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
- Innsbruck and Vienna, AustriaSee the 3 sites
- Phase
- Phase 2/3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or metastatic urothelial cancer (a cancer of the urinary tract lining) whose disease got worse during or after immunotherapy. It compares izalontamab brengitecan with platinum-based chemotherapy.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Advanced urothelial carcinoma confirmed under the microscope, with at least 1 measurable lesion per RECIST v1.1. Daily activity level (ECOG) of 0-1.
- Earlier treatment
- Must have had anti-PD-(L)1 immunotherapy, alone or with another treatment. If treated only around surgery, the cancer must have come back within 12 months of the last dose. Must be able to receive platinum-based chemotherapy. Must not have had platinum chemotherapy within 12 months or more than 2 prior regimens.
Main reasons for not taking part
- Platinum-based chemotherapy within the last 12 months
- More than 2 prior treatment regimens
- Earlier ADC therapy aimed at EGFR or HER3
- Earlier therapy with a topoisomerase 1 inhibitor
- Active brain metastases that have not been treated
Read by machine on 9 November 2026.
Where in Austria
- Medizinische Universitaet InnsbruckInnsbruck, AustriaTaking people
- Klinik OttakringVienna, AustriaTaking people
- Medizinische Universität WienVienna, AustriaTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.