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

NCT02648282 | Completed Phase 2 Results DMC

• 2 other identifiers: J15237IRB00083132
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

vaccine; immunotherapy; antibody; PD-1; radiation

Outcome Measures

Primary Outcomes (1)

• Distant Metastasis Free Survival (DMFS)

  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.

  62 months

Secondary Outcomes (1)

• Number of Participants Experiencing a Grade 3 or Above Treatment Related Toxicities

  41 months

Study Arms (1)

Cyclophosphamide, Pembrolizumab, GVAX Pancreas Vaccine, SBRT

EXPERIMENTAL

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

Interventions

Pembrolizumab DRUG

200 mg will be administered as a 30 minute IV infusion one day prior to the GVAX pancreas vaccine every 21 days for a total of 8 doses. In the extended treatment phase, eligible patients may receive 200 mg as a 30 minute IV infusion every 21 days for an additional 9 doses.

Also known as: MK-3475, KEYTRUDA

Cyclophosphamide, Pembrolizumab, GVAX Pancreas Vaccine, SBRT

Cyclophosphamide DRUG

200 mg/m2 is to be administered as a 30 minute IV infusion one day prior to GVAX Pancreas Vaccine every 21 days for a total of 8 doses. In the extended treatment phase, eligible patients may receive 200 mg/m2 as a 30 minute IV infusion one day prior to GVAX Pancreas Vaccine every 6 months for an additional 4 doses.

Also known as: Cytoxan, CY

Cyclophosphamide, Pembrolizumab, GVAX Pancreas Vaccine, SBRT

SBRT RADIATION

Patients will receive SBRT (6.6 Gy for 5 days) with the second dose of combined immunotherapy (CY/Pembrolizumab/GVAX Pancreas Vaccine).

Also known as: Stereotactic Body Radiation Therapy

Cyclophosphamide, Pembrolizumab, GVAX Pancreas Vaccine, SBRT

GVAX Pancreatic Cancer Vaccine DRUG

2.5E8 cells of each cell line (Panc 6.03/Panc 10.05) for a total of 5E8 cells is to be administered one day after CY and pembrolizumab for a total of 8 doses. In the extended treatment phase, eligible patients may receive 2.5E8 cells of each cell line (Panc 6.03/Panc 10.05) for a total of 5E8 cells administered one day after CY every 6 months for an additional 4 doses.

Also known as: Pancreas cancer vaccine, Panc 10.05 pcDNA1/GM-Neo, Panc 6.03 pcDNA1/GM-Neo

Cyclophosphamide, Pembrolizumab, GVAX Pancreas Vaccine, SBRT

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: collaborator
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

The Sidney Kimmel Comprehensive Cancer at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Cyclophosphamide; pembrolizumab; 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; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Valerie Lee MD
• Organization: Sidney Kimmel Cancer Center at Johns Hopkins

vlee32@jhmi.edu

443-287-6825

Study Officials

• Valerie Lee, 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
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: January 7, 2016
• Study Start: July 18, 2016
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: March 13, 2026
• Results First Posted: February 28, 2023

Record last verified: 2026-02

Locations

US (1)