NCT05361434CompletedNot Applicable
A Prospective Observational International Study of Cabozantinib Tablets in Combination With Nivolumab as First-line Treatment of Advanced Renal Cell Carcinoma in Adults
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ipsen
- Enrollment
- 311
- Locations
- 133
- Primary Endpoint
- Overall survival (OS) rate (death of any cause) from the start of cabozantinib in combination with nivolumab.
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Overall survival (OS) rate (death of any cause) from the start of cabozantinib in combination with nivolumab.
Time Frame: At 18 months follow up
Secondary Outcomes
- Proportion of participants who achieve complete response, partial response or stable disease (Disease Control Rate (DCR)).(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).(Up to 42 months or disease progression)
- Change in pain(Change from baseline at each visit up to 42 months)
- Duration of response (DOR)(Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression)
- Time of response (TTR)(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.(Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression)
- Tumor median progression-free survival (PFS) time(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))(Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression)
- Pattern of use of cabozantinib under real-world practice conditions.(Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression)
- Change in disease-related symptoms(Change from baseline at each visit up to 42 months)
- Percentage of participants receiving subsequent anticancer therapies following cabozantinib and nivolumab discontinuation(Up to 42 months.)
Investigators
Study Sites (133)
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