A Study of Nivolumab Plus Ipilimumab in Participants With Renal Cell Cancer in the Real World Setting in Japan
NCT ID: NCT04043975
Last Updated: 2025-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
286 participants
OBSERVATIONAL
2019-09-19
2024-08-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Effectiveness of Nivolumab in Recurring Kidney Cancer Participants
NCT03568435
A Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer
NCT03873402
A Study to Observe the Treatment Patterns and Outcomes of Patients in Japan With Kidney Cancer That is Unable to be Removed by Surgery or That Has Spread
NCT03161145
Non-Interventional Study (NIS) of Nivolumab With or Without Ipilimumab in Participants With Advanced Kidney Cancer
NCT03455452
A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
NCT03141177
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Pregnant and/or lactating women
* Participants who are judged to be inappropriate by investigator
20 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ono Pharmaceutical Co. Ltd
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Local Institution - 0001
Tokyo, , Japan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Nishimoto K, Kimura G, Sazuka T, Hamamoto S, Nozawa M, Numakura K, Mizokami A, Kondo T, Naito S, Abe T, Ohba K, Nagata M, Onodera S, Ito H, Uemura H. The Effectiveness and Safety Profile of Nivolumab-Plus-Ipilimumab in Previously Untreated Japanese Patients With Advanced or Metastatic Renal Cell Carcinoma (J-ENCORE Study). Int J Urol. 2025 Aug;32(8):961-972. doi: 10.1111/iju.70076. Epub 2025 Apr 24.
Related Links
Access external resources that provide additional context or updates about the study.
BMS Clinical Trial Information
Investigator Inquiry Form
FDA Safety Alerts and Recalls
BMS Clinical Trial Patient Recruiting
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CA209-7CR
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.