Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Effectiveness of Nivolumab in Recurring Kidney Cancer Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03568435
Recruitment Status : Unknown
Verified July 2018 by Bristol-Myers Squibb.
Recruitment status was:  Active, not recruiting
First Posted : June 26, 2018
Last Update Posted : July 9, 2018
Sponsor:
Collaborator:
Ono Pharma USA Inc
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
A non-interventional, medical record review of clinical data collected from Japanese participants with recurring kidney cancer

Condition or disease Intervention/treatment
Kidney Cancer Renal Cancer Other: Non-Interventional

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Efficacy and Safety of Nivolumab in Metastatic Renal Cell Cancer Patients - Japanese Real-World Data Through Clinical Chart Review
Actual Study Start Date : February 14, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer
Drug Information available for: Nivolumab

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Participants with metastatic RCC taking nivolumab
Specified dose on specified day
 Other: Non-Interventional
Non-Interventional


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Overall survival status [ Time Frame: 6 months ]
  2. Overall survival status [ Time Frame: 36 months ]
  3. Best overall response [ Time Frame: 6 months ]
  4. Best overall response [ Time Frame: 36 months ]
  5. Progression free survival rate [ Time Frame: 6 months ]
  6. Progression free survival rate [ Time Frame: 36 months ]
  7. Disease free survival [ Time Frame: 6 months ]
  8. Disease free survival [ Time Frame: 36 months ]
  9. Objective response rate [ Time Frame: 6 months ]
  10. Objective response rate [ Time Frame: 36 months ]
  11. Duration of response [ Time Frame: 6 months ]
  12. Duration of response [ Time Frame: 36 months ]
  13. Incidence of adverse events [ Time Frame: 36 months ]
  14. Incidence of serious adverse events [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. Distribution of clinical characteristics [ Time Frame: 36 months ]
  2. Distribution of socio-demographic characteristics [ Time Frame: 36 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with RCC with distant metastasis treated with nivolumab under real clinical practice
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

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568435


Locations
Layout table for location information
Japan
Local Institution
Tokyo, Japan, 1070052
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharma USA Inc
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03568435    
Other Study ID Numbers: CA209-8D3
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: July 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type