Patologia: Carcinoma della vescica
Osservazionale-Sperimentale: Sperimentale
Monocentrico-Multicentrico: Multicentrico
Randomizzato: Sì
Fase di studio: II Randomizzato
Richiesta mandatoria di tessuto: Sì
Linee di trattamento: Adiuvante/neoadiuvante
Criteri di inclusione:
- Histologically confirmed muscle-invasive UC (also termed TCC) of the bladder or upper urinary tract
- TNM classification (UICC/AJCC 7th edition) at pathological examination of surgical resection specimen of (y)pT3-4 or (y)pN+ and M0
- Surgical resection of MIUC of the bladder or upper tract
- Participants who have not received prior neoadjuvant cisplatin chemotherapy (NAC) must be ineligible to receive adjuvant cisplatin therapy due to patient refusal, cisplatin ineligibility or investigator decision
- Tumor tissue must be provided for biomarker analysis
- Absence of residual disease and absence of metastasis, as confirmed by a negative baseline Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan of the pelvis, abdomen, and chest no more than 28 days prior to randomization.
- Full recovery from cystectomy or nephroureterectomy within 120 days following surgery
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Negative HIV test at screening
- No evidence of active hepatitis B, defined as having a negative hepatitis B surface antigen (HbsAg) test at screening
- Negative hepatitis C virus (HCV) antibody test at screening, or a positive HCV antibody test followed by a negative HCV RNA test at screening.
Criteri di esclusione:
- Partial cystectomy in the setting of bladder cancer primary tumor or partial nephroureterectomy in the setting of renal pelvis primary tumor
- Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment
- Any prior neoadjuvant immunotherapy
- Adjuvant chemotherapy or radiation therapy for UC following surgical resection
- Malignancies other than UC within 5 years prior to randomization
- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment.
Trattamento sperimentale:
autogene cevumeran
Trattamento di controllo:
nivolumab
AOUI Verona - Borgo Roma
Piazzale Ludovico Antonio Scuro 10 - 37134 Verona - VR
Riferimento: Dr. Andrea Zivi
Telefono: 0458128120
Email: andrea.zivi@aovr.veneto.it
Istituto Nazionale Tumori “Regina Elena”
Via Elio Chianesi 53 - 00144 Roma - RM
Oncologia Medica 1
Telefono: 0652666919
Email: segreteriaom1@ifo.it
A.O. Universitaria Consorziale Policlinico di Bari
Piazza G. Cesare 11 - 70100 Bari - BA
Telefono: 0805593679
Email: oncologiamedica.segreteria@policlinico.ba.it
Numero di iscrizione a registro: 2023-509023-40-00 - NCT06534983
Data di inserimento: 31.10.2024
Hoffmann-La Roche
Riferimento: Dr. Info non disponibile
Telefono: 00000
Email: nd@nd.it
Localita: nd