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 : Unknown
Verified August 2021 by Craig L Slingluff, Jr, University of Virginia.
Recruitment status was: Recruiting
First Posted : December 2, 2014
Last Update Posted : August 13, 2021
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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 |
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Pancreatic Cancer | Drug: Pembrolizumab Radiation: Neoadjuvant Chemoradiation | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 68 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | March 2015 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | December 2022 |
Arm | Intervention/treatment |
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Experimental: Neodjuvant CRT + Pembrolizumab
Standard neoadjuvant chemoradiation treatment (CRT) with pembrolizumab
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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:
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
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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) |
- Number of Tumor Infiltrating Lymphocytes (TILs) per high powered field (hpf) in pancreatic tissue (resected tissue). [ Time Frame: 2-3 years ]
- Safety: Incidence of Dose-Limiting Toxicities (DLTs) [ Time Frame: 2-3 years ]
- Disease-free survival (DFS) [ Time Frame: 2-4 years ]
- Overall survival (OS) [ Time Frame: 2-4 years ]
- 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 |
Inclusion Criteria:
- Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.
- 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 (other than 4-8 cycles of Folfirinox) or prior treatment with radiation for other diagnoses to the expected pancreatic cancer treatment area
- Active autoimmune disease
- Pregnancy 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
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
Contact: Justin Alicea | 434-243-5350 | xzy7tw@virginia.edu | |
Contact: Katie Rea | 434-924-8574 | kaw3j@virginia.edu |
United States, Arizona | |
Mayo Clinic Cancer Center | Recruiting |
Phoenix, Arizona, United States, 85054 | |
Contact: Justin Weber 855-776-0015 | |
Contact weber.justin@mayo.edu | |
Principal Investigator: Chee-Chee Stucky, MD | |
United States, Connecticut | |
Hartford HealthCare | Recruiting |
Hartford, Connecticut, United States, 06102 | |
Contact: Leah Persky leah.persky@hhchealth.org | |
Principal Investigator: Rawad Elias, MD | |
United States, Florida | |
University of Miami | Completed |
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: Edsel Esquivel EFEsquivel@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: Adela Mahmutovic am6bd@hscmail.mcc.virginia.edu | |
Principal Investigator: Todd Bauer, MD |
Study Chair: | Osama Rahma, MD | Dana-Farber Cancer Institute |
Responsible Party: | Craig L Slingluff, Jr, Director of the UVA Human Immune Therapy Center, University of Virginia |
ClinicalTrials.gov Identifier: | NCT02305186 |
Other Study ID Numbers: |
17801 |
First Posted: | December 2, 2014 Key Record Dates |
Last Update Posted: | August 13, 2021 |
Last Verified: | August 2021 |
Immunotherapy Neoadjuvant Resectable Borderline resectable |
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases |
Endocrine System Diseases Pembrolizumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |