NCT03558087

Gemcitabine, Cisplatin, Plus Nivolumab in Patients With Muscle-invasive Bladder Cancer With Selective Bladder Sparing

Neoadjuvant Gemcitabine, Cisplatin, Plus Nivolumab in Patients With Muscle-invasive Bladder Cancer With Selective Bladder Sparing

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Matthew Galsky · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab	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).
DRUG	Gemcitabine	Gemcitabine 1000mg/m\^2 will be administered on Days 1 and 8 for four 21-day cycles.
DRUG	Cisplatin	Cisplatin 70mg\^m2 will be administered on Day 1 for four 21-day cycles.

Timeline

• Start date: 2018-07-13
• Primary completion: 2024-02-16
• Completion: 2024-03-07
• First posted: 2018-06-15
• Last updated: 2024-06-27
• Results posted: 2024-06-27

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study