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Evaluating a new treatment for high-risk muscle-invasive bladder cancer

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

Phase 2 Interventional Hoffmann-La Roche · NCT06534983

This study is testing a new treatment that combines two drugs to see if it helps people with high-risk bladder cancer do better than just using one of the drugs alone.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment362 (estimated)
Ages18 Years and up
SexAll
SponsorHoffmann-La Roche Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy, radiation, nivolumab
Locations107 sites (Springdale, Arkansas and 106 other locations)
Trial IDNCT06534983 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effectiveness and safety of combining autogene cevumeran with nivolumab compared to nivolumab alone in patients with high-risk muscle-invasive urothelial carcinoma (MIUC). Initially, participants will undergo a safety run-in phase to monitor the combination treatment's safety. Following this, participants will be randomly assigned to receive either the combination treatment or a control treatment of saline with nivolumab. The study focuses on patients who have undergone surgical resection of their cancer and meet specific eligibility criteria.

Who should consider this trial

Good fit: Ideal candidates include individuals with histologically confirmed muscle-invasive urothelial carcinoma who have undergone surgical resection and meet specific health criteria.

Not a fit: Patients who have received prior neoadjuvant cisplatin chemotherapy or have active metastasis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with high-risk muscle-invasive bladder cancer.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches, suggesting potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion 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 this trial is running

Springdale, Arkansas and 106 other locations

+57 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Muscle-invasive Urothelial Carcinoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.