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

Advanced or Metastatic Renal Cell Carcinoma Clinical Trial

Official title:

Japanese Prospective Real World Registry of Nivolumab Plus Ipilimumab in Subjects With Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma (ARCC) Categorized Into IMDC Intermediate/Poor Risks (J-ENCORE)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04043975
• Other study ID #: CA209-7CR
• Status: Active, not recruiting
• Start date: September 19, 2019
• Est. completion date: August 23, 2024

Study information

• Verified date: May 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 286
• Est. completion date: August 23, 2024
• Est. primary completion date: August 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

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.

Related Conditions & MeSH terms

• Advanced or Metastatic Renal Cell Carcinoma
• Carcinoma
• Carcinoma, Renal Cell

Locations

Country	Name	City	State
Japan	Local Institution - 0001	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)		Up to 5 years
Secondary	Overall Survival (OS)		From date of starting nivolumab plus ipilimumab to the date of death from any cause. (Up to 5 years)
Secondary	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)
Secondary	Change in tumor response over time		Up to 5 years
Secondary	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)
Secondary	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
Secondary	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)
Secondary	ORR on subsequent therapy		From initiation of a second line of therapy after discontinuation of first line nivolumab+ipilimumab treatment (Up to 5 years)

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form