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

Pancreatic Cancer Clinical Trial

— UVA-PC-PD101  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02305186
• Other study ID #: 17801
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 2015
• Est. completion date: December 2022

Study information

• Verified date: August 2021
• Source: University of Virginia
• Contact: Justin Alicea
• Phone: 434-243-5350
• Email: xzy7tw[@]virginia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

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

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)

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	University of Virginia Cancer Center	Charlottesville	Virginia
United States	Hartford HealthCare	Hartford	Connecticut
United States	MD Anderson	Houston	Texas
United States	University of Miami	Miami	Florida
United States	Mayo Clinic Cancer Center	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Craig L Slingluff, Jr

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Tumor Infiltrating Lymphocytes (TILs) per high powered field (hpf) in pancreatic tissue (resected tissue).		2-3 years
Primary	Safety: Incidence of Dose-Limiting Toxicities (DLTs)		2-3 years
Secondary	Disease-free survival (DFS)		2-4 years
Secondary	Overall survival (OS)		2-4 years
Secondary	Response Rate (RR)		2-3 years