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: Sì

Fase di studio: II Randomizzato

Richiesta mandatoria di tessuto: Sì

Linee di trattamento: Adiuvante/neoadiuvante

Criteri di inclusione: 

- Participants must have the capacity to participate/enroll in the study and to provide informed consent
- Histologically confirmed muscle-invasive UC (also termed transitional cell carcinoma [TCC]) of the bladder or upper urinary tract
- Tumor-node-metastasis (TNM ) classification (Union for International Cancer Control [UICC]/American Joint Committee on Cancer [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 received neoadjuvant chemotherapy (NAC), including antibody drug-conjugate, either alone or in combination with a checkpoint inhibitor (CPI), are eligible
- Participants who have not received any prior NAC are also eligible, provided they meet one of the following criteria, which would make them ineligible to receive adjuvant cisplatin-based therapy: participant 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 human immunodeficiency virus (HIV) test at screening
- Negative hepatitis B surface antigen (HbsAg) test at screening
- Positive hepatitis B surface antibody (HBsAb), or a negative HBsAb at screening accompanied by either of the following: negative total hepatitis B core antibody (HBcAb) or positive total HBcAb test followed by quantitative hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < 500 international units/milliliter (IU/mL)
- Negative hepatitis C virus (HCV) antibody test at screening, or a positive HCV antibody test followed by a negative HCV ribonucleic acid (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
- Adjuvant chemotherapy, immunotherapy, or radiation therapy for UC following surgical resection
- Prior active malignancies within 3 years prior to randomization
- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment.

Trattamento sperimentale: 

Autogene Cevumeran + Nivolumab

Trattamento di controllo: 

Nivolumab

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

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

Data di inserimento: 31.10.2024

Data di aggiornamento: 17.07.2026

Promotore

Hoffmann-La Roche

Principal Investigator ITALIA

Riferimento: Dr. - -

Telefono: 00000

Email: nd@nd.it

Localita: -