Clinical trial · Observational
Non-Interventional Study (NIS) of Nivolumab With or Without Ipilimumab in Participants With Advanced Kidney Cancer
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
NCT03455452CI-TRIAL-00114960WITNESScompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma Of Kidney | Renal Cell Carcinoma | ALIAS | 0.90 |
| Adenocarcinoma, Renal Cell | Renal Cell Carcinoma | ALIAS | 0.90 |
| Cancer of the Kidney | Malignant Kidney Neoplasm | ALIAS | 0.90 |
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Cohort 1: Nivolumab
- description
- 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
- label
- Cohort 2: Nivolumab + Ipilimumab
- description
- 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
Primary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- Up to 3 years
- description
- By Cohort
Secondary outcomes (16)
- measure
- Overall Survival (OS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBarthelemy P, Albiges L, Escudier B, Narciso B, Bigot P, Chehimi M, Emambux S, Calcagno F, Mouillet G, Eymard JC, Schlurmann F, Bailly S, Garbay D, Berdah JF, Palmaro MB, Goupil MG, Spaeth D, Nere S, Quentric C, Vano YA, Thiery-Vuillemin A. Nivolumab in patients with advanced renal cell carcinoma in France: interim results of the observational, real-world WITNESS study. ESMO Open. 2024 Jul;9(7):103602. doi: 10.1016/j.esmoop.2024.103602. Epub 2024 Jun 18. PMID 38897136