Status:
UNKNOWN
Safety and Immunological Effect of Pembrolizumab in Resectable or Borderline Resectable Pancreatic Cancer
Lead Sponsor:
Craig L Slingluff, Jr
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 (surgica...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT02305186
Start Date
March 1 2015
End Date
December 1 2022
Last Update
August 13 2021
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic Cancer Center
Phoenix, Arizona, United States, 85054
2
Hartford HealthCare
Hartford, Connecticut, United States, 06102
3
University of Miami
Miami, Florida, United States, 33136
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215