Status:
ACTIVE_NOT_RECRUITING
Non-Interventional Study (NIS) of Nivolumab With or Without Ipilimumab in Participants With Advanced Kidney Cancer
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Renal Cell Carcinoma
Renal Cell Cancer
Eligibility:
All Genders
18+ years
Brief Summary
This is a French, nationwide, prospective, observational, multi-center study in participants diagnosed with advanced renal cell carcinoma, who start a new systemic therapy with nivolumab with or witho...
Eligibility Criteria
Inclusion
- Adult participants with the diagnosis of advanced renal cell cancer (RCC) (histologically or cytologically) whose physician has already decided to initiate a treatment with nivolumab with or without ipilimumab for the first time for the treatment of RCC, according to the label approved in France
- NOTE: Nivolumab with ipilimumab is indicated for the first-line treatment of adult participants with intermediate/poor-risk advanced RCC
Exclusion
- Primary diagnosis of a cancer other than advanced RCC within the past five years, ie, a cancer other than RCC that requires systemic or other treatment
- Previously treated with anti-PD1, anti-programmed death-ligand 1 (anti-PDL1) or anti-CTLA4 therapy
- Currently included in an interventional clinical trial for advanced or RCC. Participants who have completed participation in an interventional trial; or who are not receiving study drug anymore and who are only followed-up for overall survival (OS) can be enrolled
- Pregnant women and participants under guardianship
Key Trial Info
Start Date :
January 21 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2025
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT03455452
Start Date
January 21 2018
End Date
November 30 2025
Last Update
June 25 2025
Active Locations (1)
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1
Local Institution - 0001
Paris, France, 75002