Recruiting
Phase 1
Phase 2

Pembrolizumab

Sponsor:

Craig L Slingluff, Jr

Code:

NCT02305186

Conditions

Pancreatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pembrolizumab

Neoadjuvant Chemoradiation

Study Details

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.

Conditions

Pancreatic Cancer

Study ID

NCT02305186

Start date

Mar, 2015

Status verified date

Aug, 2021

Completion date

Dec, 2022

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

68 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Neodjuvant CRT + Pembrolizumab

Standard neoadjuvant chemoradiation treatment (CRT) with pembrolizumab

active comparator: Neoadjuvant CRT

Standard neoadjuvant chemoradiation treatment (CRT) alone

Interventions

Pembrolizumab

Pembrolizumab administered at a dose of 200 mg IV every 3 weeks on days 1, 22, and 43 during concurrent neoadjuvant chemoradiation treatment

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 measure

  • 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 ]

Central Contacts and Locations

Locations

Mayo Clinic Cancer Center

Recruiting

Phoenix, Arizona, United States, 85054

Contacts

Principal Investigator:

Chee-Chee Stucky, MD

Hartford HealthCare

Recruiting

Hartford, Connecticut, United States, 06102

Contacts

Principal Investigator:

Rawad Elias, MD

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Principal Investigator:

Osama Rahma, MD

MD Anderson

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Matthew Katz, MD

University of Virginia Cancer Center

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Principal Investigator:

Todd Bauer, MD

More Information

Sponsor

Craig L Slingluff, Jr

Last update posted

Aug 13, 2021

Last verified

Aug, 2021

Keywords

  • Immunotherapy
  • Neoadjuvant
  • Resectable
  • Borderline resectable

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Craig L Slingluff, Jr on 2021-08-13.