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)

Launched by HOFFMANN-LA ROCHE · Jul 30, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness and safety of a new treatment called autogene cevumeran when used alongside nivolumab for patients with high-risk muscle-invasive urothelial carcinoma (a type of bladder cancer). The main goal is to see if this combination works better than nivolumab alone. Initially, participants will be monitored closely in a safety phase to ensure the treatment is safe for them. After this, they will be randomly assigned to receive either the combination treatment or a placebo (a saline solution) plus nivolumab.

To join the study, participants must have a confirmed diagnosis of muscle-invasive urothelial carcinoma, have undergone surgery to remove the cancer, and must not have received certain previous treatments. Participants should be recovering well from surgery and have no signs of active disease based on recent imaging tests. This trial is open to individuals aged 65 and older, regardless of gender. Those who participate will help researchers understand if this new treatment can improve outcomes for patients with this serious condition.

Gender

ALL

Eligibility criteria

• 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