CaboCHECK - Cabozantinib in Adult Patients With Advanced Renal Cell Carcinoma Following Prior Systemic Check Point Inhibition Therapy: a Retrospective, Non-interventional Study

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest56 enrolled

Overview

This is a non-interventional study to retrospectively evaluate the safety and to describe the effectiveness of cabozantinib after immunoncologic treatment with nivolumab or nivolumab plus ipilimumab in routine clinical practice. It consists of a retrospective chart review of patients who have already completed treatment with cabozantinib after nivolumab or nivolumab plus ipilimumab before inclusion.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Advanced Renal Cell Carcinoma (All Subtypes)Metastatic Renal Cell Carcinoma (All Subtypes)

Interventions

DocumentationOTHER

Retrospective chart review of patients who have already completed treatment with cabozantinib after nivolumab or nivolumab plus ipilimumab before inclusion.

Medical Language ↔ Plain English

Inclusion Criteria: 1. Written informed consent and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject 2. Patients with advanced or metastatic renal cell carcinoma, including all subtypes 3. Age ≥ 18 years 4. Completion of treatment with nivolumab or nivolumab / ipilimumab combination therapy (any line of therapy) directly followed by cabozantinib treatment Exclusion Criteria: 1. Patients who are unable to consent because they do not understand the nature, significance and implications of the observational trial 2. Involvement in the planning and / or conduct of the study (applies to both Ipsen staff and/or staff of sponsor and study site)

Outcomes

Primary Outcomes

Incidence of serious adverse events

Incidence of serious adverse events at least possibly related to cabozantinib treatment during and up to 30 days after the end of cabozantinib treatment