Adenocarcinoma Of Kidney, Adenocarcinoma, Renal Cell, Cancer of the Kidney, Kidney Cancer, Renal Cell Cancer, Renal Cell Carcinoma
Conditions
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 without ipilimumab for the first time and within the market authorization approval.
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to 3 years | By Cohort |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to 3 years | — |
| Progression Free Survival (PFS) | Up to 3 years | — |
| Overall Response Rate (ORR) | Up to 3 years | — |
| Best Overall Response Rate (BORR) | Up to 3 years | — |
| Best Overall Response (BOR) | Up to 3 years | — |
| Distribution of socio-demographic characteristics of participants | Approximately 3 years | — |
| Distribution of clinical characteristics of participants | Approximately 3 years | — |
| Distribution of management of participants with treatment-related adverse events (AEs) | Approximately 3 years | — |
| Distribution of management of participants according to Memorial Sloan Kettering Cancer Center (MSKCC) score | At baseline | — |
| Distribution of management of participants according to International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) score | At baseline | — |
| Distribution of treatment patterns in participants with advanced Renal Cell Carcinoma (RCC) | Approximately 3 years | — |
| Distribution of incidence of AEs | Approximately 3 years | — |
| Distribution of Severity of AEs | Approximately 3 years | — |
| Distribution of management of AEs | Approximately 3 years | — |
| Health-related quality of life of participants using Functional Assessment of Cancer Therapy -Kidney Symptom Index (FKSI-19) questionnaires | Approximately 3 years | The FKSI-19 will be graded by the patient on a scale from 0 to 4 (range "not at all to very much") |
| Health-related quality of life of participants using European Quality of Life-5 Dimensions (EQ-5D) questionnaires | Approximately 3 years | The EQ-5D descriptive system consists of 5 dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression, each with 3 levels (eg, no problems, moderate problems, extreme problems) |
Countries
France
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed