Clinical Trial

A Study of Risk Enabled Therapy After Neoadjuvant Immunochemotherapy for Bladder Cancer

Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Record status
This record was last updated July 4, 2025 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2020-08-07; most recent amendment 2025-07-02.
Status change: Suspended → Active, Not Recruiting 2024-06-03
Status change: Recruiting → Suspended 2023-12-12
Status change: Not Yet Recruiting → Recruiting 2021-03-15
Trial Details
NCT Number NCT04506554
Lead Sponsor Fox Chase Cancer Center
Conditions Muscle-Invasive Bladder Carcinoma
Enrollment 81 participants
Start Date 2020-12-01
Primary Completion 2026-05 (estimated)
Study Completion 2028-11 (estimated)
Updated on ClinicalTrials.gov 2025-07-04