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BO45230 - A Randomized Phase II, Double-Blind, Multicenter Study Evaluating the Efficacy and Safety of Autogene Cevumeran Plus Nivolumab Versus Nivolumab as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Urothelial Carcinoma (IMCODE004)

Studio Clinico

Patologia: Carcinoma della vescica

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: II Randomizzato

Richiesta mandatoria di tessuto: 

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

Centri partecipanti

Nord Italia

AOUI Verona - Borgo Roma
Piazzale Ludovico Antonio Scuro 10 - 37134 Verona - VR

Riferimento: Dr. Andrea Zivi
Telefono: 0458128120
Email: andrea.zivi@aovr.veneto.it

 

Centro Italia

Istituto Nazionale Tumori “Regina Elena”
Via Elio Chianesi 53 - 00144 Roma - RM
Oncologia Medica 1

Telefono: 0652666919
Email: segreteriaom1@ifo.it

 

Sud Italia e isole

A.O. Universitaria Consorziale Policlinico di Bari
Piazza G. Cesare 11 - 70100 Bari - BA

Telefono: 0805593679
Email: oncologiamedica.segreteria@policlinico.ba.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2023-509023-40-00 - NCT06534983

Data di inserimento: 31.10.2024

Promotore

Hoffmann-La Roche

Principal Investigator ITALIA

Riferimento: Dr. Info non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: nd

 

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