Study on the Effectiveness and Safety of Autogene Cevumeran with Nivolumab Compared to Nivolumab Alone in Patients with High-Risk Muscle-Invasive Urothelial Carcinoma

Sponsor: Hoffmann-La Roche

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06534983

Provider View

This clinical trial is testing whether adding a new treatment, autogene cevumeran, to the standard drug nivolumab is more effective than using nivolumab alone for patients with high-risk muscle-invasive urothelial carcinoma (MIUC).

Patient Parameters

Program Overview

The main goal of this study is to see if combining autogene cevumeran with nivolumab works better than nivolumab alone in treating patients with high-risk muscle-invasive urothelial carcinoma (MIUC). Initially, all participants will receive both autogene cevumeran and nivolumab to ensure safety. After this phase, participants will be randomly assigned to receive either the combination of autogene cevumeran and nivolumab or a placebo with nivolumab.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of muscle-invasive urothelial carcinoma (MIUC) of the bladder or upper urinary tract.
  • Cancer classified as stage (y)pT3-4 or (y)pN+ and M0 based on surgical examination.
  • Surgical removal of the bladder or upper urinary tract cancer.
  • Not eligible for cisplatin chemotherapy due to personal choice, medical reasons, or doctor's decision.
  • Must provide tumor tissue for biomarker testing.
  • No remaining cancer or spread, confirmed by a negative CT or MRI scan within 28 days before starting the study.
  • Fully recovered from surgery within 120 days.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Negative HIV test.
  • No active hepatitis B, confirmed by a negative test.
  • Negative hepatitis C test, or if positive, a follow-up test must be negative.

Exclusion Criteria

  • Partial removal of the bladder or kidney in the context of cancer.
  • Any cancer treatment, including chemotherapy or hormone therapy, within 3 weeks before starting the study.
  • Previous immunotherapy before surgery.
  • Chemotherapy or radiation after surgery for urothelial carcinoma.
  • Other cancers within the last 5 years.
  • Received a live vaccine within 4 weeks before starting the study.

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