An observational study in Advanced or Metastatic Renal Cell Carcinoma, sponsored by Bristol-Myers Squibb. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-02-14.
Sponsored by Bristol-Myers Squibb · Observational
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 286 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.
Browse Carcinoma studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply.
Participants with advanced or metastatic renal cell carcinoma (aRCC) receiving the combination of nivolumab plus ipilimumab as the first line of systemic therapy
Objective Response Rate (ORR)
Time frame: Up to 5 years
Overall Survival (OS)
Time frame: 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)
Change in tumor response over time
Time frame: 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)
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
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)
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)
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bristol-Myers Squibb