A National, Prospective, Non-Interventional Study (NIS) of Nivolumab (BMS-936558) With or Without Ipilimumab (BMS-734016) in Patients With Advanced Renal Cell Carcinoma in Real Life Setting
| Registry | NCT03455452, acronym WITNESS |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 623 (Actual) |
| Sponsor | Bristol-Myers Squibb (Industry) |
| Conditions | Renal Cell Carcinoma, Renal Cell Cancer, Adenocarcinoma Of Kidney, Adenocarcinoma, Renal Cell, Kidney Cancer, Cancer of the Kidney |
| Dates | start 2018-01-21, primary completion 2025-12-18, completion 2025-12-18, first posted 2018-03-06, last updated 2026-06-16 |
| Locations | 1 site in France |
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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 without ipilimumab for the first time and within the market authorization approval.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Cohort 1: Nivolumab | Participants diagnosed with advanced renal cell carcinoma (RCC) and whose physician has decided to initiate a treatment with Nivolumab for the first time for the treatment of RCC | ||
| Cohort 2: Nivolumab + Ipilimumab | Participants diagnosed with advanced RCC and whose physician has decided to start a new systemic therapy with nivolumab + ipilimumab for the first time for the treatment of RCC |
Sex: All, ages: 18 Years to any
Inclusion Criteria: -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 Criteria: * 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
| Facility | City | Country | Status |
|---|---|---|---|
| Local Institution - 0001 | Paris | France |