The purpose of this study is to collect data to describe the safety and effectiveness of cabozantinib and nivolumab in combination as a first-line treatment in adults with aRCC with clear cell-component, according to real-world clinical practice. The decision to prescribe cabozantinib and nivolumab in combination will be made prior to, and independently from, the decision to enrol the participant in study.
Study Type
OBSERVATIONAL
Enrollment
311
Overall survival (OS) rate (death of any cause) from the start of cabozantinib in combination with nivolumab.
Time frame: At 18 months follow up
Tumor median progression-free survival (PFS) time
Including clinical and radiographic assessments defined as the time between the start date of cabozantinib in combination with nivolumab and the date of progression or death of any cause. The Kaplan-Meier method will be used to estimate median PFS.
Time frame: Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression
Proportion of participants who achieve partial or complete response (Objective Response Rate (ORR))
Assessed by the investigator
Time frame: Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression
Duration of response (DOR)
Defined as the interval from the date of first response (complete or partial) to treatment with cabozantinib in combination with nivolumab, to progressive disease or death
Time frame: Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression
Proportion of participants who achieve complete response, partial response or stable disease (Disease Control Rate (DCR)).
Time frame: Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression.
Time of response (TTR)
Defined as the time between the start date of cabozantinib in combination with nivolumab and date of first response (complete or partial).
Time frame: Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression
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CHU St Pierre & Brugmann
Brussels, Belgium
Jessa Ziekenhuis
Hasselt, Belgium
CHU Namur Mont-Godinne
Yvoir, Belgium
Centre Hospitalier Universitaire (CHU) de Angers
Angers, France
Hopital de Mercy- CHR Metz Thionville
Ars-Laquenexy, France
Institut Ste Catherine - Institut du Cancer Avignon Provence
Avignon, France
Centre Hospitalier Régional Universitaire de Besançon - Jean Minjoz
Besançon, France
ICONE
Bezannes, France
Groupe Hospitalier Saint-André (Bordeaux)
Bordeaux, France
Institut Bergonié
Bordeaux, France
...and 56 more locations
Pattern of use of cabozantinib under real-world practice conditions.
Time frame: Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression
Pattern of use of nivolumab under real-world practice conditions.
Time frame: Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression
Incidence of treatment-emergent Adverse Events (TEAEs) including nonserious Adverse Events (AEs), and Serious Advers Events (SAEs).
All AEs will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA) and will be classified by MedDRA PT and SOC.
Time frame: Up to 42 months or disease progression
Change in disease-related symptoms
Assessed by the Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index - Disease Related Symptoms (FKSI-DRS) questionnaire
Time frame: Change from baseline at each visit up to 42 months
Change in pain
Assessed by the Numerical Pain Rating Scale (NPRS)
Time frame: Change from baseline at each visit up to 42 months
Percentage of participants receiving subsequent anticancer therapies following cabozantinib and nivolumab discontinuation
Including: Sequences of treatment; drug names and duration of treatment; and reason for end of treatment line
Time frame: Up to 42 months.