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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 · View on ClinicalTrials.gov ↗

Study Summary

The main purpose of the study is 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 saline + nivolumab arm.

Interventions

  • DRUG Nivolumab
  • DRUG Autogene Cevumeran
  • DRUG Saline

Study Locations (20)

California

  • Kaiser Permanente - Baldwin Park — Baldwin Park
  • City of Hope Cancer Center — Duarte
  • Kaiser Permanente - Los Angeles (N. Vermont) — Los Angeles
  • Kaiser Permanente - Riverside — Riverside
  • University of California San Francisco — San Francisco

New York

  • MSK Commack — Commack
  • MSK Westchester — Harrison
  • Columbia University Irving Medical Center — New York
  • Memorial Sloan Kettering Cancer Center — New York
  • MSK Nassau — Uniondale

New Jersey

  • Memorial Sloan Kettering Cancer Center Basking Ridge — Basking Ridge
  • MSK Monmouth — Middletown
  • MSK Bergen — Montvale

Arkansas

  • Highlands Oncology Group. — Springdale

Connecticut

  • Yale Cancer Center — New Haven

District of Columbia

  • Georgetown University Medical Center Lombardi Cancer Center — Washington D.C.

Kentucky

  • Norton Cancer Institute — Louisville

Michigan

  • Henry Ford Health System — Detroit

Trial Details

FieldValue
Enrollment Target 362 participants
Start Date 2024-12-09
Est. Completion 2034-01-06
Phase Phase 2

Sponsor

Hoffmann-La Roche

758 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06534983

The ClinicalTrials.gov registry entry for NCT06534983 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 362 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Muscle-invasive Urothelial Carcinoma appearing as the primary indexed condition, and to 3 interventions — of which Nivolumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06534983 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, New York, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06534983 about?

NCT06534983 is a clinical study titled "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)". The main purpose of the study is 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 ph...

What is the current status of trial NCT06534983?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 362 participants. The study started on 2024-12-09. Estimated completion is 2034-01-06.

What conditions does trial NCT06534983 study?

This clinical trial studies the following conditions: Muscle-invasive Urothelial Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06534983?

The interventions under investigation include: Nivolumab (DRUG), Autogene Cevumeran (DRUG), Saline (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06534983?

This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06534983 being conducted?

This trial has 20 study locations across Arkansas, California, Connecticut, District of Columbia, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial