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Durvalumab Long-Term Safety and Efficacy Study

NCT04078152 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2024-12-20

Study results available
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Summary

The aims of the study are to monitor the long-term safety of durvalumab, to provide continued treatment or retreatment with durvalumab to eligible patients, and to collect overall survival (OS) information.

Conditions

Interventions

DRUG

Durvalumab

IV infusion q4w with 1500mg durvalumab until progressive disease

Sponsors & Collaborators

  • Iqvia Pty Ltd

    collaborator INDUSTRY

  • Parexel

    collaborator INDUSTRY

  • Medidata Solutions

    collaborator INDUSTRY

  • CISCRP

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Jared Weiss, MD · University of North Carolina, Chapel Hill

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-09-05
Primary Completion
2022-10-31
Completion
2024-10-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • Czechia
  • France
  • Germany
  • Greece
  • Hungary
  • India
  • Israel
  • Japan
  • Malaysia
  • Netherlands
  • Poland
  • Romania
  • Russia
  • Serbia
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT04078152 on ClinicalTrials.gov