Phase II/III Study of Izalontamab Brengitecan vs. Platinum-Based Chemotherapy in Metastatic Urothelial Carcinoma with Disease Progression During or After Immunotherapy
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
- 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)
Studienstandort
Chur, St Gallen, Zürich
(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)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Dr med. Anja Lorch
+ 41 432530250
anja.lorch@clutterusz.chUniversitätsspital Zürich Klinik für Medizinische Onkologie und Hämatologie Rämistrasse 100 8091 Zürich
(BASEC)
Wissenschaftliche Auskünfte
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Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
31.10.2025
(BASEC)
ICTRP Studien-ID
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Offizieller Titel (Genehmigt von der Ethikkommission)
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)
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Untersuchte Krankheit(en)
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Untersuchte Intervention
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Ergebnisse der Studie
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