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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
Pembrolizumab administered at a dose of 200 mg IV every 3 weeks on days 1, 22, and 43 during concurrent neoadjuvant chemoradiation treatment
Chemoradiation with capecitabine (825 mg/m2 orally twice daily, Monday through Friday, on days of radiation only) and radiation (50.4 Gy in 28 fractions over 28 days)
Mayo Clinic Cancer Center
Phoenix, Arizona, United States
RECRUITINGHartford HealthCare
Hartford, Connecticut, United States
RECRUITINGUniversity of Miami
Miami, Florida, United States
COMPLETEDDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGMD Anderson
Houston, Texas, United States
RECRUITINGUniversity of Virginia Cancer Center
Charlottesville, Virginia, United States
RECRUITINGNumber of Tumor Infiltrating Lymphocytes (TILs) per high powered field (hpf) in pancreatic tissue (resected tissue).
Time frame: 2-3 years
Safety: Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: 2-3 years
Disease-free survival (DFS)
Time frame: 2-4 years
Overall survival (OS)
Time frame: 2-4 years
Response Rate (RR)
Time frame: 2-3 years
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