Lexington, Mayfield Heights, Miami, Murray, Nashville, New York, Norfolk, Palo Alto, Portland, Sacramento, San Francisco, Santa Rosa, Seattle, St. George, and Washington D.C., United StatesSee the 35 sites
- Phase
- Phase 2/3
Where in United States
- Texas Oncology - West TexasAbilene, United StatesTaking people
- AustinAustin, United StatesNot yet recruiting
- Johns Hopkins HospitalBaltimore, United StatesTaking people
- BostonBoston, United StatesNot yet recruiting
- BuffaloBuffalo, United StatesNo longer taking part
- University of Virginia Health SystemCharlottesville, United StatesTaking people
- Cleveland ClinicCleveland, United StatesTaking people
- Fairview HospitalCleveland, United StatesTaking people
- The James Outpatient Care West CampusColumbus, United StatesTaking people
- Rocky Mountain Cancer Centers, LLPDenver, United StatesTaking people
- Karmanos Cancer InstituteDetroit, United StatesTaking people
- DillonDillon, United StatesNo longer taking part
- Shaw Cancer CenterEdwards, United StatesTaking people
- FullertonFullerton, United StatesNot yet recruiting
- GilbertGilbert, United StatesNot yet recruiting
- University of Kentucky Chandler Medical CenterLexington, United StatesTaking people
- Cleveland Clinic - Hillcrest HospitalMayfield Heights, United StatesTaking people
- Miami Cancer Institute at Baptist Health, Inc.Miami, United StatesTaking people
- Intermountain Medical CenterMurray, United StatesTaking people
- NashvilleNashville, United StatesNot yet recruiting
- SCRI Oncology PartnersNashville, United StatesTaking people
- Icahn School of Medicine at Mount SinaiNew York, United StatesTaking people
- Memorial Sloan-Kettering Cancer CenterNew York, United StatesTaking people
- NorfolkNorfolk, United StatesNot yet recruiting
- Palo Alto Center-Palo Alto Medical Foundation Research InstitutePalo Alto, United StatesTaking people
- PortlandPortland, United StatesNot yet recruiting
- Sutter Health - Sutter Institute for Medical ResearchSacramento, United StatesTaking people
- University of California Davis (UC Davis) Comprehensive Cancer CenterSacramento, United StatesTaking people
- Pacific Hematology Oncology AssociatesSan Francisco, United StatesTaking people
- Sutter Santa RosaSanta Rosa, United StatesTaking people
- SeattleSeattle, United StatesNot yet recruiting
- Fred Hutchinson Cancer CenterSeattle, United StatesTaking people
- University of Washington Medical Center - MontlakeSeattle, United StatesTaking people
- St George Regional Hospital Cancer CenterSt. George, United StatesTaking people
- Sibley Memorial HospitalWashington D.C., United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT07106762
- Record updated
- 29 July 2026
- Original description
A Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After ImmunotherapyRead full original descriptionShow less
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
A Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy
Inclusion: Participants must have histologically confirmed advanced urothelial carcinoma; Participants must be eligible to receive platinum-based chemotherapy; Participants must be Anti-PD-(L)1-experienced (in locally advanced or metastatic setting), either in combination with or sequential to another systemic therapy; Participants treated only in the peri-operative setting must have relapsed within 12 months of the last dose of the treatment; Participants must have ≥ 1 measurable lesion per RECIST v1.1; Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
Exclusion: Participants must not have platinum-based chemotherapy exposure within 12 months; Participants must not have received >2 prior regimens irrespective of the setting; Participants must not have prior therapy with topoisomerase 1 inhibitor; Participants must not have prior ADC therapy targeting EGFR or HER3; Participants must not have active, untreated brain metastases; Other protocol-defined inclusion/exclusion criteria apply.