NCT04043975Completed
A Study of Nivolumab Plus Ipilimumab in Participants With Renal Cell Cancer in the Real World Setting in Japan
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)
Source: ClinicalTrials.gov · Last updated 14 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 286 (actual)
- First submitted
- 31 Jul 2019
- Start date
- 19 Sept 2019
- Primary completion date
- 23 Aug 2024
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Kidney cancer
- NCT number
- NCT04043975
What you commit to
- Study type: Observational
- Participants enrolled: 286
- From 19 Sept 2019 to the primary completion date, 23 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who are enrolled in a post marketing safety study on nivolumab plus ipilimumab combination therapy in Japan
Other
- Pregnant and/or lactating women
- Participants who are judged to be inappropriate by investigator
- Other protocol-defined inclusion/exclusion criteria apply.
Who the study is looking for
- 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
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
Related publications
- A Minimum 3-Year Follow-Up of Nivolumab-Plus-Ipilimumab in Japanese Patients With Advanced or Metastatic Renal Cell Carcinoma: A Final Analysis of the J-ENCORE Study.Int J Urol · 2026 · PMID 41841331
- Outcomes of Nivolumab-Plus-Ipilimumab in Metastatic Renal Cell Carcinoma: Second Interim Analysis of the J-ENCORE Study.Int J Urol · 2026 · PMID 41292059
This page is information, not medical advice. Discuss any trial with your doctor.