Clinical trial NCT04043975: A Study of Nivolumab Plus Ipilimumab in Participants With Renal Cell Cancer in the Real World Setting in Japan
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced or Metastatic Renal Cell Carcinoma
Keywords: Japanese
Observational Study
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2019-08-02
Enrollment: 286
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of Japanese participants who will be treated with the combination of nivolumab+ipilimumab as first line of systematic therapy in the real world setting.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to 5 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From date of starting nivolumab plus ipilimumab to the date of death from any cause. (Up to 5 years)
measure: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator
timeFrame: 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)
measure: Change in tumor response over time
timeFrame: Up to 5 years
measure: Duration of Response (DOR)
timeFrame: 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)
measure: 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
timeFrame: Up to 6 months
measure: Number of participants with Adverse Events (AEs)
timeFrame: During the observation period or until 100 days after discontinuation of dosing with nivolumab and ipilimumab (Up to 5 years)
measure: ORR on subsequent therapy
timeFrame: From initiation of a second line of therapy after discontinuation of first line nivolumab+ipilimumab treatment (Up to 5 years)
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Local Institution - 0001
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: