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Clinical Trials in the USA / NCT06534983
Active, not recruiting Phase 2

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)

NCT06534983 · tracked via the Priya Life Science USA tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 2
Started
2024-12-09
Last updated
2026-08-06

Condition(s) studied

Muscle-invasive Urothelial Carcinoma

Investigational drug(s) / intervention(s)

Autogene CevumeranNivolumab

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Participants must have the capacity to participate/enroll in the study and to provide informed consent * Histologically confirmed muscle-invasive UC (also termed transitional cell carcinoma \[TCC\]) of the bladder or upper urinary tract * Tumor-node-metastasis (TNM ) classification (Union for International Cancer Control \[UICC\]/American Joint Committee on Cancer \[AJCC\] 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 received neoadjuvant chemotherapy (NAC), including antibody drug-conjugate, either alone or in combination with a checkpoint inhibitor (CPI), are eligible * Participants who have not received any prior NAC are also eligible, provided they meet one of the following criteria, which would make them ineligible to receive adjuvant cisplatin-based therapy: participant 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 human immunodeficiency virus (HIV) test at screening * Negative hepatitis B surface antigen (HbsAg) test at screening * Positive hepatitis B surface antibody (HBsAb), or a negative HBsAb at screening accompanied by either of the following: negative total hepatitis B core antibody (HBcAb) or positive total HBcAb test followed by quantitative hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< 500 international units/milliliter (IU/mL) * Negative hepatitis C virus (HCV) antibody test at screening, or a positive HCV antibody test followed by a negative HCV ribonucleic acid (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 * Adjuvant chemotherapy, immunotherapy, or radiation therapy for UC following surgical resection * Prior active malignancies within 3 years prior to randomization * Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment

Primary outcome measure(s)

Trial sites (43)

FacilityCityRegionStatus
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.

On this site

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More Hoffmann-La Roche trials in the USA

Official registry record

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 USA