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)

Sponsor
IRCCS San Raffaele
Study ID
NCT04876313
Phase
PHASE2
Status
Unknown

Conditions

  • Muscle-Invasive Bladder Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

To assess whether nivolumab+nab-paclitaxel combination results in patients with muscle-invasive bladder cancer

Key Dates

Start date
Jan 27, 2022
Status verified
Mar 2022
Primary completion
Dec 31, 2024
Completion
Jun 30, 2025

Study Design

Enrollment
29 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combined Drugs
    Participants received 4x3 weekly cycles of 360 mg Nivolumab + 125 mg/m\^2 Nab-paclitaxel IV on days 1 and 8, then they had cystectomy after that partecipants received adjuvant nivolumab 360 mg IV Q3W X13 cycles

Primary Outcome Measure

Pathological complete response [ Time Frame: Change from Screening after radical cystectomy ]

Central Contacts

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