- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03153410
Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas
A Pilot Study of a GVAX Pancreas Vaccine (With Cyclophosphamide) in Combination With a PD-1 Blockade Antibody (Pembrolizumab) and a Macrophage Targeting Agent (CSF1R Inhibitor) for the Treatment of Patients With Borderline Resectable Adenocarcinoma of the Pancreas
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21231
- Sidney Kimmel Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Have histologically or cytologically proven adenocarcinoma of the pancreas.
- Patient's acceptance to have a core biopsy.
- Presence of at least one measurable lesion.
- Must not have metastatic disease.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan. See Section 10.1.2 for the evaluation of measurable disease.
- Must have received last dose of stereotactic body radiotherapy no longer than 28 days prior to enrollment.
- Must have received last dose of chemotherapy at least 14 days or longer prior to entry into the study.
- Age >18 years.
- ECOG performance status 0-1.
- Patient's blood, kidney and liver function must within normal limits
- Must use an acceptable form of birth control while on study.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Currently is participating or has participated in a study using any investigational therapy within the past 28 days or is currently using an investigational device.
- Major surgery 28 days prior to study entry excluding minor procedures (dental work, skin biopsy, etc.), celiac plexus block, and biliary stent placement.
- Used any systemic steroids, immunosuppressant medications and anti-neoplastic treatment in the past 14 days.
- Prior treatment with immunotherapy agents (including, but not limited to: IL-2, interferon, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40, or anti-CTLA-4 antibodies).
- Used any growth factors including, but not limited to, granulocyte-colony stimulating factor (G-CSF), GM-CSF, erythropoietin, within 14 days of study drug administration. Use of such agents while on study is also prohibited.
- Received any prophylactic vaccine within 14 days of first dose of study drug or received a live vaccine within 30 days of study treatment.
- Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, psychological, immune or other medical conditions.
- History of any autoimmune disease: inflammatory bowel disease, (including ulcerative colitis and Crohn's Disease), rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus (SLE) autoimmune vasculitis (e.g., Wegener's Granulomatosis), CNS or motor neuropathy considered to be of autoimmune origin (e.g., Guillian-Barre Syndrome, Myasthenia Gravis, Multiple Sclerosis). Patients with thyroid disease will be allowed.
- Has history of (non-infectious) pneumonitis that required steroids, history or evidence of interstitial lung disease or active, non-infectious pneumonitis.
- Has a pulse oximetry < 92% on room air.
- Evidence of ascites on imaging.
- Requires the use of home oxygen.
- Have known history of infection with HIV, hepatitis B, or hepatitis C.
- Have been diagnosed with another cancer in the past 5 years (except for superficial bladder cancer, non-melanoma skin cancers, or a low grade prostate cancer not requiring therapy)
- History of severe hypersensitivity reaction to any monoclonal antibody.
- Known or suspected hypersensitivity to GM-CSF, hetastarch, corn, dimethyl sulfoxide, fetal bovine serum, trypsin (porcine origin), yeast or any other component of GVAX pancreas vaccine.
- Pregnant or breastfeeding women.
- Positive pregnancy test during the study.
- Women sexually active with a fertile man and of childbearing potential unwilling or unable to use an acceptable method to avoid pregnancy for the entire study and for up to 120 days after the last dose of study drug.
- Unwilling or unable to follow the study schedule for any reason.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cyclophosphamide, GVAX, Pembrolizumab and IMC-CS4
|
200 mg/m2 is to be administered as a 30 minute IV infusion one day prior to GVAX for a total of 8 doses. Other Names: Cytoxan CY
Other Names:
5E8 cells is to be administered one day after CY, pembrolizumab, and IMC-CS4/ LY3022855 for a total of eight doses. Other Names: Pancreatic cancer vaccine Panc 10.05 pcDNA1/GM-Neo, Panc 6.03 pcDNA1/GM-Neo
Other Names:
200 mg will be administered as a 30 minute IV infusion one day prior to the GVAX pancreas vaccine for a total of 18 doses. Other Names: MK-3475 KEYTRUDA
Other Names:
75 mg for dose level 1 and 100 mg at dose level 2 will be administered (Day 1, Day 8 and Day 15) as a 30 minute(s) IV infusion one day prior to GVAX pancreas vaccine for a total 18 doses.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
CD8 T cell density in the primary tumor after neoadjuvant administration of combination immunotherapy by immunohistochemistry (IHC)
Time Frame: 2 years
|
2 years
|
Number of participants experiencing study drug-related toxicities
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression free survival (PFS)
Time Frame: 2 years
|
2 years
|
Overall survival (OS)
Time Frame: 2 years
|
2 years
|
Disease free survival (DFS)
Time Frame: 2 years
|
2 years
|
Objective response rate (ORR) by immune-related RECIST criteria (irRC)
Time Frame: 2 years
|
2 years
|
Surgical resectability rate of borderline resectable pancreatic cancer (BRPC)
Time Frame: 2 years
|
2 years
|
Pathologic response rate of patients with BRPC
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ana DeJesus, MD, Johns Hopkins University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Cyclophosphamide
- Pembrolizumab
Other Study ID Numbers
- J1766
- IRB00130267 (Other Identifier: JHMIRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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