Study Complete
Sponsor ID
20150195
Safety and Efficacy Study of AMG 820 and Pembrolizumab Combination in Select Advanced Solid Tumor Cancer
Study Details
A multi-center Phase 1b/2 study testing the combination of AMG 820 and pembrolizumab in subjects with select advanced solid tumors.
Protocol Summary
Primary Outcome Measures
Number of participants with treatment related adverse events as assessed by CTCAE version 4.0
Timeframe: 12 months
Objective response rate of tumors using irRECIST criteria for total measureable tumor burden
Timeframe: 12 months
Number of participants with treatment emergent adverse events as assessed by CTCAE version 4.0
Timeframe: 12 months
Secondary Outcome Measures
Objective response rate of tumors using RECIST 1.1 criteria for total measurable tumor burden
Timeframe: 12 months
Maximum observed concentration [Cmax] of AMG820
Timeframe: 12 months
CD4, CD8, and CD68 cell numbers in pre-treatment tumor biopsy tissue
Timeframe: 12 months
Minimum observed concentration [Cmin] of AMG 820
Timeframe: 12 months
Area Under the Curve [AUC] of AMG820
Timeframe: 12 months
Locations
Location
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
Status
Recruiting
Location
Princess Margaret Cancer Centre
Toronto, ON, Canada, M5G 2M9
Status
Recruiting
Location
Research Site
Parkville, VIC, Australia, 3050
Status
Recruiting
Location
Research Site
Grand Rapids, MI, United States, 49546
Status
Recruiting
Location
Research Site
Camperdown, NSW, Australia, 2050
Status
Recruiting
Location
Research Site
New York, NY, United States, 10021
Status
Recruiting
Showing {first} - {last} of {total} Results