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Study Evaluating NEOadjuvant Immunotherapy in Resectable PANCreatic Ductal Adenocarcinoma

NCT03979066 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2020-12-23

Study results available
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Summary

The purpose of this study is to determine if study treatment with atezolizumab and PEGPH20 given before and after surgery, followed by chemotherapy is safe and if it can further increase the immune response against the tumor rather than increase the chance of cure.

Conditions

Interventions

DRUG

Atezolizumab

840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.

DRUG

PEGPH20

PEGPH20 3ug/kg IV twice weekly for 3 weeks prior to surgery and once weekly for 3 weeks (of 28 day cycle) for two cycles after surgery.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Halozyme Therapeutics

    collaborator INDUSTRY

  • Gulam Manji

    lead OTHER

Principal Investigators

  • Gulam Manji, MD, PhD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2019-11-03
Completion
2019-11-03
FDA Drug
Yes

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 NCT03979066 on ClinicalTrials.gov