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
- Berlin, Düsseldorf, Frankfurt, Hamburg, Hanover, Heidelberg, Herne, Jena, Kiel, Munich, Nuremberg, Nürtingen, Regensburg, and Ulm, GermanySee the 14 sites
- Phase
- Phase 2/3
Where in Germany
- Charité - Universitaetsmedizin Berlin - Campus Bejnamin FranklinBerlin, GermanyTaking people
- Universitaetsklinikum DuesseldorfDüsseldorf, GermanyTaking people
- Krankenhaus Nordwest GmbHFrankfurt, GermanyTaking people
- Universitaetsklinikum Hamburg-EppendorfHamburg, GermanyTaking people
- Medizinische Hochschule HannoverHanover, GermanyTaking people
- NCTHeidelberg, GermanyTaking people
- Marienhospital HerneHerne, GermanyTaking people
- Universitätsklinikum JenaJena, GermanyTaking people
- Universitaetsklinikum Schleswig Holstein Campus KielKiel, GermanyTaking people
- TUM KlinikumMunich, GermanyTaking people
- Klinikum Nürnberg NordNuremberg, GermanyTaking people
- Studienpraxis UrologieNürtingen, GermanyTaking people
- Caritas-Krankenhaus St. JosefRegensburg, GermanyTaking people
- Universitaetsklinikum UlmUlm, GermanyTaking 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.