Safety and Immunological Effect of Pembrolizumab in Resectable or Borderline Resectable Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Interventions
- Radiation: Neoadjuvant Chemoradiation
- Registration Number
- NCT02305186
- Lead Sponsor
- Craig L Slingluff, Jr
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 68
- Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.
- Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
- Adequate organ function
- In subjects requiring biliary decompression, metal stent or drainage using percutaneous transhepatic cholangiogram (PTC) are allowed
- Immunodeficiency or taking steroid or any other form of immunosuppressive therapy
- Has a plastic biliary stent for decompression
- Metastatic disease
- Prior treatment for pancreatic cancer (other than 4-8 cycles of Folfirinox) or prior treatment with radiation for other diagnoses to the expected pancreatic cancer treatment area
- Active autoimmune disease
- Pregnancy or Nursing
- Known history of Human Immunodeficiency Virus (HIV) or Hepatitis B or C
- Prior monoclonal antibody within 4 weeks prior to study Day 1
- Known additional malignancy that is progressing or requires active treatment
- Evidence of interstitial lung disease or active, non-infectious pneumonitis
- Active infection requiring systemic therapy
- Prior therapy with an anti-Program Death (PD-1) antibody, anti-PD-L1, anti-PD-L2, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Neodjuvant CRT + Pembrolizumab Pembrolizumab Standard neoadjuvant chemoradiation treatment (CRT) with pembrolizumab Neodjuvant CRT + Pembrolizumab Neoadjuvant Chemoradiation Standard neoadjuvant chemoradiation treatment (CRT) with pembrolizumab Neoadjuvant CRT Neoadjuvant Chemoradiation Standard neoadjuvant chemoradiation treatment (CRT) alone
- Primary Outcome Measures
Name Time Method Number of Tumor Infiltrating Lymphocytes (TILs) per high powered field (hpf) in pancreatic tissue (resected tissue). 2-3 years Safety: Incidence of Dose-Limiting Toxicities (DLTs) 2-3 years
- Secondary Outcome Measures
Name Time Method Disease-free survival (DFS) 2-4 years Overall survival (OS) 2-4 years Response Rate (RR) 2-3 years
Trial Locations
- Locations (6)
Hartford HealthCare
🇺🇸Hartford, Connecticut, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Mayo Clinic Cancer Center
🇺🇸Phoenix, Arizona, United States
University of Miami
🇺🇸Miami, Florida, United States
MD Anderson
🇺🇸Houston, Texas, United States
University of Virginia Cancer Center
🇺🇸Charlottesville, Virginia, United States