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

NCT ID: NCT03161379

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-02
• Study Completion Date: 2024-02-28

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CY, Nivolumab, GVAX, and SBRT

CY, Nivolumab, GVAX, and SBRT

Group Type: EXPERIMENTAL

Cyclophosphamide

Intervention Type: DRUG

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.

Nivolumab

Intervention Type: DRUG

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.

GVAX Pancreas Vaccine

Intervention Type: DRUG

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

Stereotactic Body Radiation (SBRT)

Intervention Type: RADIATION

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

Interventions

Cyclophosphamide

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

Nivolumab

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

GVAX Pancreas Vaccine

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: DRUG

Stereotactic Body Radiation (SBRT)

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

Intervention Type: RADIATION

Other Intervention Names

CY; OPDIVO; PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1/GM-Neo vaccine

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%

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Laheru, MD

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Arsen Osipov, MD

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00130075

Identifier Type: OTHER

Identifier Source: secondary_id

J1756

Identifier Type: -

Identifier Source: org_study_id