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)

  • Cancer
  • Bladder Cancer
  • Muscle Invasive Urothelial Carcinoma
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Recruiting

This study runs in
Countries
  • Argentina
  • Australia
  • Belgium
  • Canada
  • Denmark
  • France
  • Germany
  • Greece
  • Italy
  • Korea, Republic of
  • Mexico
  • Netherlands
  • Norway
  • Poland
  • Spain
  • Sweden
  • Taiwan
  • United Kingdom
  • United States
Study Identifier:

NCT06534983 BO45230

      Show study locations

      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Study 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 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.

      Hoffmann-La Roche Sponsor
      Phase 2 Phase
      NCT06534983, BO45230 Study Identifier
      Autogene Cevumeran, Nivolumab, Saline Treatments
      Muscle Invasive Urothelial Carcinoma Condition
      Official Title

      A Randomized Phase II, Double-Blind, Multicenter Study Evaluating the Efficacy and Safety of Autogene Cevumeran Plus Nivolumab Versus Nivolumab as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Urothelial Carcinoma

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • 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
      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

      For the latest version of this information please go to www.forpatients.roche.com

       

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