Study With CY, Pembrolizumab, GVAX Pancreas Vaccine, and SBRT in Patients With Locally Advanced Pancreatic Cancer

Phase 2

Completed

Conditions: Pancreatic Cancer

Interventions: Drug: Cyclophosphamide
Drug: GVAX Pancreatic Cancer Vaccine
Drug: Pembrolizumab
Radiation: SBRT

Registration Number: NCT02648282

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary: This study will be looking at whether combining cyclophosphamide, pembrolizumab (an antibody that blocks negative signals to T cells), GVAX (pancreatic cancer vaccine), and SBRT (focused radiation) is effective (anti-tumor activity) and safe in patients with locally advanced pancreatic cancer.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 58

Inclusion Criteria

Locally advanced pancreatic adenocarcinoma
Patients must have received mFOLFIRINOX or Gemcitabine/ Abraxane based chemotherapy for 4 cycles with last dose of therapy between 2-5 weeks of study enrollment.
Age >18 years
No metastatic disease
ECOG Performance Status of 0 to 1
Adequate organ function as defined by study-specified laboratory tests
Patients must be able to have fiducials placed for SBRT
Must use acceptable form of birth control through the study
Signed informed consent form
Willing and able to comply with study procedures

Exclusion Criteria

Patients who have been off of mFOLFIRINOX or gemcitabine/abraxane therapy for more than 49 days
Patients who have had more than one line of chemotherapy
Patients with uncontrolled intercurrent illness, including but not limited to ongoing or active infection, systematic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric condition that would limit compliance with study requirements
Patient who have had prior treatment with IL-2, interferon, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40, or anti-CTLA-4 antibodies
Patients receiving active immunosuppressive agents or chronic use of systemic corticosteroids within 14 days prior to first dose of study drug
Patients who have received growth factors, including but not limited to granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin, etc. within 14 days of study drug administration
Patients with history of any autoimmune disease:inflammatory bowel disease, (including ulcerative colitis and Crohn's Disease), rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematous (SLE) autoimmune vasculitis, CNS or motor neuropathy considered to be of autoimmune origin.
Patients who have known history of infection with HIV, hepatitis B, or hepatitis C
Patients with evidence of interstitial lung disease
Patients on home oxygen
Patients with oxygen saturation of <92% on room air by pulse oximetry
Pregnant or lactating
Conditions, including alcohol or drug dependence, or intercurrent illness that would affect the patient's ability to comply with study visits and procedures

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cyclophosphamide, Pembrolizumab, GVAX Pancreas Vaccine, SBRT	GVAX Pancreatic Cancer Vaccine	-
Cyclophosphamide, Pembrolizumab, GVAX Pancreas Vaccine, SBRT	SBRT	-
Cyclophosphamide, Pembrolizumab, GVAX Pancreas Vaccine, SBRT	Cyclophosphamide	-
Cyclophosphamide, Pembrolizumab, GVAX Pancreas Vaccine, SBRT	Pembrolizumab	-

Primary Outcome Measures

Name	Time	Method
Distant Metastasis Free Survival (DMFS)	62 months	DMFS is defined as the duration of time from start of treatment to identification of distant metastases on imaging or death, whichever occurs first. Estimation based on the Kaplan-Meier curve.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Experiencing a Grade 3 or Above Treatment Related Toxicities	41 months	When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v4.03) will be counted only once for a given subject.