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Post-ATU Study of Nivolumab

NCT03325257 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 350

Last updated 2021-09-14

No results posted yet for this study

Summary

Nivolumab obtained European Marketing authorization in June 2015. Before this date, a Temporary Authorization for Use (ATU) Program in France for nivolumab was set up between September 2014 and August 2015. This program enrolled approximately 600 melanoma patients (unresectable or metastatic).

It appears relevant to conduct a study on patients treated during the ATU to assess thoroughly patient characteristics, efficacy, safety, and patterns of use of nivolumab in real-life conditions.

Conditions

Interventions

OTHER

Routine care

This study is an observational one - there is no change to the routine care. Patients received the Nivolumab independently of the study. Only data will be collected during this project.

Sponsors & Collaborators

Principal Investigators

  • Brigitte DRENO, PU-PH · Nantes University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-09
Primary Completion
2018-09-06
Completion
2019-03-01

Countries

  • France

Study Locations

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Entities

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 NCT03325257 on ClinicalTrials.gov