Pancreatic Cancer UVA-PC-PD101 (GI)

Randomized Multicenter Phase Ib/II study to assess the safety and the immunological effect of chemoradiation therapy (CRT) in combination with MK-3475 (anti-PD1) to CRT alone in patients with resectable or borderline resectable pancreatic cancer

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.

Eligibility Criteria:
  • Subjects for whom the clinical, radiographic, and pathologic evidence support a diagnosis of pancreatic adenocarcinoma, with histology confirmatory or suspicious for adenocarcinoma
  • Must be determined to meet the criteria for resectable or borderline resectable pancreatic cancer based on the M.D. Anderson Cancer Center (MDACC) and Alliance Intergroup Criteria classification 
  • Given the increase use of neoadjuvant chemotherapy with FLOFIRINOX in the neoadjuvant setting, patients are now allowed to be treated with 4-6 cycles of FLOFIRINOX prior to randomization to CRT +pembrolizumab vs. CRT alone
  • Not had Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
  • Not had an active automimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
This study is for patients age 18 and older. 
Available at: Hartford HealthCare, Hospital of Central Connecticut, Midstate Medical Center, William Backus Hospital.

Cancer Clinical Research Office