A Real-World Study of Ipilimumab Treatment After Nivoluma... | NCT03165422

Studies
A Real-World Study of Ipilimumab Treatment After Nivolumab Treatment in Melanoma in Japan

NCT03165422

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Oct 23, 2019Actual

Enrollment

68Actual

Phase

Not provided

Conditions

Melanoma

Interventions

Non-Interventional

Countries

Japan

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

Oct 2019

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

Mar 1, 2017Actual

Primary Completion Date

Dec 29, 2018Actual

Completion Date

Dec 29, 2018Actual

First Submitted Date

May 16, 2017

First Submission Date that Met QC Criteria

May 23, 2017

First Posted Date

May 24, 2017Actual

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

Oct 21, 2019

Last Update Posted Date

Oct 23, 2019Actual

Name	Class
Ono Pharmaceutical Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

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

68Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adult patients with melanoma		Adult patients with melanoma at participating centers in Japan	Other: Non-Interventional

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-Interventional	Other	Non-Interventional	Adult patients with melanoma

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of ipilimumab treatment after nivolumab treatment		Approximately 19 months
Incidence of nivolumab treatment after ipilimumab treatment		Approximately 19 months
Duration of nivolumab treatment		Approximately 19 months
Duration of ipilimumab treatment		Approximately 19 months
Duration of interval between nivolumab treatment and ipilimumab treatment		Approximately 19 months

Secondary Outcomes

Measure	Description	Time Frame
overall response rate (ORR)		Approximately 19 months
best overall response rate (BORR)		Approximately 19 months
overall survival (OS)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients > 18 years of age or older
Diagnosis of advanced melanoma (unresectable/metastatic), alive or deceased as of date of data collection
Treated with ipilimumab between 31-Aug-2015 and 31-Mar-2017 before or after nivolumab treatment

Exclusion Criteria:

Patients enrolled in any clinical trials at any time
Overlapping use of nivolumab and ipilimumab

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

Adult patients with melanoma who are patients at the participating centers in Japan will be enrolled.

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		Minato-ku	Tokyo	1050001	Japan

References Module

Citations

Not provided

Label	URL
BMS Clinical Trial Information	View source
Investigator Inquiry Form	View source
FDA Safety Alerts and Recalls

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