Safety and Effectiveness of Nivolumab in Recurring Kidney... | NCT03568435

Studies
Safety and Effectiveness of Nivolumab in Recurring Kidney Cancer Participants

NCT03568435

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Oct 20, 2022Actual

Enrollment

212Actual

Phase

Not provided

Conditions

Kidney Cancer
Renal Cancer

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 2022

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

Feb 14, 2018Actual

Primary Completion Date

Dec 21, 2020Actual

Completion Date

Dec 21, 2020Actual

First Submitted Date

Jun 14, 2018

First Submission Date that Met QC Criteria

Jun 14, 2018

First Posted Date

Jun 26, 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

Oct 19, 2022

Last Update Posted Date

Oct 20, 2022Actual

Name	Class
Ono Pharma USA Inc	INDUSTRY

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

A non-interventional, medical record review of clinical data collected from Japanese participants with recurring kidney cancer

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

212Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participants with metastatic RCC taking nivolumab		Specified dose on specified day	Other: Non-Interventional

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-Interventional	Other	Non-Interventional	Participants with metastatic RCC taking nivolumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival status		6 months
Overall survival status		36 months
Best overall response		6 months
Best overall response		36 months
Progression free survival rate		6 months
Progression free survival rate		36 months
Disease free survival		6 months
Disease free survival		36 months
Objective response rate		6 months
Objective response rate		36 months
Duration of response		6 months
Duration of response		36 months

Secondary Outcomes

Measure	Description	Time Frame
Distribution of clinical characteristics		36 months
Distribution of socio-demographic characteristics		36 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A patient with RCC with distant metastasis treated for the first time with nivolumab

Exclusion Criteria:

Patients who have participated in some trials with immuno-checkpoint blockade before or after treatment with nivolumab after diagnosis with RCC

Other protocol defined inclusion/exclusion criteria could apply

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Participants with RCC with distant metastasis treated with nivolumab under real clinical practice

Sampling Method

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 - 0001		Tokyo		1070052	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
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms