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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
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.
Moffitt Cancer Center
Tampa, Florida, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Two-year rate of failure-free survival (FFS)
The definition of failure will include loco-regional recurrence, and distant recurrence. The primary endpoint of the FFS will be determined based on disease recurrence date defined as the time between the start date of chemoradiation and the date of first recurrence or non-cancer related death.
Time frame: 2 years
Rate of failure-free survival at two years in subjects with intact bladder (FFSIB).
This will be measured only in subjects who do not have local recurrence requiring radical cystectomy. The endpoint of FFSIB will be determined based on disease recurrence date defined as the time between the start date of chemoradiation and the date of first recurrence or non-cancer related death.
Time frame: 2 years
Rate of failure free survival at two years on nivolumab
The endpoint of the FFS on nivolumab will be determined based on disease recurrence date defined as the time between the start date of nivolumab and the date of first recurrence or non-cancer related death.
Time frame: 2 years
Rate of acute and late grade 2 or higher treatment related Genitourinary, Gastrointestinal, hematologic and immune related adverse events.
Time frame: Patient safety will be evaluated throughout the treatment period and follow up (treatment with Nivolumab is expected to last 1 year for each patient and follow up for 2 years)
Effect of treatment on Quality of Life
Time frame: Quality of life questionnaires done every 3 months while patients are on treatment for 1 year
Cystoscopic Local Control
Evaluate cystoscopic local control at 6 months, 1 year and 2 years post start of chemoradiation after censoring for distant recurrence. The endpoint will be measurement of local recurrence at 6 months, 1 year and 2 years as determined by cystoscopy.
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Time frame: Done at 6 months, 1 year and 2 years
Rate of salvage cystectomy
Evaluate the rate of salvage cystectomy. This will be measured by the endpoint of radical cystectomy for local recurrence during study treatment.
Time frame: During study treatment that is expected to last for 1 year
Rate of distant failure free survival
Evaluate the rate of distant failure free survival at two years in subjects with intact bladder and those who discontinue study to undergo salvage cystectomy. This will be measured in subjects who do and do not have local recurrence requiring radical cystectomy during study treatment. The endpoint FFS will be determined based on disease recurrence date defined as the time between the start date of chemoradiation and the date of first distant recurrence or non-cancer related death.
Time frame: 2 years
Overall Survival
Evaluate overall survival up to 5 years. This will be measured using Kaplan-Meier methodology for up to 5 years from start of chemoradiation
Time frame: 5 years