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

• ClinicalTrials.gov Identifier: NCT02305186
• Recruitment Status: Unknown
• First Posted: December 2, 2014
• Last Update Posted: August 13, 2021
• Sponsor: Craig L Slingluff, Jr
• Information provided by (Responsible Party): Craig L Slingluff, Jr, University of Virginia

Tracking Information

• First Submitted Date: November 21, 2014
• First Posted Date: December 2, 2014
• Last Update Posted Date: August 13, 2021
• Study Start Date: March 2015
• Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 27, 2014)

• 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 ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 27, 2014)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Immunological Effect of Pembrolizumab in Resectable or Borderline Resectable Pancreatic Cancer
• 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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Pancreatic Cancer

Intervention

• 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)

Study Arms

• Experimental: Neodjuvant CRT + Pembrolizumab
  Standard neoadjuvant chemoradiation treatment (CRT) with pembrolizumab
  Interventions:

  • Drug: Pembrolizumab
  • Radiation: Neoadjuvant Chemoradiation
• Active Comparator: Neoadjuvant CRT
  Standard neoadjuvant chemoradiation treatment (CRT) alone
  Intervention: Radiation: Neoadjuvant Chemoradiation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: November 15, 2020): 68
• Original Estimated Enrollment (submitted: November 27, 2014): 56
• Estimated Study Completion Date: December 2022
• Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)

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 (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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02305186
• Other Study ID Numbers: 17801
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Craig L Slingluff, Jr, University of Virginia
• Original Responsible Party: Osama Rahma, MD, University of Virginia, Assistant Professor of Medicine, Division of Hematology/Oncology
• Current Study Sponsor: Craig L Slingluff, Jr
• Original Study Sponsor: Osama Rahma, MD
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Virginia
• Verification Date: August 2021