A Study to Evaluate the Safety and Immunological Effect of Pembrolizumab in Resectable or Borderline Resectable Pancreatic Cancer


About this study

The purpose of this study is to investigate whether pembrolizumab (MK-3475 ) 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST).
  • 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 Criteria:

  • 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 or prior treatment with radiation for other diagnoses to the expected pancreatic cancer treatment area.
  • Active autoimmune disease.
  • Pregnant 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Chee-Chee Stucky, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information


Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available


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