NCT02546531

Defactinib Combined With Pembrolizumab and Gemcitabine in Patients With Advanced Cancer

Phase I Study of Defactinib Combined With Pembrolizumab and Gemcitabine in Patients With Advanced Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In pancreatic cancer, targeting the tumor microenvironment has become a promising therapeutic strategy. Focal adhesion kinase (FAK) pathway activation is essential for promoting a fibrotic and inflammatory tumor microenvironment, and FAK inhibitors have demonstrated reasonable anti-tumor activity in the preclinical setting. Furthermore, a maximal synergetic effect was achieved when a FAK inhibitor was given in combination with a PD-1 antagonist and chemotherapy in multiple pancreas tumor animal models. This supports the concept of using FAK inhibitors to reduce stromal fibrosis during checkpoint immunotherapeutic treatment. Therefore, these robust preclinical findings will be tested in the proposed phase I trial.

Conditions

• Advanced Solid Tumors
• Solid Tumors
• Pancreatic Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Defactinib
BIOLOGICAL	Pembrolizumab
DRUG	Gemcitabine

Timeline

• Start date: 2016-02-03
• Primary completion: 2017-11-17
• Completion: 2021-01-11
• First posted: 2015-09-11
• Last updated: 2021-07-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study