Taking people in FrancePhase 2/3
Compares izalontamab brengitecan with chemotherapy in bladder cancer after immunotherapy
Tests izalontamab brengitecan against chemotherapy in adults with urothelial cancer that spread after immunotherapy.
Key facts
- Who runs it
- Bristol-Myers Squibb
- Where
- Bordeaux, Brest, Clermont-Ferrand, Lyon Cedex08, Marseille, Nice, Paris, Saint-Herblain, Strasbourg, Suresnes, and Villejuif, FranceSee the 12 sitesAlso in 21 other countries, 151 sites
- Trial code
- Registry title
- Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy
- Status
- Recruiting
- Phase
- Phase 2/3
- People taking part
- 470 people, planned
- Started
- 30 Sept 2025
- Expected to end
- 18 Nov 2033
- Type of study
- Interventional, 5 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Iza-bren
- Cisplatin
- Gemcitabine
- Carboplatin
- Record updated
- 29 July 2026
Who can take part
AI summary
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
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in France
Also in 21 other countries, 151 sites
- CHU de Bordeaux Hop St ANDREBordeaux, FranceContact: Marine Gross-Goupil, Site 0004Taking people
- CHRU de BrestBrest, FranceContact: Benjamin Auberger, Site 0258Taking people
- Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'AuvergneClermont-Ferrand, FranceContact: Hakim Mahammedi, Site 0003Taking people
- Centre Leon BerardLyon Cedex08, FranceContact: Aude Flechon, Site 0006Taking people
- Marseille, Provence-Alpes-Côte d'Azur RegionHospital not named in the registryNo longer taking part
- Centre Antoine LacassagneNice, FranceContact: Delphine Borchiellini, Site 0009Taking people
- Groupe hospitalier Paris saint JosephParis, FranceContact: Carole Helissey, Site 0007Taking people
- Hôpital Européen Georges PompidouParis, FranceContact: Constance THIBAULT, Site 0008Taking people
- Institut de Cancérologie de l'OuestSaint-Herblain, FranceContact: Frederic Rolland, Site 0002Taking people
- CHU Strasbourg-HautepierreStrasbourg, FranceContact: Philippe Barthelemy, Site 0040Taking people
- Hopital FochSuresnes, FranceContact: Yann Alexandre VANO, Site 0223Taking people
- Gustave RoussyVillejuif, FranceContact: Yohann Loriot, Site 0001Taking people
About the trial
What the trial wants to find out
A Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy
The 5 groups in the trial
- Arm ATreatment being tested
Treatment: Iza-bren
- Arm BTreatment being tested
Treatment: Iza-bren
- Arm CExisting treatment, for comparison
Treatment: Cisplatin, Gemcitabine, and Carboplatin
- Arm DTreatment being tested
Treatment: Iza-bren
- Arm EExisting treatment, for comparison
Treatment: Cisplatin, Gemcitabine, and Carboplatin
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 doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Compares izalontamab brengitecan with chemotherapy in bladder cancer after immunotherapyGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 29 July 2026