Real-Life Effectiveness and Safety in Participants With Advanced/Metastatic Renal Cell Carcinoma Starting 1st Line Nivolumab and Ipilimumab Combination Therapy or Nivolumab Monotherapy After Prior Therapy

Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02940639
• Other study ID #: CA209-653
• Status: Active, not recruiting
• Start date: October 27, 2016
• Est. completion date: December 15, 2025

Study information

• Verified date: May 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 499
• Est. completion date: December 15, 2025
• Est. primary completion date: December 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Locations

Country	Name	City	State
Germany	Local Institution	Jena

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	In participants with nivolumab and ipilimumab or nivolumab therapy	Approximately 5 years
Secondary	Overall Survival (OS)	Separate by nivolumab and ipilimumab or nivolumab therapy, estimated overall lines of therapy, per line of therapy, per cohort, per index date (initial diagnosis vs start of therapy in the trial) and per subgroups of interest.	Approximately 5 years
Secondary	Progression-Free Survival (PFS)		Approximately 5 years
Secondary	Overall response rate (ORR)		Approximately 5 years
Secondary	Best Overall Response (BOR)		Approximately 5 years
Secondary	Best Overall Response Rate (BORR)		Approximately 5 years
Secondary	Duration of Response		Approximately 5 years
Secondary	Distribution of socio-demographic characteristics	Socio-demographic characteristics (Gender, Height, Weight, Age) will be summarized using descriptive statistics.	Approximately 5 years
Secondary	Distribution of clinical characteristics	Clinical characteristics (Initial Diagnosis of RCC, Histological subtypes, Performance status, Comorbidities, history of cancer) will be summarized using descriptive statistics	Approximately 5 years
Secondary	Distribution of Renal Cell Carcinoma (RCC) Treatment History		At Baseline
Secondary	Distribution of Nivolumab Treatment Characteristics	Nivolumab monotherapy (cohort 1) or nivolumab and ipilimumab combination therapy (cohort 2)	At initiation - index date, baseline
Secondary	Distribution of Treatment Patterns	Details on prior and evolution of current treatment patterns	Approximately 5 years
Secondary	Incidence rate of Adverse Events (AEs), treatment-related AEs, select AEs and other immune-related AEs		Approximately 5 years
Secondary	Distribution of Adverse Events (AE) characteristics		Approximately 5 years
Secondary	Distribution of severity of Adverse Events (AEs)		Approximately 5 years
Secondary	Distribution of management of Adverse Events (AEs)		Approximately 5 years
Secondary	Quality of Life as assessed by Functional Assessment of Cancer Therapy - Kidney Symptom Index (FKSI-19) Questionnaire		Approximately 5 years
Secondary	Utility as assessed by European Quality of Life-5 Dimensions (EQ-5D) Questionnaire		Approximately 5 years

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form