Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 2 study of Muscle-invasive Urothelial Carcinoma, sponsored by Hoffmann-La Roche.
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, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (172% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
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 |
What NCT06534983 shows while recruiting
NCT06534983 is an interventional study that assigns participants to a tested intervention. The registered 362 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (172% higher).
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 names 20 study sites across 10 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06534983's enrollment target sits among peer trials
362 122nd of 2000 higher than 1,879 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04988555 · 362 participants · Phase 1
A Study of DSP-5336 in Relapsed/Refractory AML/ ALL With or Without MLL Rearrangement or NPM1 Mutation
- NCT05536141 · 362 participants · Phase 1
A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors
- NCT06472245 · 363 participants · Phase 3
Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor
- NCT05533697 · 361 participants · Phase 1
Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI