NCT03504696

Brief Summary

This study will be conducted with the aim of estimating the effectiveness, safety, patterns of use of nivolumab, and characteristics of patients with unresectable or metastatic melanoma, treated with nivolumab monotherapy in the ATU setting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 20, 2018

Completed
Last Updated

April 27, 2018

Status Verified

April 1, 2018

Enrollment Period

1.2 years

First QC Date

February 22, 2018

Last Update Submit

April 25, 2018

Conditions

Melanoma

Outcome Measures

Primary Outcomes (4)

  • Overall survival (OS) at 1 year

    Overall survival (OS) for adult patients with advanced (unresectable or metastatic) melanoma treated with nivolumab in the ATU (Temporary Authorization for Use) program

    at 1 year

  • Distribution of demographic characteristics of patients with advanced melanoma treated with nivolumab monotherapy in the ATU program

    Distribution of demographic characteristics of patients with advanced melanoma treated with nivolumab monotherapy in the ATU program using descriptive statistics

    at baseline

  • Distribution of clinical characteristics in patients with advanced melanoma treated with nivolumab monotherapy

    Clinical characteristics will be summarized using descriptive statistics.

    at baseline

  • Overall survival (OS) at 2 years

    Overall survival (OS) for adult patients with advanced (unresectable or metastatic) melanoma treated with nivolumab in the ATU (Temporary Authorization for Use) program

    at 2 years

Secondary Outcomes (5)

  • Progression-free survival (PFS)

    1 year and 2 years

  • Objective response rate (ORR)

    1 year and 2 years

  • Progression-free survival (PFS) as assessed by RECIST 1.1

    at 1 year

  • Distribution of treatment patterns

    up to 2 years

  • Incidence of select Grade 3, 4, or 5 adverse events (AEs)

    up to 2 years

Study Arms (1)

Patients with Advanced Melanoma

RIC-Mel patients with advanced (unresectable or metastatic) melanoma treated with nivolumab in the context of nivolumab ATU program (occurred from 12-Sep-2014 to 31-Aug-2015)

Other: Non-interventional

Interventions

Non-interventionalOTHER

Non-interventional

Patients with Advanced Melanoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

RIC-Mel patients with advanced (unresectable or metastatic) melanoma treated with nivolumab in the context of nivolumab ATU program (occurred from 12-Sep-2014 to 31-Aug-2015).

You may qualify if:

  • Patients included in RIC-Mel Database:
  • Diagnosed with melanoma and cared for in the participating sites
  • Patients who have been given appropriate information about RIC-Mel Database aims and who have provided their written consent for data collection and processing before any data collection is carried out
  • Patients included in French nivolumab ATU program

You may not qualify if:

  • Patients included in RIC-Mel database having initiated nivolumab before 12-Sep-2014 or after 31-Aug-2015, or in the context of a clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Nantes, 44093, France

Location

Related Links

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2018

First Posted

April 20, 2018

Study Start

December 20, 2016

Primary Completion

February 20, 2018

Study Completion

February 20, 2018

Last Updated

April 27, 2018

Record last verified: 2018-04

Locations

FR(1)