drugset / Trial / NCT02703714

Pembrolizumab and GM-CSF in Biliary Cancer

NCT02703714 ↗

NaSingle-groupOpen-labelTreatment

Summary

This is an open label phase II trial to examine efficacy and safety of a novel combination of pembrolizumab plus induction GM-CSF in patients with advanced biliary cancers treated at University of California, San Francisco (UCSF). This phase II study will examine the efficacy and safety of the novel combination of pembrolizumab plus induction GM-CSF in advanced biliary cancer patients with the hypotheses that the combination may increase proportion of patients with overall response compared to contemporary historical controls, with acceptable safety.

Timeline

Start
2016-05-06
Primary completion
2020-12-31
Completion
2020-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject sargramostim Protein / enzyme biologic 250 ug Subcutaneous

Indications