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

NCT03344172 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2020-05-14

Study results available
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Summary

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.

Conditions

  • Pancreatic Cancer Resectable

Interventions

DRUG

Gemcitabine, Nab-Paclitaxel, hydroxychloroquine and Avelumab

Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m\^2) and nab-paclitaxel (125mg/m\^2) Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery Day 1 of Cycle 3: avelumab (10mg/kg)

DRUG

Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine

Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m\^2) and nab-paclitaxel (125mg/m\^2) Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • Nathan Bahary, MD

    lead OTHER

Principal Investigators

  • Nathan Bahary, MD · UPMC Hillman Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-13
Primary Completion
2019-04-30
Completion
2019-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03344172 on ClinicalTrials.gov