Survival Study for Participants Treated With Ipilimumab-N... | NCT03438279

Studies
Survival Study for Participants Treated With Ipilimumab-Nivolumab Combination Therapy

NCT03438279

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Feb 19, 2018Actual

Enrollment

600Actual

Phase

Not provided

Conditions

Melanoma

Interventions

Non-Interventional

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 23, 2015Actual

Primary Completion Date

Dec 28, 2017Actual

Completion Date

Dec 28, 2017Actual

First Submitted Date

Jan 31, 2018

First Submission Date that Met QC Criteria

Feb 16, 2018

First Posted Date

Feb 19, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2018

Last Update Posted Date

Feb 19, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
First-Line Ipilimumab		patients who received ipilimumab as their first-line treatment	Other: Non-Interventional

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-Interventional	Other	Non-Interventional	First-Line Ipilimumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prognostic Model of Overall Survival (OS)	The OS prognostic model uses Individual patient data from a pooled analysis of 12 ipilimumab studies.	10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of melanoma

Exclusion Criteria:

Age less than 18 years old

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution		Boston	Massachusetts	02199	United States

Condition Browse Module

MeSH Terms

ID	Term
D008545	Melanoma

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided