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ACTIVE NOT RECRUITINGPhase2

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)

Sponsor: Hoffmann-La Roche

NCT ID: NCT06534983

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Autogene Cevumeran (drug), Nivolumab (drug)
How long the study runs
Study runs about 35 months (dates as stated)
About the drug or intervention
Autogene Cevumeran — drug: Autogene cevumeran will be administered as an IV infusion per the schedule specified in the arm. · Nivolumab — drug: Nivolumab will be administered as an IV infusion per the schedule specified in the arm.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
62
Started
2024-12-09
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for muscle-invasive urothelial carcinoma
  • • Phase2 - 62 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with muscle-invasive urothelial carcinoma

Where?

  • • Exeter - Royal Devon and Exeter Hospital
  • • London - Barts & London School of Med;Medical Oncology

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Muscle-invasive Urothelial Carcinoma

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

by a negativeor a negativeor positiveor a positive

Treatment history

Treatments you must have had:

  • ✓ the capacity to participate/enroll in the study and to provide informed consent

What the study is looking for

  • ✓Participants must have the capacity to participate/enroll in the study and to provide agreement to take part
  • ✓confirmed by a biopsy muscle-invasive UC (also termed transitional cell carcinoma \[TCC\]) of the bladder or...
  • ✓Surgical resection of MIUC of the bladder or upper tract
  • ✓Participants who have received before surgery drug treatment (NAC), including antibody drug-conjugate, either alone or in...
  • ✓Tumor tissue must be provided for test result analysis

Who cannot take part

  • ✗Partial cystectomy in the setting of bladder cancer primary tumor or partial nephroureterectomy in the setting of...
  • ✗Any approved anti-cancer therapy, including drug treatment, or hormonal therapy within 3 weeks prior to initiation of...
  • ✗after surgery drug treatment, treatment that helps your immune system fight cancer, or radiotherapy 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
See the full criteria
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

Where Is This Study? (2 UK sites)

Royal Devon and Exeter Hospital

Exeter EX2 5DW, United Kingdom

Hospital R&D contact (matched)

Samantha Smart

rduh.research-eastern@nhs.net01392 406075

Barts & London School of Med;Medical Oncology

London EC1M 6BQ, United Kingdom

Hospital R&D contact (matched)

Dr Mays Jawad

research.governance@qmul.ac.uk020 7882 6826
Data sourced from ClinicalTrials.gov · Last verified: 2026-08