Active — Not RecruitingNot Applicable

A Study of the Effectiveness of Cabozantinib in Combination With Nivolumab as First-line Treatment of Advanced Renal Cell Carcinoma (aRCC) in Adults

Belgium, France311 participantsStarted 2022-09-26

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Participants with diagnosis of aRCC with clear-cell component * Participants with no prior systemic treatment for aRCC with clear-cell component; * Physician-initiated decision to treat with cabozantinib and nivolumab in combination (prior to study enrolment), according to Cabometyx® and Opdivo® approved local labels; Exclusion Criteria: * Current participation in an investigational program with any intervention which could possibly interfere the treatment and impact this study; * History of allergy or hypersensitivity to Cabometyx® or Opdivo® components.

What they're measuring

Overall survival (OS) rate (death of any cause) from the start of cabozantinib in combination with nivolumab.

Timeframe: At 18 months follow up

Trial details

NCT IDNCT05361434

SponsorIpsen

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-10-20

View on ClinicalTrials.gov More Advanced Renal Cell Carcinoma trials