Condition
Solid Tumor
Estimated Enrollment: 725
Age Group: 18 Years and older (Adult, Senior)
Gender: All
Study Type: Interventional
Study Design Allocation: Intervention Model: Single Group Assignment|Masking: Open Label|Primary Purpose: Treatment
Study ID Numbers: MO29518|2015-000269-30
Study First Received: May 28, 2015
Last Updated: November 1, 2016
Estimated Primary Completion Date: December 2020
Primary Outcome Measures:
NPR: Percentage of Participants with CR, PR, or SD According to RECIST v1.1 or Disease-Specific Criteria at 18 Weeks|Minimum Plasma Concentration Observed (Cmin) of Atezolizumab|NPR: Percentage of Participants with CR, PR, or SD According to RECIST v1.1 or Disease-Specific Criteria at 24 Weeks or According to Modified RECIST Criteria at 18 and 24 Weeks|Overall Response Rate (ORR): Percentage of Participants with CR or PR According to RECIST v1.1 or Disease-Specific Criteria or According to Modified RECIST Criteria|Percentage of Participants by Best Overall Response (BOR) According to RECIST v1.1 or Disease-Specific Criteria or According to Modified RECIST Criteria|Clinical Benefit Rate (CBR): Percentage of Participants with CR, PR, or SD Lasting for >/=6 Weeks According to RECIST v1.1 or Disease-Specific Criteria or According to Modified RECIST Criteria|Duration of Objective Response (DOR) According to RECIST v1.1 or Disease-Specific Criteria or According to Modified RECIST Criteria|Progression-Free Survival (PFS) According to RECIST v1.1 or Disease-Specific Criteria or According to Modified RECIST Criteria|Time to Progression (TTP) According to RECIST v1.1 or Disease-Specific Criteria or According to Modified RECIST Criteria|Overall Survival (OS)|Percentage of Participants with Adverse Events|Mean Number of Cycles of Atezolizumab|Mean Maximum Dose of Atezolizumab|Percentage of Participants with Anti-Atezolizumab Antibodies|Maximum Plasma Concentration Observed (Cmax) of Atezolizumab
Sponsors and Collaborators:
Hoffmann-La Roche
Website Link: https://ClinicalTrials.gov/show/NCT02458638
