Skip to main content
OpenTrials
Completed

NCT Number: NCT04043975

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Advanced or Metastatic Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution - 0001

Tokyo, 1070052, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Objective Response Rate (ORR)

    Time frame: Up to 5 years

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: From date of starting nivolumab plus ipilimumab to the date of death from any cause. (Up to 5 years)

  2. 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)

  3. Change in tumor response over time

    Time frame: Up to 5 years

  4. 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)

  5. 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

  6. 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)

  7. 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)

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Ono Pharmaceutical Co., Ltd.

Registry information

Official study 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)

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Aug 2, 2019
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.