NCT03455452CompletedNot Applicable
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
Bristol-Myers Squibb2 sites in 1 country623 target enrollmentStarted: January 21, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 623
- Locations
- 2
- Primary Endpoint
- Overall Survival (OS)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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
Outcomes
Primary Outcomes
Overall Survival (OS)
Time Frame: Up to 3 years
By Cohort
Secondary Outcomes
- Progression Free Survival (PFS)(Up to 3 years)
- Best Overall Response Rate (BORR)(Up to 3 years)
- Overall Survival (OS)(Up to 3 years)
- Overall Response Rate (ORR)(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)
- Health-related quality of life of participants using European Quality of Life-5 Dimensions (EQ-5D) questionnaires(Approximately 3 years)
Investigators
Study Sites (2)
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