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OpenTrials
Completed

NCT Number: NCT03568435

Safety and Effectiveness of Nivolumab in Recurring Kidney Cancer Participants

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

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Key information

Conditions

Kidney Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Renal Cancer Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution - 0001

Tokyo, 1070052, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional

Other

Non-Interventional

Primary outcomes

  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 outcomes

  1. Distribution of clinical characteristics

    Time frame: 36 months

  2. Distribution of socio-demographic characteristics

    Time frame: 36 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Ono Pharma USA Inc

Registry information

Official study title

Efficacy and Safety of Nivolumab in Metastatic Renal Cell Cancer Patients - Japanese Real-World Data Through Clinical Chart Review

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 26, 2018
Registry last updated
Oct 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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