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

NCT03161379 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: J1756IRB00130075
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• CD8+ T Cell Density in Tumor Tissue

  Mean CD8+ T cell density \[log(cells per mm\^2)\], found in resected surgical tissue by Immunohistochemistry (IHC).

  evaluated at time of surgery, approximately 2 months from first dose of study drug

Secondary Outcomes (1)

• Pathologic Complete Response (pCR) Rate at Surgical Resection

  Assessed at time of surgical resection, approximately 2 months after first dose of study drug

Study Arms (1)

CY, Nivolumab, GVAX, and SBRT

EXPERIMENTAL

CY, Nivolumab, GVAX, and SBRT

Drug: Cyclophosphamide; Drug: Nivolumab; Drug: GVAX Pancreas Vaccine; Radiation: Stereotactic Body Radiation (SBRT)

Interventions

Cyclophosphamide 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.

Also known as: CY

CY, Nivolumab, GVAX, and SBRT

Nivolumab 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.

Also known as: OPDIVO

CY, Nivolumab, GVAX, and SBRT

GVAX Pancreas Vaccine 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.

Also known as: PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1/GM-Neo vaccine

CY, Nivolumab, GVAX, and SBRT

Stereotactic Body Radiation (SBRT) 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).

CY, Nivolumab, GVAX, and SBRT

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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%

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Bristol-Myers Squibb: collaborator

Study Sites (2)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Cyclophosphamide; Nivolumab; Radiosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Daniel Laheru, MD
• Organization: Sidney Kimmel Cancer Center at Johns Hopkins

laherda@jhmi.edu

410-955-8974

Study Officials

• Daniel Laheru, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

• Arsen Osipov, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: May 19, 2017
• Study Start: February 2, 2018
• Primary Completion: February 20, 2024
• Study Completion: February 28, 2024
• Last Updated: February 3, 2025
• Results First Posted: February 3, 2025

Record last verified: 2025-01

Locations

US (2)