Last reviewed · How we verify

NCT03325257: Post-ATU

Post-ATU Study of Nivolumab

Completed Last updated 14 September 2021
What this trial tests

trial testing Routine care in Melanoma in 350 participants. Completed in 1 March 2019.

Timeline
9 March 2017
Primary endpoint
6 September 2018
1 March 2019

Quick facts

Lead sponsorNantes University Hospital
StatusCompleted
Study typeOBSERVATIONAL
Enrollment350
Start date9 March 2017
Primary completion6 September 2018
Estimated completion1 March 2019
Sites17 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

Nantes University Hospital

Who can join

18 and older, any sex, with Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Routine care

Trials testing the same drug.

Other recruiting trials for Melanoma

Currently open trials in the same condition.

Other Nantes University Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03325257.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing