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)
NCT04876313 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29
Last updated 2022-04-06
Summary
To assess whether nivolumab+nab-paclitaxel combination results in patients with muscle-invasive bladder cancer
Conditions
- Muscle-Invasive Bladder Carcinoma
Interventions
- DRUG
-
Nivolumab + Nab-paclitaxel
4x3 weekly cycles of 360 mg nivolumab + 125 mg/m\^2 nab-paclitaxel IV on days 1 and 8
- DRUG
-
360 mg IV Q3W x 13 cycles
Sponsors & Collaborators
- collaborator INDUSTRY
-
IRCCS San Raffaele
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-27
- Primary Completion
- 2024-12-31
- Completion
- 2025-06-30
Countries
- Italy
Study Locations
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