Clinical trial NCT03161379: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: Neoadjuvant therapy
immunotherapy
Cytoxan
Cyclophosphamide
Pancreatic Vaccine
SBRT
GVAX
Nivolumab
borderline resectable
Radioimmunotherapy
Vaccine
Antibody
Anti-PD-1
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2017-05-19
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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%

Primary outcomes:
measure: CD8+ T Cell Density in Tumor Tissue
timeFrame: evaluated at time of surgery, approximately 2 months from first dose of study drug
Secondary outcomes:
measure: Pathologic Complete Response (pCR) Rate at Surgical Resection
timeFrame: Assessed at time of surgical resection, approximately 2 months after first dose of study drug
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Daniel Laheru, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Arsen Osipov, MD
role: PRINCIPAL_INVESTIGATOR
References: