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NCT06534983 · ClinicalTrials.gov registry record · 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)
A Phase 2 study of Muscle-invasive Urothelial Carcinoma, sponsored by Hoffmann-La Roche.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 362
- Enrollment target
- 20
- Study locations
NCT06534983 is a Phase 2 study of Muscle-invasive Urothelial Carcinoma that is actively recruiting participants, run by Hoffmann-La Roche. The registered enrollment target is 362 participants. The trial reports 20 study locations across 10 states.
The verdict
NCT06534983, a Phase 2 study of Muscle-invasive Urothelial Carcinoma, is actively recruiting participants, sponsored by Hoffmann-La Roche.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 362 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 362 participants |
| Start Date | 2024-12-09 |
| Est. Completion | 2034-01-06 |
| Phase | Phase 2 |
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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, categorized as Phase 2. 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 909 total studies on file at ClinicalTrials.gov.
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.
NCT06534983 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, New York, New Jersey.
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.
What interventions are being tested in trial NCT06534983?
The interventions under investigation include: Nivolumab (DRUG), Autogene Cevumeran (DRUG), Saline (DRUG).
Who is sponsoring clinical trial NCT06534983?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.