Adjuvant Nivolumab Following Chemo-Radiation in Localized Muscle-Invasive Bladder Cancer

Part of paid clinical trials in Tampa, Florida.

Sponsor
University of Utah
Study ID
NCT03171025
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jul 10, 2017
Status verified
Jan 2026
Primary completion
Feb 10, 2025
Completion
Oct 31, 2027

Study Design

Enrollment
200 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab, all patients

Primary Outcome Measure

Two-year rate of failure-free survival (FFS) [ Time Frame: 2 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612-
Huntsman Cancer InstituteSalt Lake CityUtah84112-

Find similar trials in Tampa, FL

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Moffitt Cancer Center· Tampa, FLHuntsman Cancer Institute· Salt Lake City, UT

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