Clinical Trial: Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase III, Multicenter, Randomized, Placebo-Controlled Study of Atezolizumab (Anti−PD-L1 Antibody) as Monotherapy and in Combination With Platinum-Based Chemotherapy in Patients With Untreated
Brief Summary: A Phase III, randomised study of atezolizumab alone and in combination with chemotherapy versus chemotherapy alone in participants with untreated advanced urothelial cancer.
Detailed Summary:
Sponsor: Hoffmann-La Roche
Current Primary Outcome:
- Progression-Free Survival (PFS) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in Participants Treated with Atezolizumab Combination Therapy Compared With Placebo Arm [ Time Frame: Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (assessed at baseline, every 9 weeks for 54 weeks and every 12 weeks thereafter up to 44 months) ]
- Overall Survival (OS) [ Time Frame: Baseline until death due to any cause (up to 44 months) ]
- Percentage of Participants with Adverse Events (AEs) Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Baseline up to 44 months ]
Original Primary Outcome:
- Progression-Free Survival (PFS) Assessed by Investigator Using RECIST V1.1 [ Time Frame: Baseline up to Disease progression or death, whichever occurred first (up to 33 months) ]
- Overall Survival (OS) [ Time Frame: Baseline until death due to any cause (up to 33 months) ]
- Percentage of Participants with Adverse Events (AEs) Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Baseline up to 33 months ]
Current Secondary Outcome:
- Percentage of Participants with Best Overall Response of Complete Response (CR) or Partial Response (PR) Assessed by Investigator Using RECIST v1.1 [ Time Frame: Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (assessed at baseline, every 9 weeks for 54 weeks and every 12 weeks thereafter up to 44 months) ]
- Duration of response (DOR) Assessed by Investigator Using RECIST v1.1 [ Time Frame: From first documented objective response (CR or PR) to disease progression, death, or loss of follow-up, whichever occurs first (assessed at baseline, every 9 weeks for 54 weeks and every 12 weeks thereafter up to 44 months) ]
- Percentage of Participants Who Were Alive at Year 1 [ Time Frame: Year 1 ]
- Percentage of Participants Who Were Alive and Progression Free at Year 1 Using RECIST v1.1 [ Time Frame: Year 1 ]
- Median Time to Deterioration in Global Health Status as Measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score [ Time Frame: Cycle 1 Day 1 (cycle length = 21 days), on Day 1 of each subsequent cycle up treatment discontinuation visit (up to 44 months) ]
- Median Time to Deterioration in Physical Function as Measured by the EORTC QLQ-C30 Score [ Time Frame: Cycle 1 Day 1 (cycle length = 21 days), on Day 1 of each subsequent cycle up treatment discontinuation visit (up to 44 months) ]
- Maximum Atezolizumab Serum Concentration [ Time Frame: Pre-dose,30 min post-end of infusion(infusion length=60min) on Cycle 1 Day 1(1 cycle=21days), pre-dose on Day 1 of Cycles 2,3,4,8 and every 8th cycle thereafter(up to 44months),120 days after last dose or treatment discontinuation visit(up to 44 months) ]
- Minimum Atezolizumab Serum Concentration [ Time Frame: Pre-dose on Day 1 (1 cycle = 21 days) of Cycles 1,2,3,4,8 and every 8th cycle thereafter (up to 44 months) ]
- Percentage of Participants With Anti-Therapeutic (Anti-Atezolizumab) Antibodies (ATAs) [ Time Frame: Baseline up to 44 months ]
- Progression-Free Survival (PFS) Assessed by Investigator Using RECIST v1.1 in Participants Treated with Atezolizumab Montotherapy Compared With Placebo Arm [ Time Frame: Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (assessed at baseline, every 9 weeks for 54 weeks and every 12 weeks thereafter up to 44 months) ]
Original Secondary Outcome:
- Percentage of Participants with Objective Response, assessed using RECIST v1.1 [ Time Frame: Baseline up to Disease progression or death, whichever occurred first (up to 33 months) ]
- Duration of response (DOR) Assessed Using RECIST v1.1 [ Time Frame: Baseline up to Disease progression or death, whichever occurred first (up to 33 months) ]
- PFS Assessed by Independent Review Facility (IRF) Using RECIST v1.1 [ Time Frame: Baseline up to Disease progression or death, whichever occurred first (up to 33 months) ]
- Percentage of Participants Who Were Alive at Year 1 [ Time Frame: Year 1 ]
- Percentage of Participants Who Were Alive and Progression Free at Year 1 [ Time Frame: Year 1 ]
- Median Time to Deterioration in Global Health Status as Measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score [ Time Frame: Cycle 1 Day 1 (cycle length = 21 days), on Day 1 of each subsequent cycle up treatment discontinuation visit (up to 33 months) ]
- Median Time to Deterioration in Physical Function as Measured by the EORTC QLQ-C30 Score [ Time Frame: Cycle 1 Day 1 (cycle length = 21 days), on Day 1 of each subsequent cycle up treatment discontinuation visit (up to 33 months) ]
- Maximum Atezolizumab Serum Concentration [ Time Frame: Pre-dose, 30 min post-dose on Cycle 1 Day 1 (cycle length = 21 days), pre-dose on Day 1 of Cycles 2,3,4,8 and every 8th cycle thereafter (up to 33 months), 120 days after last dose or treatment discontinuation visit (up to 33 months overall) ]
- Minimum Atezolizumab Serum Concentration [ Time Frame: Pre-dose Cycle 1 Day 1 (cycle length = 21 days), pre-dose on Day 1 of Cycles 2,3,4,8 and every 8th cycle thereafter (up to 33 months) ]
- Percentage of Participants With Anti-Therapeutic (Anti-Atezolizumab) Antibodies (ATAs) [ Time Frame: Baseline, Up to 33 months ]
Information By: Hoffmann-La Roche
Dates:
Date Received: June 17, 2016
Date Started: June 30, 2016
Date Completion: July 30, 2020
Last Updated: April 24, 2017
Last Verified: April 2017