A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran With Nivolumab Versus Nivolumab Alone in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (MIUC)
362 patients around the world
Available in Argentina
Hoffmann-La Roche
3Research sites
362Patients around the world
This study is for people with
Bladder Cancer
High Risk Muscle Invasive Bladder Cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
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.
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.
Sites
Hospital Británico de Buenos Aires - CABA
Recruiting
Perdriel 74, CABA, Buenos Aires
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Av. Crámer 1180, CABA, Buenos Aires
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Recruiting
Juan Domingo Perón 4190, Piso 1, Ciudad Autónoma de Buenos Aires, C1181ACH