A Study of Nivolumab Plus Ipilimumab in Participants With Renal Cell Cancer in the Real World Setting in Japan

• Conditions: Advanced or Metastatic Renal Cell Carcinoma

• Registration Number: NCT04043975
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of the observational study is to evaluate the safety and effectiveness of combination therapy with nivolumab and ipilimumab in Japanese participants with advanced or metastatic renal cell carcinoma (aRCC) in the real-world setting in Japan.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-07-31
• Study First Submitted QC: 2019-08-01
• Study First Posted: 2019-08-02
• Study Start: 2019-09-19
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-25
• Last Update Posted: 2022-05-27
• Primary Completion: 2024-08-23
• Study Completion: 2024-08-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 286

Inclusion Criteria

• Histological confirmation of Renal Cell Carcinoma (RCC)
• No prior systemic therapy for RCC
• Participants who are planned to start treatment with nivolumab and ipilimumab regimen in the timeframe between after IRB approval to enrollment-end date
• International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk category Intermediate/Poor

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Exclusion Criteria

• Participants who are enrolled in a post marketing safety study on nivolumab plus ipilimumab combination therapy in Japan
• Pregnant and/or lactating women
• Participants who are judged to be inappropriate by investigator

Other protocol-defined inclusion/exclusion criteria apply.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	Up to 5 years

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	From date of starting nivolumab plus ipilimumab to the date of death from any cause. (Up to 5 years)
Duration of Response (DOR)	From first documentation of tumor response after the date of starting nivolumab plus ipilimumab to disease progression or death due to any cause, whichever occurs first. (Up to 5 years)
The quality of life by National Comprehensive Cancer Network/ Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) v2.0	Up to 6 months
ORR on subsequent therapy	From initiation of a second line of therapy after discontinuation of first line nivolumab+ipilimumab treatment (Up to 5 years)
Change in tumor response over time	Up to 5 years
Number of participants with Adverse Events (AEs)	During the observation period or until 100 days after discontinuation of dosing with nivolumab and ipilimumab (Up to 5 years)
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator	From date of starting nivolumab plus ipilimumab to the first date of documented progression, as determined by the investigators (as per RECIST 1.1 criteria), or death due to any cause, whichever occurs first. (Up to 5 years)

Trial Locations

Locations (1)

Local Institution - 0001; 🇯🇵 Tokyo, Japan