Phase Ib/II Study to Assess the Safety and the Immunological Effect of Chemoradiation Therapy (CRT) in Combination with Pembrolizumab (MK-3475) Compared to CRT Alone in Patients With Resectable or Borderline Resectable Pancreatic Cancer

Summary

The purpose of this clinical trial is to study an experimental drug called pembrolizumab or MK-3475 for use in combination with chemotherapy and radiation therapy for patients with resectable (surgical removal) or borderline resectable pancreatic cancer. In general, pancreatic cancer that cannot be removed by surgery is sometimes treated with chemotherapy and radiation therapy, called neoadjuvant treatment, to shrink the tumor so that surgery might be possible. However, this is not always effective at shrinking the tumor enough to allow it to be removed with surgery. Recent discoveries suggest that the investigators own immune system might have a role in controlling the growth of tumors. Drugs such as pembrolizumab can stimulate the immune system against cancer. The purpose of this study is to investigate whether pembrolizumab can be used safely during neoadjuvant treatment and can improve the body's immune response against pancreatic cancer. Pembrolizumab has been approved for treatment of patients with melanoma but has not been proven to be safe or helpful in patients with pancreatic cancer and is not approved by the U.S. Food and Drug Administration (FDA) for this purpose.

General Information

NCT#: NCT02305186
Study ID: 17801
Trial Phase: Phase I/II

Trial Sponsor: University of Virginia
Therapies Used in This Trial: Radiation Therapy, Capecitabine, Pembrolizumab