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NCT04506554 · ClinicalTrials.gov registry record · Phase 2
A Study of Risk Enabled Therapy After Neoadjuvant Immunochemotherapy for Bladder Cancer
A Phase 2 study of Muscle-Invasive Bladder Carcinoma, sponsored by Fox Chase Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 81
- Enrollment target
- 4
- Study locations
NCT04506554: Active Phase 2 study of Muscle-Invasive Bladder Carcinoma, sponsored by Fox Chase Cancer Center.
NCT04506554 is a Phase 2 study of Muscle-Invasive Bladder Carcinoma that is active but no longer recruiting, run by Fox Chase Cancer Center. The registered enrollment target is 81 participants, below the 120-participant average among 14 other Muscle-Invasive Bladder Carcinoma trials with a reported enrollment target (32% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04506554, a Phase 2 study of Muscle-Invasive Bladder Carcinoma, is active but no longer recruiting, sponsored by Fox Chase Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 81 participants
- Enrollment target
- 4
- Study locations
Study Summary
Neoadjuvant accelerated methotrexate/vinblastine/adriamycin/cisplatin (AMVAC) in combination with nivolumab is under evaluation for the treatment of muscle invasive bladder cancer (MIBC). Patients with pre-specified tumor mutations and complete clinical response with neoadjuvant therapy will preserve their bladders and go on active surveillance.
Primary Outcome
MFS is defined as a recurrence of urothelial carcinoma that is \>cN1 (more than one clinically suspicious pelvic lymph node) or surgically unresectable local recurrence (e.g., \>cT4a) or M1 disease.
Conditions Studied
Interventions
- DRUG AMVAC + Nivolumab
Study Locations (4)
Pennsylvania
- Thomas Jefferson University Hospital - Philadelphia
- Fox Chase Cancer Center - Philadelphia - Philadelphia
North Carolina
- UNC Lineberger Comprehensive Cancer Center - Chapel Hill
Texas
- UT Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2020-12-01 |
| Est. Completion | 2028-11 |
| Phase | Phase 2 |
What the registry record for NCT04506554 still lists
NCT04506554 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 120-participant average among 14 other Muscle-Invasive Bladder Carcinoma trials with a reported enrollment target (32% lower).
The record links to 1 condition, with Muscle-Invasive Bladder Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which AMVAC + Nivolumab is the first listed.
NCT04506554 reports a single indexed study location in Pennsylvania, North Carolina, Texas.
Frequently Asked Questions
What is clinical trial NCT04506554 about?
NCT04506554 is a clinical study titled "A Study of Risk Enabled Therapy After Neoadjuvant Immunochemotherapy for Bladder Cancer". Neoadjuvant accelerated methotrexate/vinblastine/adriamycin/cisplatin (AMVAC) in combination with nivolumab is under evaluation for the treatment of muscle invasive bladder cancer (MIBC). Patients with pre-specified tumor mutations and complete clinical response with neoadjuvant therapy will preserv...
What is the current status of trial NCT04506554?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2020-12-01. Estimated completion is 2028-11.
What conditions does trial NCT04506554 study?
This clinical trial studies the following conditions: Muscle-Invasive Bladder Carcinoma.
What interventions are being tested in trial NCT04506554?
The interventions under investigation include: AMVAC + Nivolumab (DRUG).
Who is sponsoring clinical trial NCT04506554?
This trial is sponsored by Fox Chase Cancer Center, which has 183 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04506554 being conducted?
This trial has 4 study locations across North Carolina, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Muscle-Invasive Bladder Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04506554's enrollment target sits among peer trials
81 4th of 14 higher than 11 of 14 other Muscle-Invasive Bladder Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Muscle-Invasive Bladder Carcinoma 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
-
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