Trials / Active Not Recruiting
Active Not RecruitingNCT03171025
Adjuvant Nivolumab Following Chemo-Radiation in Localized Muscle-Invasive Bladder Cancer
A Phase II Open Label Single Arm Study of Adjuvant Nivolumab Following Chemo-Radiation in Localized Muscle-Invasive Bladder Cancer (NEXT)
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (actual)
- Sponsor
- University of Utah · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase 2, single arm, open label trial to evaluate the rate of failure free survival at 2 years after start of chemoradiation with adjuvant nivolumab in adult subjects who undergo chemoradiation for localized bladder cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nivolumab | Nivolumab at a dose of 480 mg will be administered as an IV infusion over 60 minutes every 4 weeks until disease recurrence or discontinuation due to unacceptable toxicity for a maximum of 12 treatments over an expected duration of 1 year. |
Timeline
- Start date
- 2017-07-10
- Primary completion
- 2025-02-10
- Completion
- 2027-10-31
- First posted
- 2017-05-31
- Last updated
- 2026-01-07
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03171025. Inclusion in this directory is not an endorsement.