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GVAX Pancreas Vaccine (With CY) and CRS-207 With or Without Nivolumab

NCT02243371 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2021-04-06

Study results available
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Summary

The primary objective of this study is to compare the overall survival (OS) of subjects with previously treated metastatic pancreatic cancer treated with cyclophosphamide (CY)/nivolumab/GVAX pancreas vaccine followed by nivolumab/CRS-207 (Arm A) to subjects treated with CY/GVAX pancreas vaccine followed by CRS-207 (Arm B).

Conditions

  • Previously Treated Metastatic Adenocarcinoma of the Pancreas

Interventions

BIOLOGICAL

CRS-207

1 × 10\^9 CFU administered IV on Day 2 of Cycles 3-6

BIOLOGICAL

CRS-207

1 × 10\^9 CFU administered IV on Day 1 of Cycles 3-6

DRUG

nivolumab

3 mg/kg administered IV on Day 1 of Cycles 1-6

BIOLOGICAL

GVAX

5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2

DRUG

CY

200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2

Sponsors & Collaborators

Principal Investigators

  • Dung Le, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-02
Primary Completion
2017-07-21
Completion
2017-07-21

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT02243371 on ClinicalTrials.gov