Clinical Trial: A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma After Surgical Resection [IMvigor010]
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase III, Open-Label, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Versus Observation as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Uro
Brief Summary: 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 urothelial carcinoma (UC) who are at high risk for recurrence following resection. Eligible participants will be randomized by a 1:1 ratio into atezolizumab group or control group.
Detailed Summary:
Sponsor: Hoffmann-La Roche
Current Primary Outcome: Disease-Free Survival (DFS), as Assessed by Investigator [ Time Frame: Randomization up to first occurrence of DFS event (assessed at screening/randomization, every 12 weeks after randomization in first 3 years, every 24 weeks for Years 4 and 5, and at Year 6) ]
Original Primary Outcome: Disease-Free Survival (DFS) [ Time Frame: From randomization up to year 6 ]
Current Secondary Outcome:
- Overall Survival (OS) [ Time Frame: Randomization until death due to any cause (up to approximately 6.5 years) ]
- Disease-Specific Survival (DSS), as Assessed by Investigator [ Time Frame: Randomization until death due to UC (up to approximately 6.5 years) ]DSS is defined as the time from randomization until the date of death from UC.
- Distant Metastasis-Free Survival (DMFS) [ Time Frame: Randomization up to diagnosis of distant metastases or death from any cause (assessed at screening/randomization, every 12 weeks after randomization in first 3 years, every 24 weeks for Years 4 and 5, and at Year 6) ]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.
- Non-Urinary Tract Recurrence-Free Survival (NURFS) [ Time Frame: Randomization up to time of first occurrence of a NURFS event (assessed at screening/randomization, every 12 weeks after randomization in first 3 years, every 24 weeks for Years 4 and 5, and at Year 6) ]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.
- Percentage of Participants with Adverse Events (AEs) [ Time Frame: Screening up to approximately 1 year ]
- Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab [ Time Frame: Pre-dose (Hour 0) on Day 1 of Cycles 1, 2, 3, 4, and every 8 cycles from Cycle 8; at treatment discontinuation (up to 1 year); 90 days after last dose (last dose = up to 1 year) (Cycle length = 21 days) ]
- European Quality of Life (EuroQoL) Group 5-Dimension 5-Level (EQ-5D-5L) Self Report Questionnaire Health Utility Score [ Time Frame: Day 1 of Cycle 1 up to 6 (detailed timeframe is provided in outcome description section) ]Detailed timeframe: Day 1 of Cycles 1, 3, 5, 7, 9, 11, 13, 15, at treatment/observation period discontinuation (up to 1 year), thereafter every 12 weeks up to Year 3 and then every 24 weeks up to Year 5, at Year 6, additionally at 6, 12, 24 weeks after disease recurrence (any time up to 6 years) (Cycle length = 21 days)
- Minimum Observed Serum Atezolizumab Concentration (Cmin) [ Time Frame: Pre-dose (Hour 0) on Day 1 of Cycles 1, 2, 3, 4, every 8 cycles from Cycle 8, at treatment discontinuation (up to 1 year), 120 days after treatment discontinuation (up to 1 year 4 months) ]
- Maximum Observed Serum Atezolizumab Concentration (Cmax) [ Time Frame: Pre-dose (Hour 0) and 0.5 hours after end of infusion on Day 1 of Cycle 1 (infusion duration = 60 minutes, Cycle length = 21 days) ]
Original Secondary Outcome:
- Overall Survival (OS) [ Time Frame: From randomization up to year 6 ]
- Disease-Specific Survival (DSS) [ Time Frame: From randomization up to year 6 ]
- Distant Metastasis-Free Survival (DMFS) [ Time Frame: From randomization up to year 6 ]
- Number of Participants with Adverse Events (AEs) [ Time Frame: From randomization up to 30 days after the last dose of study treatment ]
- Percentage of Anti-Therapeutic Antibody (ATA) Response to MPDL3280A [ Time Frame: From randomization up to 120 days after the last dose of study treatment ]
- Maximum Observed Serum MPDL3280A Concentration (Cmax) [ Time Frame: From randomization up to 120 days after the last dose of study treatment ]
- Score of Participant-Reported Health Status in the EuroQol 5-Dimension, 5-Level Version (EQ-5D-5L) Questionnaire [ Time Frame: From randomization up to year 6 ]
Information By: Hoffmann-La Roche
Dates:
Date Received: May 19, 2015
Date Started: June 29, 2017
Date Completion: April 30, 2022
Last Updated: April 24, 2017
Last Verified: April 2017