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

NCT02305186 | Unknown Phase 1 DMC

• 1 other identifier: 17801
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 6

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

Keywords

Immunotherapy; Neoadjuvant; Resectable; Borderline resectable

Outcome Measures

Primary Outcomes (2)

• Number of Tumor Infiltrating Lymphocytes (TILs) per high powered field (hpf) in pancreatic tissue (resected tissue).

  2-3 years

• Safety: Incidence of Dose-Limiting Toxicities (DLTs)

  2-3 years

Secondary Outcomes (3)

• Disease-free survival (DFS)

  2-4 years

• Overall survival (OS)

  2-4 years

• Response Rate (RR)

  2-3 years

Study Arms (2)

Neodjuvant CRT + Pembrolizumab

EXPERIMENTAL

Standard neoadjuvant chemoradiation treatment (CRT) with pembrolizumab

Drug: Pembrolizumab; Radiation: Neoadjuvant Chemoradiation

Neoadjuvant CRT

ACTIVE COMPARATOR

Standard neoadjuvant chemoradiation treatment (CRT) alone

Radiation: Neoadjuvant Chemoradiation

Interventions

Pembrolizumab DRUG

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

Also known as: MK-3475, Keytruda

Neodjuvant CRT + Pembrolizumab

Neoadjuvant Chemoradiation RADIATION

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)

Neoadjuvant CRT; Neodjuvant CRT + Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Craig L Slingluff, Jr: lead

Study Sites (6)

Mayo Clinic Cancer Center

Phoenix, Arizona, 85054, United States

RECRUITING

Hartford HealthCare

Hartford, Connecticut, 06102, United States

RECRUITING

University of Miami

Miami, Florida, 33136, United States

COMPLETED

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

MD Anderson

Houston, Texas, 77030, United States

RECRUITING

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

pembrolizumab; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Officials

• Osama Rahma, MD

  Dana-Farber Cancer Institute

  STUDY CHAIR

Central Study Contacts

Justin Alicea

CONTACT

434-243-5350; xzy7tw@virginia.edu

Katie Rea

CONTACT

434-924-8574; kaw3j@virginia.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the UVA Human Immune Therapy Center

Study Record Dates

• First Submitted: November 21, 2014
• First Posted: December 2, 2014
• Study Start: March 1, 2015
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 13, 2021

Record last verified: 2021-08

Locations

US (6)