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

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ClinicalTrials.gov Identifier: NCT02305186
Recruitment Status : Recruiting
First Posted : December 2, 2014
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Craig L Slingluff, Jr, University of Virginia

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 (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.


Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Pembrolizumab Radiation: Neoadjuvant Chemoradiation Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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:
  • MK-3475
  • Keytruda

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

Secondary Outcome Measures :
  1. Disease-free survival (DFS) [ Time Frame: 2-4 years ]
  2. Overall survival (OS) [ Time Frame: 2-4 years ]
  3. Response Rate (RR) [ Time Frame: 2-3 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02305186


Contacts
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Contact: Steve Fowler 434-243-4730 saf2qh@virginia.edu

Locations
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United States, Arizona
Mayo Clinic Cancer Center Recruiting
Phoenix, Arizona, United States, 85054
Contact: Clinical Trials Office- All Mayo Clinic Locations    855-776-0015      
Principal Investigator: Chee-Chee Stucky, MD         
United States, Florida
University of Miami Active, not recruiting
Miami, Florida, United States, 33136
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Katherine Metayer    617-632-6316    KatherineA_Metayer@DFCI.HARVARD.EDU   
Contact: Osama Rahma, MD       OsamaE_Rahma@DFCI.HARVARD.EDU   
Principal Investigator: Osama Rahma, MD         
United States, Texas
MD Anderson Recruiting
Houston, Texas, United States, 77030
Contact: Kandice Rachal    713-745-8434    KRRachal@mdanderson.org   
Principal Investigator: Matthew Katz, MD         
Sub-Investigator: Gauri Varadhachary, MD         
United States, Virginia
University of Virginia Cancer Center Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Rachael Reed    434-982-6584    rmr3bx@hscmail.mcc.virginia.edu   
Principal Investigator: Todd Bauer, MD         
Sponsors and Collaborators
Craig L Slingluff, Jr
Investigators
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Study Chair: Osama Rahma, MD Dana-Farber Cancer Institute

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Responsible Party: Craig L Slingluff, Jr, Director of the UVA Human Immune Therapy Center, University of Virginia
ClinicalTrials.gov Identifier: NCT02305186     History of Changes
Other Study ID Numbers: 17801
First Posted: December 2, 2014    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Keywords provided by Craig L Slingluff, Jr, University of Virginia:
Immunotherapy
Neoadjuvant
Resectable
Borderline resectable
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents