NCT03568435

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
212

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

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

February 14, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2020

Completed
Last Updated

October 20, 2022

Status Verified

October 1, 2022

Enrollment Period

2.9 years

First QC Date

June 14, 2018

Last Update Submit

October 19, 2022

Conditions

Kidney CancerRenal Cancer

Outcome Measures

Primary Outcomes (14)

  • 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

  • Incidence of adverse events

    36 months

  • Incidence of serious adverse events

    36 months

Secondary Outcomes (2)

  • Distribution of clinical characteristics

    36 months

  • Distribution of socio-demographic characteristics

    36 months

Study Arms (1)

Participants with metastatic RCC taking nivolumab

Specified dose on specified day

Other: Non-Interventional

Interventions

Non-InterventionalOTHER

Non-Interventional

Participants with metastatic RCC taking nivolumab

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution - 0001

Tokyo, 1070052, Japan

Location

Related Links

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital 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

June 14, 2018

First Posted

June 26, 2018

Study Start

February 14, 2018

Primary Completion

December 21, 2020

Study Completion

December 21, 2020

Last Updated

October 20, 2022

Record last verified: 2022-10

Locations

JP(1)