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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Renal Cell Carcinoma

Study type: Observational

Funder types: Industry

Identifiers

NCT02940639

CA209-653

Details and patient eligibility

About

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

Enrollment: 499 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

499 participants in 2 patient groups

Cohort 1

Description:

Participants with advanced/metastatic renal cell cancer (RCC) starting nivolumab monotherapy after prior therapy

Cohort 2

Description:

Participants with advanced/metastatic RCC starting 1st line therapy with nivolumab and ipilimumab combination therapy, in intermediate/poor risk participants