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A Study of Autogene Cevumeran with Nivolumab for High-risk Muscle-invasive Urothelial Carcinoma

This study is looking at a new treatment approach for high-risk muscle-invasive urothelial carcinoma (MIUC), a type of bladder or urinary tract cancer. It compares two treatments: autogene cevumeran combined with nivolumab, versus nivolumab alone. Nivolumab is a checkpoint inhibitor, which helps your immune system fight cancer. The study will first enroll a small group to make sure the combined treatment is safe. After that, more participants will be randomly assigned to receive either the combination treatment or nivolumab by itself. The main goal is to track any side effects (adverse events) for about 15 months. You may be able to join if you are 18 or older and have this specific type of cancer.

Study design
This interventional study plans to enroll 62 participants. It includes a safety run-in phase where all participants receive autogene cevumeran + nivolumab, followed by a randomized phase comparing autogene cevumeran + nivolumab to nivolumab alone.
What's involved
Autogene cevumeran and nivolumab will be given as IV infusions according to a specific schedule.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events for up to approximately 15 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06534983

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)

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
Hoffmann-La Roche
~62 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:Autogene CevumeranNivolumab

At a glance

Recruiting sites
0 of 43 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants With Adverse Events (AEs)
Measured over Up to approximately 15 months

Conditions

Muscle-invasive Urothelial Carcinoma

Explore related trials

Urothelial Carcinoma

Where it's being run

43 sites across 21 states
New York4
Germany4
South Korea4
New Jersey3
Denmark3
Poland3
Spain3
Washington2

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of Participants With Adverse Events (AEs)Up to approximately 15 months