Clinical Trials /

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

NCT02305186

Description:

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.

Related Conditions:
  • Pancreatic Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Safety and Immunological Effect of Pembrolizumab in Resectable or Borderline Resectable Pancreatic Cancer
  • Official Title: A Randomized Multicenter Phase Ib/II Study to Assess the Safety and the Immunological Effect of Chemoradiation Therapy (CRT) in Combination With Pembrolizumab (MK-3475) Compared to CRT Alone in Patients With Resectable or Borderline Resectable Pancreatic Cancer

Clinical Trial IDs

  • ORG STUDY ID: 17801
  • NCT ID: NCT02305186

Conditions

  • Pancreatic Cancer

Interventions

DrugSynonymsArms
PembrolizumabMK-3475, KeytrudaNeodjuvant CRT + Pembrolizumab

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Neodjuvant CRT + PembrolizumabExperimentalStandard neoadjuvant chemoradiation treatment (CRT) with pembrolizumab
  • Pembrolizumab
Neoadjuvant CRTActive ComparatorStandard neoadjuvant chemoradiation treatment (CRT) alone

    Eligibility Criteria

            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 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
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Number of Tumor Infiltrating Lymphocytes (TILs) per high powered field (hpf) in pancreatic tissue (resected tissue).
    Time Frame:2-3 years
    Safety Issue:
    Description:

    Secondary Outcome Measures

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

    Details

    Phase:Phase 1/Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Craig L Slingluff, Jr

    Trial Keywords

    • Immunotherapy
    • Neoadjuvant
    • Resectable
    • Borderline resectable

    Last Updated