Azacitidine and Pembrolizumab in Pancreatic Cancer
Status:
Active, not recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
The purpose of this study is to determine the effectiveness of combining immune therapy,
pembrolizumab, with a hypomethylating agent, azacitidine, for pancreatic cancer. People who
have advanced pancreatic cancer with disease progression on first-line therapy are usually
treated with a second chemotherapy regimen. However, there is no single accepted chemotherapy
regimen and national guidelines recommend chemotherapy or clinical trial participation. In
this study, all study subjects will receive a combination of immune therapy (every 3 weeks)
and a hypomethylating agent (every 4 weeks). To date, studies have shown that combining a
hypomethylating agent with chemotherapy or immune therapy may benefit patients across
different solid tumor types including pancreatic cancer. Preclinical data in a mouse model of
pancreatic cancer demonstrates improvement in survival with the combination of a
hypomethylating agent and immune therapy. However, the use of single agent hypomethylating
agent or immune therapy has not been shown to be effective in patients with pancreatic
cancer. The one exception, to date, is the use of immune therapy in those individuals with a
particular genetic feature known as mismatch repair deficiency and microsatellite
instability. The combination of immune therapy and a hypomethylating agent has not been
studied in human subjects and is not approved by the FDA for use in pancreatic cancer.
This is a non-randomized, single-center, open-label trial of pembrolizumab and azacitidine in
subjects with locally advanced or metastatic pancreatic adenocarcinoma. Approximately 31
individuals will be asked to participate in this study.