drugset / Trial / NCT02703714
Pembrolizumab and GM-CSF in Biliary Cancer
Phase 2
Completed
42 enrolled
Robin Kate Kelley
American Society of Clinical Oncology · collabMerck Sharp & Dohme LLC · collabNational Cancer Institute (NCI) · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | sargramostim | Protein / enzyme biologic | 250 ug | Subcutaneous |