Autogene Cevumeran: Autogene cevumeran will be administered as an IV infusion per the schedule specified in the arm.
Nivolumab: Nivolumab will be administered as an IV infusion per the schedule specified in the arm.
The original purpose of this study was 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 randomized in either autogene cevumeran + nivolumab or the nivolumab monotherapy arm.
Following the Sponsor's decision to phase out the study, as of Protocol Version 5, the primary purpose of the study is to ensure treatment continuity and safety for the participants who continue to participate in the study and receive study treatment.
| Facility | City | Region | Status |
|---|---|---|---|
| Memorial Sloan Kettering Cancer Center Basking Ridge | Basking Ridge | New Jersey | |
| MSK Monmouth | Middletown | New Jersey | |
| MSK Bergen | Montvale | New Jersey | |
| MSK Commack | Commack | New York | |
| MSK Westchester | Harrison | New York | |
| Memorial Sloan Kettering Cancer Center | New York | New York | |
| MSK Nassau | Uniondale | New York | |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | |
| University of Washington Medical Center | Seattle | Washington | |
| Hospital Italiano | Ciudad Autonoma Buenos Aires | Argentina | |
| Lyell McEwin Hospital | Elizabeth Vale | South Australia | |
| Jewish General Hospital | Montreal | Quebec | |
| McGill University Health Center | Montreal | Quebec | |
| Aalborg Universitetshospital | Aalborg | Denmark | |
| Aarhus Universitetshospital | Aarhus N | Denmark | |
| Herlev Hospital | Herlev | Denmark | |
| Vivantes Klinikum Am Urban | Berlin | Germany | |
| Uniklinikum Heidelberg | Heidelberg | Germany | |
| Marien Hospital Herne | Herne | Germany | |
| Klinikum Stuttgart - Katharinenhospital | Stuttgart | Germany | |
| Attikon University General Hospital | Athens | Greece | |
| Theageneio Hospital | Thessaloniki | Greece | |
| A.O. Universitaria Ospedale Consorziale Policlinico Di Bari | Bari | Apulia | |
| IFO - Istituto Regina Elena | Rome | Lazio | |
| A.O. Universitaria S. Luigi Gonzaga | Orbassano | Piedmont | |
| A.O.U di Verona Policlinico G.B. Rossi | Verona | Veneto | |
| Akershus universitetssykehus | Lørenskog | Norway | |
| Centrum Onkologii im. Prof. Franciszka ?ukaszczyka | Bydgoszcz | Poland | |
| Szpital Kliniczny Ministerstwa Spraw Wewn?trznych i Administracji z Warmi?sko-Mazurskim Centrum Onkologii w Olsztynie | Olsztyn | Poland | |
| AIDPORT Sp. z o. o. | Skórzewo | Poland | |
| Seoul National University Bundang Hospital | Seongnam-si | South Korea | |
| Seoul National University Hospital | Seoul | South Korea | |
| Asan Medical Center | Seoul | South Korea | |
| Samsung Medical Center | Seoul | South Korea | |
| ICO L'Hospitalet | L'Hospitalet de Llobregat | Barcelona | |
| Vall d'Hebron Institute of Oncology (VHIO), Barcelona | Sant Andreu de la Barca | Barcelona | |
| Hospital Clinico San Carlos | Madrid | Spain | |
| Hospital Universitario Virgen del Rocio | Seville | Spain | |
| Hospital Clinico Universitario Lozano Blesa | Zaragoza | Spain | |
| Sahlgrenska University Hospital | Gothenburg | Sweden |
+ 3 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06534983 on ClinicalTrials.gov ↗ ← All trials in the UK