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Immunotherapy Study for Surgically Resected Pancreatic Cancer

NCT01072981 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 722

Last updated 2020-05-28

No results posted yet for this study

Summary

The purpose of this study is to assess overall survival after treatment with a regimen of adjuvant therapy (Gemcitabine alone or with 5-FU chemoradiation) with or without HyperAcute®-Pancreas (algenpantucel-L) immunotherapy in subjects who have undergone surgical resection.

Conditions

Interventions

BIOLOGICAL

HyperAcute-Pancreas Immunotherapy

Up to 18 immunizations of 300 million immunotherapy cells

DRUG

Gemcitabine

Gemcitabine 1000 mg/m2/day once a week for 3 weeks

RADIATION

5FU Chemoradiation

5FU 200-250 mg/m2/day over 5 1/2 weeks with radiation.

Sponsors & Collaborators

  • NewLink Genetics Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT01072981 on ClinicalTrials.gov