Interventional Recruiting Phase 2
NCT04876313 on ClinicalTrials.gov
An Open Label, Single-arm, Phase 2 Study of Neoadjuvant Nivolumab and Nab-paclitaxel Before Radical Cystectomy for Patients With Muscle-invasive Bladder Cancer (NURE-Combo)
Official title: An Open Label, Single-arm, Phase 2 Study of Neoadjuvant Nivolumab and Nab-paclitaxel Before Radical Cystectomy for Patients With Muscle-invasive Bladder Cancer
- Sponsor: IRCCS Ospedale San Raffaele
- Collaborators: Bristol-Myers Squibb
- Enrollment: 29 (Estimated)
- Study start: 2022-01-27 (Actual)
- Primary completion: 2024-12-01 (Estimated)
- Study completion: 2025-06-01 (Estimated)
- Allocation: N/a
- InterventionModel: Single Group
- InterventionModelDescription: Patients with muscle-invasive urothelial bladder carcinoma, not eligible or denying standard neoadjuvant therapy
- Masking: None
- PrimaryPurpose: Treatment
Brief Summary
To assess whether nivolumab+nab-paclitaxel combination results in patients with muscle-invasive bladder cancer
Conditions
- Muscle-Invasive Bladder Carcinoma
Intervention / Treatment
- Drug: Nivolumab + Nab-paclitaxel
- Drug: Nivolumab
Primary Outcome Measures
-
Pathological complete response
(Change from Screening after radical cystectomy)
To assess whether nab-paclitaxel plus nivolumab results in pathological complete response (herein referred to as either "ypT0N0M0" or "pCR") in patients with clinical T2-4aN0M0 MIBC who cannot receive or refuse to receive cisplatin-based chemotherapy. Absence of any residual viable tumor in the radical cystectomy specimen. Two independent pathologists, blinded to the study findings, with \>10 years of experience in genitourinary tumors will independently evaluate the response.
Countries
Italy
Locations and Investigators
-
Genitourinary Medical Oncology - IRCCS San Raffaele Hospital and Scientific Institute, Milan, Italy (Recruiting)
- Andrea Necchi
- Rossella Miotti
- Andrea Necchi (Principal Investigator)