Study Complete
Sponsor ID
20150195

Safety and Efficacy Study of AMG 820 and Pembrolizumab Combination in Select Advanced Solid Tumor Cancer

Sponsor ID
20150195
Clinicaltrials.gov ID
NCT02713529
EUCTIS ID
N/A
EudraCT ID
2016-001080-36

Study Details

A multi-center Phase 1b/2 study testing the combination of AMG 820 and pembrolizumab in subjects with select advanced solid tumors.

Additional Study Details

Phase
Phase 1/Phase 2
Product
AMG 820
Type
Interventional
Masking
None (Open Label)
Enrollment
117
Additional Study Details

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
Status
Contact Us
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
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