Safety and Immunological Effect of Pembrolizumab in Resectable or Borderline Resectable Pancreatic Cancer (UVA-PC-PD101)

August 11, 2021 updated by: Craig L Slingluff, Jr

A Randomized Multicenter Ib/II Study to Assess the Safety & Immunological Effect of Chemoradiation Therapy in Combination With Pembrolizumab Compared to CRT Alone Resectable/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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

68

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic Cancer Center
        • Contact:
          • Justin Weber
          • Phone Number: 855-776-0015
        • Contact:
        • Principal Investigator:
          • Chee-Chee Stucky, MD
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Recruiting
        • Hartford Healthcare
        • Contact:
        • Principal Investigator:
          • Rawad Elias, MD
    • Florida
      • Miami, Florida, United States, 33136
        • Completed
        • University of Miami
    • Massachusetts
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson
        • Contact:
        • Principal Investigator:
          • Matthew Katz, MD
        • Sub-Investigator:
          • Gauri Varadhachary, MD
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia Cancer Center
        • Contact:
        • Principal Investigator:
          • Todd Bauer, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.
  2. Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
  3. Adequate organ function
  4. In subjects requiring biliary decompression, metal stent or drainage using percutaneous transhepatic cholangiogram (PTC) are allowed

Exclusion Criteria:

  1. Immunodeficiency or taking steroid or any other form of immunosuppressive therapy
  2. Has a plastic biliary stent for decompression
  3. Metastatic disease
  4. 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
  5. Active autoimmune disease
  6. Pregnancy or Nursing
  7. Known history of Human Immunodeficiency Virus (HIV) or Hepatitis B or C
  8. Prior monoclonal antibody within 4 weeks prior to study Day 1
  9. Known additional malignancy that is progressing or requires active treatment
  10. Evidence of interstitial lung disease or active, non-infectious pneumonitis
  11. Active infection requiring systemic therapy
  12. 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neodjuvant CRT + Pembrolizumab
Standard neoadjuvant chemoradiation treatment (CRT) with pembrolizumab
Drug: Pembrolizumab
Pembrolizumab administered at a dose of 200 mg IV every 3 weeks on days 1, 22, and 43 during concurrent neoadjuvant chemoradiation treatment
Other Names:
  • Keytruda
  • MK-3475
Radiation: Neoadjuvant Chemoradiation
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)
Active Comparator: Neoadjuvant CRT
Standard neoadjuvant chemoradiation treatment (CRT) alone
Radiation: Neoadjuvant Chemoradiation
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Tumor Infiltrating Lymphocytes (TILs) per high powered field (hpf) in pancreatic tissue (resected tissue).
Time Frame: 2-3 years
2-3 years
Safety: Incidence of Dose-Limiting Toxicities (DLTs)
Time Frame: 2-3 years
2-3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease-free survival (DFS)
Time Frame: 2-4 years
2-4 years
Overall survival (OS)
Time Frame: 2-4 years
2-4 years
Response Rate (RR)
Time Frame: 2-3 years
2-3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Craig L Slingluff, Jr

Investigators

  • Study Chair: Osama Rahma, MD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

November 21, 2014

First Submitted That Met QC Criteria

November 27, 2014

First Posted (Estimate)

December 2, 2014

Study Record Updates

Last Update Posted (Actual)

August 13, 2021

Last Update Submitted That Met QC Criteria

August 11, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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