BO45230 - Evaluating autogene cevumeran + nivolumab vs saline + nivolumab in urothelial carcinoma

• Research type

  Research Study

• Full 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

• IRAS ID

  1009719

• Contact name

  Deepak Pardhi

• Contact email

  uk.dra@roche.com

• Sponsor organisation

  F. Hoffmann-La Roche Ltd

• Eudract number

  2023-509023-40

• Clinicaltrials.gov Identifier

  NCT06534983

• Research summary

  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 personalised 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.

  In this study, the participant will receive either autogene cevumeran plus nivolumab or saline plus nivolumab. Neither the participant nor the study staff will know which treatment group the participants are in. Study treatment will be given over approximately 21 months.

  Approximately 23 participants will take part in the study in the UK and 362 worldwide.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  24/SC/0166

• Date of REC Opinion

  23 Jul 2024

• REC opinion

  Further Information Favourable Opinion