Clinical trial NCT02940639: 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
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Renal Cell Carcinoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-10-21
Enrollment: 499
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult participants who are at least 18 years of age at the time of the treatment decision with the diagnosis of advanced/metastatic RCC (histologically or cytologically confirmed) and whose physician has already decided to initiate a treatment with 1st line nivolumab and ipilimumab nivolumab combination therapy in intermediate/poor risk participants according to International Metastatic RCC Database Consortium (IMDC) score or with nivolumab monotherapy after prior therapy for the first time for the treatment of advanced/metastatic RCC, according to the label approved in Germany.

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


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.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Approximately 5 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Approximately 5 years
measure: Progression-Free Survival (PFS)
timeFrame: Approximately 5 years
measure: Overall response rate (ORR)
timeFrame: Approximately 5 years
measure: Best Overall Response (BOR)
timeFrame: Approximately 5 years
measure: Best Overall Response Rate (BORR)
timeFrame: Approximately 5 years
measure: Duration of Response
timeFrame: Approximately 5 years
measure: Distribution of socio-demographic characteristics
timeFrame: Approximately 5 years
measure: Distribution of clinical characteristics
timeFrame: Approximately 5 years
measure: Distribution of Renal Cell Carcinoma (RCC) Treatment History
timeFrame: At Baseline
measure: Distribution of Nivolumab Treatment Characteristics
timeFrame: At initiation - index date, baseline
measure: Distribution of Treatment Patterns
timeFrame: Approximately 5 years
measure: Incidence rate of Adverse Events (AEs), treatment-related AEs, select AEs and other immune-related AEs
timeFrame: Approximately 5 years
measure: Distribution of Adverse Events (AE) characteristics
timeFrame: Approximately 5 years
measure: Distribution of severity of Adverse Events (AEs)
timeFrame: Approximately 5 years
measure: Distribution of management of Adverse Events (AEs)
timeFrame: Approximately 5 years
measure: Quality of Life as assessed by Functional Assessment of Cancer Therapy - Kidney Symptom Index (FKSI-19) Questionnaire
timeFrame: Approximately 5 years
measure: Utility as assessed by European Quality of Life-5 Dimensions (EQ-5D) Questionnaire
timeFrame: Approximately 5 years
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Bedke J, Grimm MO, Grunwald V. Collection of real-world data on nivolumab's effectiveness in renal cell carcinoma: rationale for an observational study. Future Oncol. 2018 May;14(11):1023-1034. doi: 10.2217/fon-2017-0637. Epub 2018 Jan 12.