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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)
Trial Status: active
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 risk
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 monitor 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.
Inclusion Criteria
Participants must have the capacity to participate/enroll in the study and to provide informed consent
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 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 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) 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 RNA test at screening
Exclusion Criteria
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
Additional locations may be listed on ClinicalTrials.gov for NCT06534983.
