Clinical trial NCT03455452: Non-Interventional Study (NIS) of Nivolumab With or Without Ipilimumab in Participants With Advanced Kidney Cancer
Official title: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Renal Cell Carcinoma
Renal Cell Cancer
Adenocarcinoma Of Kidney
Adenocarcinoma, Renal Cell
Kidney Cancer
Cancer of the Kidney
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-03-06
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants who are at least 18 of age at the time of the treatment decision with the diagnosis of advanced renal cell cancer (RCC) (histologically or cytologically confirmed) and whose physician has already decided to initiate a treatment with nivolumab or with nivolumab plus ipilimumab for the first time for the treatment of RCC, according to the label approved in France.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 3 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 3 years
measure: Progression Free Survival (PFS)
timeFrame: Up to 3 years
measure: Overall Response Rate (ORR)
timeFrame: Up to 3 years
measure: Best Overall Response Rate (BORR)
timeFrame: Up to 3 years
measure: Best Overall Response (BOR)
timeFrame: Up to 3 years
measure: Distribution of socio-demographic characteristics of participants
timeFrame: Approximately 3 years
measure: Distribution of clinical characteristics of participants
timeFrame: Approximately 3 years
measure: Distribution of management of participants with treatment-related adverse events (AEs)
timeFrame: Approximately 3 years
measure: Distribution of management of participants according to Memorial Sloan Kettering Cancer Center (MSKCC) score
timeFrame: At baseline
measure: Distribution of management of participants according to International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) score
timeFrame: At baseline
measure: Distribution of treatment patterns in participants with advanced Renal Cell Carcinoma (RCC)
timeFrame: Approximately 3 years
measure: Distribution of incidence of AEs
timeFrame: Approximately 3 years
measure: Distribution of Severity of AEs
timeFrame: Approximately 3 years
measure: Distribution of management of AEs
timeFrame: Approximately 3 years
measure: Health-related quality of life of participants using Functional Assessment of Cancer Therapy -Kidney Symptom Index (FKSI-19) questionnaires
timeFrame: Approximately 3 years
measure: Health-related quality of life of participants using European Quality of Life-5 Dimensions (EQ-5D) questionnaires
timeFrame: Approximately 3 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Local Institution - 0001
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: