NCT 06534983
Brief Summary
The main purpose of the study is to evaluate the efficacy of adjuvant treatment with autogene cevumeran plus nivolumab compared with nivolumab in participants with high riskthe possibility that something bad will happen MIUC.
In this study participants will be enrolled in a safety run-in phase to receive autogene cevumeran + nivolumab. This phase will be conducted to monitorto check on, keep track of and ensure the safety of study participants. After all participants in the safety run-in have been enrolled to receive autogene cevumeran + nivolumab, further participants will be randomization in either autogene cevumeran + nivolumab or the saline + nivolumab arm.
Intervention / Treatment
- Drug: Autogene Cevumeran
- Drug: Nivolumab
- Drug: Saline
Inclusion Criteria:
- Histologically confirmed muscle-invasive UC (also termed TCC) of the bladdera hollow, muscular sac in the pelvis that stores urine or upper urinary tract
- TNM classification (UICC/AJCC 7th edition) at pathological examination of surgical resectionsurgical removal of tissue or part/all of an organ specimena sample for investigating (e.g. blood, stools, urine, sputum etc.) 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 chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells (NAC) must be ineligible to receive adjuvant cisplatin therapy due to patient refusal, cisplatin ineligibility or investigator decision
- Tumor tissuea group of cells that work together to perform a function must be provided for biomarker analysis
- Absence of residual disease and absence of metastasiswhen the cancer has spread to other parts of the body, also known as mets, as confirmed by a negative baseline Computed Tomography (CT) or Magnetic Resonance Imagingtests that create detailed images of areas inside the body (MRI) scan of the pelvis, abdomenstomach, stomach area, belly, and chest no more than 28 days prior to randomization.
- Full recovery from cystectomycomplete or partial removal of the bladder or nephroureterectomycomplete removal of affected kidney and ureter within 120 days following surgerytreatment involving removal of cancerous tissue and/or tumours and a margin of healthy tissue around it to reduce recurrence
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of 0 or 1
- Negative HIV test at screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer 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) antibodya protein made by the immune system to fight against harmful substances (antigens), such as bacteria or viruses test at screening, or a positive HCV antibody test followed by a negative HCV RNA test at screening