A National, Prospective, Non-Interventional Study (NIS) in Patients With Advanced/Metastatic Renal Cell Carcinoma Starting 1st Line Nivolumab and Ipilimumab Combination Therapy or Nivolumab Monotherapy After Prior Therapy

Bristol-Myers Squibb1 site in 1 country499 target enrollmentOctober 27, 2016

ConditionsRenal Cell Carcinoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Renal Cell Carcinoma
Sponsor: Bristol-Myers Squibb
Enrollment: 499
Locations: 1
Primary Endpoint: Overall Survival (OS)
Status: Completed
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to estimate overall survival over a 5-year follow-up period among adult participants with advanced/metastatic kidney cancer, starting 1st line nivolumab and ipilimumab combination therapy or nivolumab monotherapy after prior therapy, in real-life conditions in Germany

Registry

clinicaltrials.gov

Start Date

October 27, 2016

End Date

June 3, 2025

Last Updated

9 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult participants, at least 18 years of age at time of treatment decision
•Diagnosis of advanced/metastatic renal cell carcinoma (RCC) (confirmed by histology or cytology)
•Treatment decision to initiate a treatment with nivolumab and ipilimumab or nivolumab for the first time for the treatment of advanced/metastatic RCC (according to the label approved in Germany) has already been taken
•Signed informed consent

Exclusion Criteria

•Participants with a diagnosis of a cancer other than advanced/metastatic advanced RCC within the past five years, ie, a cancer other than advanced/metastatic RCC that requires systemic or other treatment. Participants that have been treated curatively more than five years ago with no evidence of recurrence and prostate cancer patients in active surveillance can be included.
•Participants previously treated with nivolumab and/or ipilimumab
•Participants currently included in an interventional clinical trial for their locally advanced or metastatic RCC. Participants who have completed their participation in an interventional trial; or who are not receiving study drug anymore and who are only followed-up for OS can be enrolled.

Outcomes

Primary Outcomes

Overall Survival (OS)

Time Frame: Approximately 5 years

In participants with nivolumab and ipilimumab or nivolumab therapy

Secondary Outcomes

Distribution of severity of Adverse Events (AEs)(Approximately 5 years)
Distribution of Adverse Events (AE) characteristics(Approximately 5 years)
Progression-Free Survival (PFS)(Approximately 5 years)
Overall response rate (ORR)(Approximately 5 years)
Best Overall Response Rate (BORR)(Approximately 5 years)
Distribution of socio-demographic characteristics(Approximately 5 years)
Distribution of clinical characteristics(Approximately 5 years)
Incidence rate of Adverse Events (AEs), treatment-related AEs, select AEs and other immune-related AEs(Approximately 5 years)
Distribution of management of Adverse Events (AEs)(Approximately 5 years)
Quality of Life as assessed by Functional Assessment of Cancer Therapy - Kidney Symptom Index (FKSI-19) Questionnaire(Approximately 5 years)
Overall Survival (OS)(Approximately 5 years)
Distribution of Renal Cell Carcinoma (RCC) Treatment History(At Baseline)
Best Overall Response (BOR)(Approximately 5 years)
Distribution of Nivolumab Treatment Characteristics(At initiation - index date, baseline)
Distribution of Treatment Patterns(Approximately 5 years)
Utility as assessed by European Quality of Life-5 Dimensions (EQ-5D) Questionnaire(Approximately 5 years)
Duration of Response(Approximately 5 years)