Last updated 28 days ago
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
4Research 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
- 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.
- 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.
Sites
Hospital Británico de Buenos Aires - CABA
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Recruiting
Hospital Civil de Guadalajara Fray Antonio Alcalde
StudyIMCODE004
SponsorHoffmann-La Roche
Study typeInterventional
Conditions
High Risk Muscle Invasive Bladder Cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06534983
