This Phase III, open-label, randomized, multicenter study is to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with observation in participants with muscle-invasive UC who are at high risk for recurrence following resection. Eligible participants were randomized by a 1:1 ratio into atezolizumab group or control group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
809
Atezolizumab will be administered at a dose of 1200 milligrams (mg).
Disease-Free Survival (DFS), as Assessed by Investigator
DFS is defined as the time from randomization to the time of first occurrence of a DFS event. DFS events include: local (pelvic) recurrence of UC (including soft tissue and regional lymph nodes); urinary tract recurrence of UC (including all pathological stages and grades); distant metastasis of UC; or death from any cause. Tumor assessment will be performed using radiographic evaluations.
Time frame: Randomization up to first occurrence of DFS event (up to approximately 50 months)
Overall Survival (OS)
Overall survival is defined as the time from randomization to the date of death from any cause, regardless of whether the death occurs during study treatment or following treatment discontinuation.
Time frame: Randomization until death due to any cause (up to approximately 80 months)
Disease-Specific Survival (DSS), as Assessed by Investigator
DSS is defined as the time from randomization until the date of death from UC.
Time frame: Randomization until death due to UC (up to approximately 50 months)
Distant Metastasis-Free Survival (DMFS)
DMFS is defined as the time from randomization to the date of diagnosis of distant (that is, non-locoregional) metastases or death from any cause. Tumor assessment will be performed using radiographic evaluations.
Time frame: Randomization up to diagnosis of distant metastases or death from any cause (up to approximately 50 months)
Non-Urinary Tract Recurrence-Free Survival (NURFS)
NURFS is defined as the time from randomization to the time of first occurrence of a NURFS event. NURFS events include: local (pelvic) recurrence of UC (including soft tissue and regional lymph nodes); distant metastasis of UC; or death from any cause. Tumor assessment will be performed using radiographic evaluations.
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HonorHealth Research Institute - Pima - Virginia G. Piper Cancer Care Network
Scottsdale, Arizona, United States
UCLA
Los Angeles, California, United States
USC Norris Cancer Center
Los Angeles, California, United States
Stanford University Medical Center
Palo Alto, California, United States
University Of Colorado
Aurora, Colorado, United States
The Urology Center of Colorado
Denver, Colorado, United States
Yale Cancer Center; Medical Oncology
New Haven, Connecticut, United States
Northwestern University Feinberg School Of Medicine
Chicago, Illinois, United States
University of Chicago; Hematology/Oncology
Chicago, Illinois, United States
University of Iowa Hospital & Clinic; Division of Hematology/Oncology
Iowa City, Iowa, United States
...and 176 more locations
Time frame: Randomization up to time of first occurrence of a NURFS event (up to approximately 50 months)
Percentage of Participants With Adverse Events (AEs)
Percentage of participants with at least one Adverse Event.
Time frame: Screening up to approximately 80 months
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
Percentage of participants with anti-therapeutic antibodies to atezolizumab.
Time frame: Baseline up to approximately 50 months
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale Score
The EQ-5D-5L is a generic preference-based HRQoL questionnaire that provides a single index value for health status and is used to inform pharmacoeconomic evaluations and to measure general health status. Visual analog scale (VAS) allows the patient to indicate, on a scale of 0-100, how his or her health is on the day of assessment, with 100 being the "best imaginable health state" and 0 being the "worst imaginable health state."
Time frame: Day 1 of Cycle 1 up to approximately 50 months (Cycle length = 21 days)
Minimum Observed Serum Atezolizumab Concentration (Cmin)
Minimum observed serum atezolizumab concentration (Cmin) prior to infusion on Day 1 of Cycles 1, 2, 3, and 4; every 8 cycles starting on Cycle 8; at treatment discontinuation; and at 120 days after the last dose of atezolizumab.
Time frame: Pre-dose (Hour 0) on Day 1 of Cycles 1, 2, 3, 4, every 8 cycles from Cycle 8, at treatment discontinuation, 120 days after treatment discontinuation (up to approximately 50 months))(Cycle length = 21 days)
Maximum Observed Serum Atezolizumab Concentration (Cmax)
Maximum observed serum atezolizumab concentration (Cmax) after infusion on Day 1 of Cycle 1.
Time frame: Day 1 of Cycle 1 (Cycle length = 21 days)