NCT02713529

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

A Phase1b/2 Study Assessing Safety and Anti-tumor Activity of AMG 820 in Combination With Pembrolizumab in Select Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: AmMax Bio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Phase 1b is AMG 820 dose determining and aimed at assessing the safety and tolerability of the selected starting dose of AMG 820 in combination with pembrolizumab. Phase 2 of the study will further evaluate safety and tolerability and additionally test whether AMG 820 can enhance the anti-tumor activity observed historically with pembrolizumab alone and/or overcome lack of response to pembrolizumab monotherapy in subjects with select solid tumors.

Conditions

• Pancreatic Cancer
• Colorectal Cancer
• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	AMG820 and pembrolizumab	Treatment with AMG820 and pembrolizumab

Timeline

• Start date: 2016-04-14
• Primary completion: 2019-01-02
• Completion: 2019-05-17
• First posted: 2016-03-18
• Last updated: 2023-01-20
• Results posted: 2020-06-01

Locations

15 sites across 6 countries: United States, Australia, Belgium, Canada, Germany, Spain

Regulatory

• FDA-regulated drug study