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Trial Information

Status:

Open

Specialty:

Bladder

Date Opened:

12/02/2025

Planned Close date:

30/09/2027

Sponsors:

F. Hoffman-La Roche Ltd.

Site Recruitment:

0 /

4

Principal Investigator:

Dr Alison Birtle

Study Title:

IMCODE004

Contacts

Research Nurse / Study Coordinator:

Amanda Cook

Administrator:

Yecora Lecanda-Swarbrick

A RANDOMIZED PHASE II, DOUBLE-BLIND, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF AUTOGENE CEVUMERAN PLUS NIVOLUMAB VERSUS PLACEBO PLUS NIVOLUMAB AS ADJUVANT THERAPY IN PATIENTS WITH HIGH-RISK MUSCLE-INVASIVE UROTHELIAL CARCINOMA

The purpose of this study is to compare the effects, good or bad, of Autogene Cevumeran plus Nivolumab versus Nivolumab on patients with Muscle Invasive Urethral Carcinoma (MIUC). Autogene Cevumeran is a personalized drug product that will be made specifically for each participant and is designed to activate and train the immune system to find and kill cancer cells.

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