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

Primary Purpose

Pancreatic Cancer

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Pembrolizumab

Neoadjuvant Chemoradiation

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Immunotherapy, Neoadjuvant, Resectable, Borderline resectable

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mayo Clinic Cancer CenterRecruiting
Hartford HealthCareRecruiting
University of Miami
Dana-Farber Cancer InstituteRecruiting
MD AndersonRecruiting
University of Virginia Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neodjuvant CRT + Pembrolizumab

Neoadjuvant CRT

Arm Description

Standard neoadjuvant chemoradiation treatment (CRT) with pembrolizumab

Standard neoadjuvant chemoradiation treatment (CRT) alone

Outcomes

Primary Outcome Measures

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

Safety: Incidence of Dose-Limiting Toxicities (DLTs)

Secondary Outcome Measures

Disease-free survival (DFS)

Overall survival (OS)

Response Rate (RR)

Full Information

NCT ID

NCT02305186

First Posted

November 21, 2014

Last Updated

August 11, 2021

Sponsor

Craig L Slingluff, Jr

1. Study Identification

Unique Protocol Identification Number

NCT02305186

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

March 2015 (undefined)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Craig L Slingluff, Jr

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

Keywords

Immunotherapy, Neoadjuvant, Resectable, Borderline resectable

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Neodjuvant CRT + Pembrolizumab

Arm Type

Experimental

Arm Description

Standard neoadjuvant chemoradiation treatment (CRT) with pembrolizumab

Arm Title

Neoadjuvant CRT

Arm Type

Active Comparator

Arm Description

Standard neoadjuvant chemoradiation treatment (CRT) alone

Intervention Type

Drug

Intervention Name(s)

Pembrolizumab

Other Intervention Name(s)

MK-3475, Keytruda

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

Neoadjuvant Chemoradiation

Intervention Description

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 Information:

Title

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

Time Frame

2-3 years

Title

Safety: Incidence of Dose-Limiting Toxicities (DLTs)

Time Frame

2-3 years

Secondary Outcome Measure Information:

Title

Disease-free survival (DFS)

Time Frame

2-4 years

Title

Overall survival (OS)

Time Frame

2-4 years

Title

Response Rate (RR)

Time Frame

2-3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Justin Alicea

Phone

434-243-5350

xzy7tw@virginia.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Katie Rea

Phone

434-924-8574

kaw3j@virginia.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Osama Rahma, MD

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Study Chair

Facility Information:

Facility Name

Mayo Clinic Cancer Center

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85054

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Justin Weber

Phone

855-776-0015

weber.justin@mayo.edu

First Name & Middle Initial & Last Name & Degree

Chee-Chee Stucky, MD

Facility Name

Hartford HealthCare

City

Hartford

State/Province

Connecticut

ZIP/Postal Code

06102

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Leah Persky

leah.persky@hhchealth.org

First Name & Middle Initial & Last Name & Degree

Rawad Elias, MD

Facility Name

University of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Individual Site Status

Completed

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Katherine Metayer

Phone

617-632-6316

KatherineA_Metayer@DFCI.HARVARD.EDU

First Name & Middle Initial & Last Name & Degree

Osama Rahma, MD

OsamaE_Rahma@DFCI.HARVARD.EDU

First Name & Middle Initial & Last Name & Degree

Osama Rahma, MD

Facility Name

MD Anderson

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Edsel Esquivel

EFEsquivel@mdanderson.org

First Name & Middle Initial & Last Name & Degree

Matthew Katz, MD

First Name & Middle Initial & Last Name & Degree

Gauri Varadhachary, MD

Facility Name

University of Virginia Cancer Center

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Adela Mahmutovic

am6bd@hscmail.mcc.virginia.edu

First Name & Middle Initial & Last Name & Degree

Todd Bauer, MD

12. IPD Sharing Statement

Learn more about this trial

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

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