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

May 25, 2022 updated by: Bristol-Myers Squibb

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

286

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan, 1070052
        • Local Institution - 0001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort 1
Participants with advanced or metastatic renal cell carcinoma (aRCC) receiving the combination of nivolumab plus ipilimumab as the first line of systemic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to 5 years
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: From date of starting nivolumab plus ipilimumab to the date of death from any cause. (Up to 5 years)
From date of starting nivolumab plus ipilimumab to the date of death from any cause. (Up to 5 years)
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator
Time Frame: 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)
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)
Change in tumor response over time
Time Frame: Up to 5 years
Up to 5 years
Duration of Response (DOR)
Time Frame: 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)
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
Time Frame: Up to 6 months
Up to 6 months
Number of participants with Adverse Events (AEs)
Time Frame: During the observation period or until 100 days after discontinuation of dosing with nivolumab and ipilimumab (Up to 5 years)
During the observation period or until 100 days after discontinuation of dosing with nivolumab and ipilimumab (Up to 5 years)
ORR on subsequent therapy
Time Frame: From initiation of a second line of therapy after discontinuation of first line nivolumab+ipilimumab treatment (Up to 5 years)
From initiation of a second line of therapy after discontinuation of first line nivolumab+ipilimumab treatment (Up to 5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

Ono Pharmaceutical Co. Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 19, 2019

Primary Completion (ANTICIPATED)

August 23, 2024

Study Completion (ANTICIPATED)

August 23, 2024

Study Registration Dates

First Submitted

July 31, 2019

First Submitted That Met QC Criteria

August 1, 2019

First Posted (ACTUAL)

August 2, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 27, 2022

Last Update Submitted That Met QC Criteria

May 25, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-7CR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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