WHO ICTRP trial

Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for…

CTIS2025-522400-24-00 · EU Clinical Trials Information System · Not Recruiting

Key facts

Trial ID CTIS2025-522400-24-00
Public title Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy
Scientific 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 - CA2440012
Primary sponsor Bristol-Myers Squibb Services Unlimited Company
Registry EU Clinical Trials Information System
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): No Therapeutic exploratory (Phase II): Yes Therapeutic confirmatory - (Phase III): Yes Therapeutic use - (Phase IV): No
Countries Argentina;Brazil;Canada;Switzerland;China;Korea, Republic of;United States;United Kingdom;Australia;Japan;Israel;Austria;Belgium;France;Germany;Ireland;Italy;Romania;Spain;Sweden;Norway
Conditions Metastatic urothelial cancer MedDRA version: 27.0Level: LLTClassification code: 10090000Term: Urothelial carcinoma metastatic Class: 100000004864;Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications…
Interventions Product Name: PEGFILGRASTIM, Product Code:SUB16451MIG, Pharmaceutical Form: SOLUTION FOR INJECTION, Other descriptive name: , Strength: , Product Name: CARBOPLATIN, Product Code:SUB06614MIG, Pharmaceutical Form: CONCENTRATE FOR SOLUTION FOR…
Registration date Aug 29, 2025
Target size 452
Secondary IDs U1111-1322-9071
Registry page euclinicaltrials.eu

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