Pre-Operative Trial (PGHA vs. PGH) for Resectable Pancreatic Cancer



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:12/22/2018
Start Date:December 13, 2017
End Date:January 1, 2021
Contact:Daniel Goldstein, BSN
Email:goldsteindj@upmc.edu
Phone:412-864-7820

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Randomized Phase II Trial of Pre-Operative Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine With or Without Avelumab (PGHA vs. PGH)

This is a randomized phase II trial that will examine the ability of Avelumab to improve the
clinical activity of a pre-operative regimen of gemcitabine, nab-paclitaxel and
hydroxychloroquine in subjects with potentially resectable adenocarcinoma of the pancreas.


Inclusion Criteria:

- Has biopsy-proven adenocarcinoma of the pancreas that is determined to be potentially
or borderline resectable by National Comprehensive Cancer Network (NCCN) criteria.

- Karnofsky performance status of 70-100%.

- No active second malignancy with the exception of basal or squamous cell carcinoma of
the skin.

- Has adequate biological parameters as demonstrated by blood counts at screening
(obtained ≤14 days prior to randomization).

- Has adequate blood chemistry levels at Baseline visit. -Age >18 years.

- Must be able to swallow enteral medications with no requirement for a feeding tube.

Exclusion Criteria:

- Deemed surgically unresectable or unwilling to undergo surgical resection.

- Prior use of chemotherapy, radiotherapy, and / or investigational agents for
pancreatic cancer.

- Any evidence of metastasis to distant organs (liver, lung, peritoneum).

- Symptomatic evidence of gastric outlet obstruction.

- Inability to adhere to study and/or follow-up procedures.

- History of allergic reactions or hypersensitivity to the study drugs.

- Known or suspected HIV infection Active or history of autoimmune disease or immune
deficiency.

- Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with
dermatologic manifestations.

- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis
obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of
active pneumonitis on screening chest computed tomography scan.

- Patient with a history of interstitial lung disease, history of slowly progressive
dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis
or pulmonary hypersensitivity pneumonitis.

- Active hepatitis B virus (HBV) infection (chronic or acute), defined as having a
positive hepatitis B surface antigen (HBsAg) test at screening.

- Known clinically significant liver disease Active tuberculosis Severe infection within
4 weeks prior to initiation of study treatment Significant cardiovascular disease
Grade >/= 3 hemorrhage or bleeding event within 28 days prior to initiation of study
treatment.

- Prior allogeneic stem cell or organ transplantation including corneal transplant

- Major surgical procedure other than for diagnosis within 4 weeks prior to initiation
of study treatment.

- Any other disease, metabolic dysfunction, physical examination finding, or clinical
laboratory finding that contraindicates the use of an investigational drug.

- Pregnant or breastfeeding, or intending to become pregnant during the study

- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study
treatment.

- History of severe allergic anaphylactic reactions to chimeric or humanized antibodies
or fusion proteins Known hypersensitivity to Chinese hamster ovary cell products or
recombinant human antibodies Known allergy or hypersensitivity to any of the study
drugs or any of their excipients.

- Treatment with systemic immunosuppressive medication Patients requiring the use of
enzyme-inducing anti-epileptic medication Patients with previously documented macular
degeneration or diabetic retinopathy are excluded.

- Subjects with ventricular pacemaker Patients on Coumadin must be willing to switch to
an alternative subcutaneous Low-molecular-weight heparin (LMWH) or oral agent.

- Must not have intractable nausea or vomiting which prohibits the patient from oral
medications Ability to understand and the willingness to sign a written informed
consent document.
We found this trial at
1
site
Pittsburgh, Pennsylvania 15232
Principal Investigator: Nathan Bahary, MD, PhD
Phone: 412-864-7820
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mi
from
Pittsburgh, PA
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