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
Bristol-Myers Squibb
Summary
A Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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) Per…
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
Locations (163)
- Local Institution - 0167Gilbert, Arizona
- Local Institution - 0162Fullerton, California
- Palo Alto Center-Palo Alto Medical Foundation Research InstitutePalo Alto, California
- Sutter Health - Sutter Institute for Medical ResearchSacramento, California
- University of California Davis (UC Davis) Comprehensive Cancer CenterSacramento, California
- Pacific Hematology Oncology AssociatesSan Francisco, California