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Safety and Effectiveness of Nivolumab in Recurring Kidney Cancer Participants

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03568435
Enrollment
212
Registered
2018-06-26
Start date
2018-02-14
Completion date
2020-12-21
Last updated
2022-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Cancer, Renal Cancer

Brief summary

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

Interventions

OTHERNon-Interventional

Non-Interventional

Sponsors

Ono Pharma USA Inc
CollaboratorINDUSTRY
Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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/

Design outcomes

Primary

MeasureTime frame
Incidence of serious adverse events36 months
Duration of response6 months
Incidence of adverse events36 months
Overall survival status6 months
Best overall response6 months
Progression free survival rate6 months
Disease free survival6 months
Objective response rate6 months

Secondary

MeasureTime frame
Distribution of socio-demographic characteristics36 months
Distribution of clinical characteristics36 months

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026