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Clinical Trial Record

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Safety and Immunological Effect of Pembrolizumab in Resectable or Borderline Resectable Pancreatic Cancer

2015-03

2022-12

2022-12

68

Study Overview

Safety and Immunological Effect of Pembrolizumab in 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.

N/A

  • Pancreatic Cancer
  • DRUG: Pembrolizumab
  • RADIATION: Neoadjuvant Chemoradiation
  • 17801

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 Registration Dates Results Reporting Dates Study Record Updates

2014-11-21  

N/A  

2021-08-11  

2014-11-27  

N/A  

2021-08-13  

2014-12-02  

N/A  

2021-08  

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/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

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)
Primary Outcome MeasuresMeasure DescriptionTime Frame
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 MeasuresMeasure DescriptionTime Frame
Disease-free survival (DFS)2-4 years
Overall survival (OS)2-4 years
Response Rate (RR)2-3 years

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

Name: Justin Alicea

Phone Number: 434-243-5350

Email: xzy7tw@virginia.edu

Study Contact Backup

Name: Katie Rea

Phone Number: 434-924-8574

Email: kaw3j@virginia.edu

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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

Collaborators and Investigators

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

    • STUDY_CHAIR: Osama Rahma, MD, Dana-Farber Cancer Institute

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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