Active — Not RecruitingNot Applicable

Observational Real-life Study of Cabozantinib in Monotherapy or in Combination With Nivolumab in Advanced Renal Cell Carcinoma (RCC)

Belgium150 participantsStarted 2020-03-03

Plain-language summary

The purpose of this study is to describe the real-life use of Cabometyx® in monotherapy or in combination with nivolumab in Belgium in patients with advanced or metastatic Renal Cell Carcinoma (1st, 2nd and later lines of treatment)

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Males or females aged 18 years and older * Patients scheduled to receive Cabometyx® in monotherapy or in combination with nivolumabfor advanced or metastatic renal cell carcinoma * Decision to treat patients with Cabometyx® in monotherapy or in combination with nivolumab has to be taken prior to and independent from participation in the clinical study * Provision of written informed consent Exclusion Criteria: * Participation in another interventional clinical study at the same time * Previous participation in this clinical study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Treatment line

Timeframe: Baseline

Dose reductions and reasons

Timeframe: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop

Treatment interruptions and reason

Timeframe: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop

Treatment discontinuations and reason

Timeframe: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop

Alternative dose schedule

Timeframe: From baseline until the end of study up to 9 months

Mean number of any dose modification

Timeframe: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop

Median number of any dose modification

Timeframe: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop

Trial details

NCT IDNCT04106349

SponsorIpsen

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-03-31

View on ClinicalTrials.gov More Advanced or Metastatic Renal Cell Carcinoma trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Treatment line

Timeframe: Baseline

Dose reductions and reasons

Timeframe: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop

Treatment interruptions and reason

Timeframe: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop

Treatment discontinuations and reason

Timeframe: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop

Alternative dose schedule

Timeframe: From baseline until the end of study up to 9 months

Mean number of any dose modification

Timeframe: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop

Median number of any dose modification

Timeframe: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop