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

Ipsen

Status: Active, not recruiting

Conditions: Advanced Renal Cell Carcinoma

Study type: Observational

Funder types: Industry

Identifiers

NCT05361434

CLIN-60000-452

Details and patient eligibility

About

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.

Enrollment: 311 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.