An observational study in Advanced Renal Cell Carcinoma, sponsored by Ipsen. Completed at 28 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-18.
Sponsored by Ipsen · Observational
Cabozantinib is an orally bioavailable tyrosine kinase inhibitor (TKI) approved in patients with aRCC previously treated with a Vascular Endothelial Growth Factor (VEGF)-targeted therapy. Cabozantinib has been increasingly used in routine care in second line and more in advanced or metastatic RCC in France.
Cabozantinib effectiveness and safety notably in a real-word setting are now well known, but too many questions that arise during the routine care of patients with aRCC remain unanswered by the current literature.
Obtaining data on cabozantinib effectiveness and treatment pattern in those participants subpopulations will allow physicians to improve patients care.
The aims of this study are to describe the effectiveness - in terms of Duration of Treatment (DOT), Best Overall Response (BOR) and Progression-Free Survival (PFS) - and the safety of second line cabozantinib a real-life setting in France and to address the unanswered questions that arise during the routine care of patients with aRCC treated with cabozantinib in order to improve the care of these participants.
Since 2018, cabozantinib has been increasingly used in routine care in second line and more in advanced or metastatic RCC in France.
Cabozantinib effectiveness and safety notably in a real-word setting are now well known, but too many questions that arise during the routine care of patients with aRCC remain unanswered by the current literature.
As an example, there is currently no real-world data on cabozantinib in elderly patients (≥ 75 years old); in patients with a systemic therapy after progression under cabozantinib (only one published monocentric retrospective study on 56 participants); or in long responder patients (with a disease controlled after > 12 months of cabozantinib). Obtaining data on cabozantinib effectiveness and treatment pattern in those patient subpopulations will allow physicians to improve patients care.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 252 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.
Browse Carcinoma studies →Ipsen is the lead sponsor of 282 studies on the registry; 16 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
An estimated total of 300 participants with aRCC and who started cabozantinib in 2nd line between 1st March 2018 and 1st March 2021 is planned to be included. Participants will be enrolled from approximately 25 centers in France
Exclusion Criteria:
Participants treated by cabozantinib and who received another systemic therapy post-cabozantinib.
Participants treated by cabozantinib and who had a disease controlled (CR, PR or SDi during \> 12 months after cabozantinib initiation with or without additional local treatment).
Participants treated by cabozantinib and who had a progressive disease less than 3 months after cabozantinib treatment initiation.
Participants treated by cabozantinib who received systemic therapy and/or had prolonged treatment-free interval (≥ 12 weeks) between two cabozantinib treatment periods. Participants with at least one cabozantinib rechallenge could be included in this subgroup.
Participants treated by cabozantinib and who needed 1/ a dose increase following disease progression and/or a prior reduction, Or 2/ had any dose reduction/dose interruption of cabozantinib (schedule adaptation).
Participants treated by cabozantinib and who needed concomitant local treatment (LT) by surgery or radiotherapy
Participants treated by cabozantinib and aged ≥ 75 years
Duration of treatment (DOT) of cabozantinib
Defined as the time between first and last intake of cabozantinib treatment, regardless of the treatment discontinuation reason.
Time frame: From baseline up to 18 months
Best Overall Response (BOR), until disease progression/recurrence
Defined as the proportion of participants achieving the best response among Complete Response (CR), Partial Response (PR), Stable Disease (SDi) or Disease Progression (DP), The method used for the assessment of response to treatment will be left at the discretion of the physician
Time frame: From baseline up to 18 months
Progression Free Survival (PFS).
Defined as the time from the date of first cabozantinib intake to the date of first documented progression reported by the investigator or death from any cause. Disease progression will be assessed by tumour response evaluation according to investigator assessment.
Time frame: From baseline up to 18 months
Incidence of all adverse events (AEs).
Whether they are serious/non-serious, related/unrelated experienced by the participants during cabozantinib treatment period(s).
Time frame: From baseline up to 30 days after cabozantinib last intake
Incidence of all Special Situations.
Whether they are serious/non-serious, related/unrelated experienced by the participants
Time frame: From baseline up to 30 days after cabozantinib last intake
Type of subsequent therapy
Will be described in terms of type, other TKI, Immuno-Oncology therapy (IO), mammalian Target Of Rapamycin (mTOR) inhibitors, other
Time frame: From baseline up to 18 months
DOT of subsequent therapy
Time frame: From baseline up to 18 months
Starting dose of subsequent therapy
Time frame: From baseline up to 18 months
Reasons for cabozantinib discontinuation
Time frame: From baseline up to 18 months
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Ipsen