NCT03438279

Brief Summary

This study will review published trial literature and documents for Overall Survival (OS) to evaluate the association between the hazard of death and each baseline variable.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Typical duration for all trials

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

June 23, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

2.5 years

First QC Date

January 31, 2018

Last Update Submit

February 16, 2018

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

  • Prognostic Model of Overall Survival (OS)

    The OS prognostic model uses Individual patient data from a pooled analysis of 12 ipilimumab studies.

    10 years

Study Arms (1)

First-Line Ipilimumab

patients who received ipilimumab as their first-line treatment

Other: Non-Interventional

Interventions

Non-InterventionalOTHER

Non-Interventional

First-Line Ipilimumab

Eligibility Criteria

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

Individual patient data (IPD) from the ipilimumab pooled analysis of clinical trials and observational studies will be used to construct the prognostic model for OS in advanced melanoma patients.

You may qualify if:

  • Diagnosis of melanoma

You may not qualify if:

  • Age less than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Boston, Massachusetts, 02199, United States

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

January 31, 2018

First Posted

February 19, 2018

Study Start

June 23, 2015

Primary Completion

December 28, 2017

Study Completion

December 28, 2017

Last Updated

February 19, 2018

Record last verified: 2018-02

Locations

US(1)