Phase II/III Study of Izalontamab Brengitecan vs. Platinum-Based Chemotherapy in Metastatic Urothelial Carcinoma with Disease Progression During or After Immunotherapy
Résumé de l'étude
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 étudiée
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)
Maladie en cours d'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)
Critères d'exclusion
- 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)
Lieu de l’étude
Chur, St-Gall, 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 pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof. Dr med. Anja Lorch
+ 41 432530250
anja.lorch@clutterusz.chUniversitätsspital Zürich Klinik für Medizinische Onkologie und Hämatologie Rämistrasse 100 8091 Zürich
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
31.10.2025
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
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)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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