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GVAX Pancreas Vaccine (With CY) in Combination With Nivolumab and SBRT for Patients With Borderline Resectable Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Cyclophosphamide

Nivolumab

GVAX Pancreas Vaccine

Stereotactic Body Radiation (SBRT)

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Neoadjuvant therapy, immunotherapy, Cytoxan, Cyclophosphamide, Pancreatic Vaccine, SBRT, GVAX, Nivolumab, borderline resectable, Radioimmunotherapy, Vaccine, Antibody, Anti-PD-1

Eligibility Criteria

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

Inclusion Criteria:

Have histologically proven pancreatic cancer that is borderline resectable
No more than 1 month/cycle (28 days) of systemic therapy for pancreatic cancer
Age >18 years old.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
Woman of child bearing potential must have a negative pregnancy test.
Must use an acceptable form of birth control while on study.
Must be candidate for Stereotactic Body Radiation Therapy (SBRT)
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Had major surgery within the last 28 days
Had an investigational drug or device within the past 28 days
Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, etc)
Completed more than 1 month/cycle (28 days) of chemotherapy for pancreas cancer
Patient on an immunosuppressive systemic treatment, such as steroids, in the past 2 years.
Other cancer diagnosis requiring treatment within two years
History of allergic reactions related to the drugs (Nivolumab, Cyclophosphamide, GM-hetastarch, corn, dimethyl sulfoxide, fetal bovine serum, trypsin (porcine origin), yeast or any other component of the GVAX vaccine) in this study.
Patients receiving growth factors within the last 14 days.
Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, psychological, immune or other medical conditions.
Pregnant or breastfeeding.
Have known history of infection with HIV, hepatitis B, or hepatitis C.
Unwilling or unable to follow the study schedule for any reason.
Presence of tissue or organ allograft, regardless of need for immunosuppression (including corneal allograft)
Squamous pancreatic cancer or adenosquamous pancreatic cancer with malignant squamous cells >30%

Sites / Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Medical College of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CY, Nivolumab, GVAX, and SBRT

Arm Description

CY, Nivolumab, GVAX, and SBRT

Outcomes

Primary Outcome Measures

CD8 count (cells/mm^3) in the tumor microenvironment

Whether the CD8 count in the tumor microenvironment is higher for patients with BR-PDAC treated with neoadjuvant chemotherapy, SBRT, and Cy/GVAX/nivolumab immunotherapy as compared to archived samples from patients treated with FOLFIRINOX and SBRT.

Secondary Outcome Measures

Pathologic complete response (pCR) rate at surgical resection

Pathologic complete response (pCR) rate at surgical resection of BR-PDAC treated with neoadjuvant sequential chemotherapy, SBRT, and Cy/GVAX/nivolumab immunotherapy.

Full Information

NCT ID

NCT03161379

First Posted

May 18, 2017

Last Updated

September 6, 2023

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT03161379

Brief Title

GVAX Pancreas Vaccine (With CY) in Combination With Nivolumab and SBRT for Patients With Borderline Resectable Pancreatic Cancer

Official Title

A Phase II Clinical Trial of GVAX Pancreas Vaccine (With Cyclophosphamide) in Combination With Nivolumab and Stereotactic Body Radiation Therapy (SBRT) Followed by Definitive Resection for Patients With Borderline Resectable Pancreatic Adenocarcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 2, 2018 (Actual)

Primary Completion Date

September 2024 (Anticipated)

Study Completion Date

September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to evaluate the safety and clinical activity of FOLFIRINOX along with a whole cell vaccine with immune modulating doses of cyclophosphamide and nivolumab combined with Stereotactic Body Radiation Therapy (SBRT) in patients with pancreatic cancer.

6. Conditions and Keywords

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

Pancreatic Cancer

Keywords

Neoadjuvant therapy, immunotherapy, Cytoxan, Cyclophosphamide, Pancreatic Vaccine, SBRT, GVAX, Nivolumab, borderline resectable, Radioimmunotherapy, Vaccine, Antibody, Anti-PD-1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Masking Description

Open Label

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CY, Nivolumab, GVAX, and SBRT

Arm Type

Experimental

Arm Description

CY, Nivolumab, GVAX, and SBRT

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Other Intervention Name(s)

Intervention Description

Cyclophosphamide 200 mg/m2 will be administered one day prior to vaccination (day 0). First dose will be given within 4 to 6 weeks after chemotherapy. 3 weeks after the first dose of immunotherapy the second dose will be given.

Intervention Type

Drug

Intervention Name(s)

Nivolumab

Other Intervention Name(s)

OPDIVO

Intervention Description

Nivolumab (240 mg) will be administered one day prior to vaccination. First dose will be given within 4 to 6 weeks after chemotherapy. 3 weeks after the first dose of immunotherapy the second dose will be given.

Intervention Type

Drug

Intervention Name(s)

GVAX Pancreas Vaccine

Other Intervention Name(s)

PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1/GM-Neo vaccine

Intervention Description

Vaccine will be administered one day after cyclophosphamide and nivolumab. 3 weeks after the first dose of immunotherapy the second dose will be given.

Intervention Type

Radiation

Intervention Name(s)

Stereotactic Body Radiation (SBRT)

Intervention Description

SBRT (6.6 Gy over 5 days) will be started during the second dose of immunotherapy (3 weeks after the first dose of immunotherapy).

Primary Outcome Measure Information:

Title

CD8 count (cells/mm^3) in the tumor microenvironment

Description

Time Frame

4 years

Secondary Outcome Measure Information:

Title

Pathologic complete response (pCR) rate at surgical resection

Description

Pathologic complete response (pCR) rate at surgical resection of BR-PDAC treated with neoadjuvant sequential chemotherapy, SBRT, and Cy/GVAX/nivolumab immunotherapy.

Time Frame

4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have histologically proven pancreatic cancer that is borderline resectable No more than 1 month/cycle (28 days) of systemic therapy for pancreatic cancer Age >18 years old. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Patients must have adequate organ and marrow function defined by study-specified laboratory tests. Woman of child bearing potential must have a negative pregnancy test. Must use an acceptable form of birth control while on study. Must be candidate for Stereotactic Body Radiation Therapy (SBRT) Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Had major surgery within the last 28 days Had an investigational drug or device within the past 28 days Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, etc) Completed more than 1 month/cycle (28 days) of chemotherapy for pancreas cancer Patient on an immunosuppressive systemic treatment, such as steroids, in the past 2 years. Other cancer diagnosis requiring treatment within two years History of allergic reactions related to the drugs (Nivolumab, Cyclophosphamide, GM-hetastarch, corn, dimethyl sulfoxide, fetal bovine serum, trypsin (porcine origin), yeast or any other component of the GVAX vaccine) in this study. Patients receiving growth factors within the last 14 days. Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, psychological, immune or other medical conditions. Pregnant or breastfeeding. Have known history of infection with HIV, hepatitis B, or hepatitis C. Unwilling or unable to follow the study schedule for any reason. Presence of tissue or organ allograft, regardless of need for immunosuppression (including corneal allograft) Squamous pancreatic cancer or adenosquamous pancreatic cancer with malignant squamous cells >30%

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel Laheru, MD

Organizational Affiliation

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Arsen Osipov, MD

Organizational Affiliation

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21231

Country

United States

Facility Name

Medical College of Wisconsin

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

GVAX Pancreas Vaccine (With CY) in Combination With Nivolumab and SBRT for Patients With Borderline Resectable Pancreatic Cancer

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