Phase II/III Study of Izalontamab Brengitecan vs. Platinum-Based Chemotherapy in Metastatic Urothelial Carcinoma with Disease Progression During or After Immunotherapy
Summary description of the study
The study we are conducting consists of two parts, referred to as Phase 2 and Phase 3. In Phase 2, we aim to find the best dose of IZA-BREN. We will investigate how safe it is, how well it works, and how the body processes it. We will also compare two different dosages of IZA-BREN with a platinum-based chemotherapy (PBC) to determine which is more effective in patients who have already tried other treatments. In Phase 3, we plan another comparison of the IZA-BREN dose selected in Phase 2 with a PBC in a larger population to confirm whether IZA-BREN works better than a PBC in patients who have already tried other treatments. The main objective of the study is to determine the recommended dose of IZA-BREN for Phase 3 of the study (Phase 2) and to evaluate the efficacy endpoints of IZA-BREN compared to PBC (Phase 3). Efficacy endpoints are measurements that examine how well the study treatment works. The study duration for each participant is approximately up to 5 years. During screening, the patient will have at least one visit, and during the treatment phase, at least two visits per treatment cycle. In the follow-up phase, the patient will have 1-2 visits, then a follow-up visit or a phone appointment every 12 weeks.
(BASEC)
Intervention under investigation
In Phase 2 of the study, participants will be divided into three groups:
• Arm A: IZA-BREN (Dose Level 1), or
• Arm B: IZA-BREN (Dose Level 2), or
• Arm C: PBC (Cisplatin/Carboplatin + Gemcitabine for up to 6 cycles)
Once the dose selection for IZA-BREN is completed, participants in Phase 3 will be divided into two groups:
• Arm D: IZA-BREN (RP3D), or
• Arm E: PBC (Cisplatin/Carboplatin + Gemcitabine for up to 6 cycles)
(BASEC)
Disease under investigation
metastatic urothelial carcinoma
(BASEC)
- Participants must have histologically confirmed advanced urothelial carcinoma. - Participants must be eligible for platinum-based chemotherapy. - Participants must have been pre-treated with Anti-PD-(L)1 (programmed cell death ligand 1, a protein on cancer cells that prevents the immune system from attacking cancer) (in the locally advanced or metastatic setting), either in combination with another systemic therapy or subsequently. - Participants who are treated only in the perioperative setting (the period around surgery) must have experienced a recurrence (worsening of the disease) within 12 months after the last dose of treatment. (BASEC)
Exclusion criteria
- Participants must not have received platinum-based chemotherapy within the last 12 months. - Participants must not have received more than 2 previous treatment regimens, regardless of the setting. - Additional inclusion/exclusion criteria as specified in the study protocol apply. (BASEC)
Trial sites
Chur, St. Gallen, Zurich
(BASEC)
Sponsor
Bristol-Myers Squibb Services Unlimited Company Plaza 254 Blanchardstown Corporate Park 2 Ballycoolin Dublin 15 D15 T867 Ireland Sponsorvertreter Schweiz Carmen Lilla Bristol-Myers Squibb SA Hinterbergstrasse 16 6312 Steinhausen Switzerland
(BASEC)
Contact
Contact Person Switzerland
Prof. Dr med. Anja Lorch
+ 41 432530250
anja.lorch@clutterusz.chUniversitätsspital Zürich Klinik für Medizinische Onkologie und Hämatologie Rämistrasse 100 8091 Zürich
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
31.10.2025
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
CA244-0012 - IZABRIGHT-BLADDER01: A RANDOMIZED, OPEN-LABEL, PHASE 2/3 TRIAL OF IZALONTAMABBRENGITECAN VERSUS PLATINUM-BASED CHEMOTHERAPY FOR METASTATIC UROTHELIAL CANCER IN PARTICIPANTS WITH DISEASE PROGRESSSION ON OR AFTER AN IMMUNOTHERAPY-BASED TREATMENT (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
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Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
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Further information on the trial
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Results of the trial
Results summary
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Link to the results in the primary register
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