At a glance
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Neoadjuvant Gemcitabine, Cisplatin, Plus Nivolumab in Patients With Muscle-invasive Bladder Cancer With Selective Bladder Sparing
In Brief
A Phase 2 clinical trial evaluating Nivolumab, Gemcitabine, and 1 other intervention for Bladder Cancer. Completed, enrolled 76 participants across 7 sites.
Detailed Summary
This is a phase 2 trial seeking to define the safety and activity of gemcitabine, cisplatin, plus nivolumab as neoadjuvant therapy in patients with muscle-invasive bladder cancer and to define the role of clinical complete response in predicting benefit in patients opting to avoid cystectomy.
Study Details
Timeline
Interventions
Nivolumab 360mg will be administered on Day 1 of each 21 day cycle for four 21-day cycles. Based on response and a balanced patient-physician discussion, subjects may receive nivolumab 240 mg for 8 cycles (cycle = 14 days).
Gemcitabine 1000mg/m\^2 will be administered on Days 1 and 8 for four 21-day cycles.
Cisplatin 70mg\^m2 will be administered on Day 1 for four 21-day cycles.