Advanced or Metastatic Renal Cell CarcinomaREPLICANCT04106349
Observational Real-life Study of Cabozantinib in Monotherapy or in Combination With Nivolumab in Advanced Renal Cell Carcinoma (RCC)
An observational study of Advanced or Metastatic Renal Cell Carcinoma, run by Ipsen at 20 sites in Belgium.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Renal Cell Carcinoma
- How many people
- 150 participants
- Where
- 20 sitesBelgium
- Study dates
- 3 Mar 2020to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: advanced or metastatic renal cell carcinoma
Who may be able to join
- 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
Who cannot join
- Participation in another interventional clinical study at the same time
- Previous participation in this clinical study
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Belgium20 sites
Onze-Lieve-vrouw Ziekenhuis Aalst
Aalst, 9300
Imeldaziekenhuis
Bonheiden, 2820
Clinique Saint-Luc Bouge
Bouge, 5004
AZ Sint-Jan Brugge
Bruges, 8000
AZ Sint-Lucas
Bruges, 8310
UZ Brussel
Brussels, 1090
Ziekenhuis Oost-Limburg Genk
Genk, 3600
Universitair Ziekenhuis Gent
Ghent, 9000
Hôpital de Jolimont
La Louvière, 7100
CHC MontLegia
Liège, 4000
CHR Citadelle Liège
Liège, 4000
CHU Liège / Sart-Tilman
Liège, 4000
Hôpital Ambroise-Paré Mons
Mons, 7000
CHU Charleroi - site André Vésale
Montigny-le-Tilleul, 6110
Clinique Saint-Pierre
Ottignies, 1340
AZ Delta
Roeselare, 8800
AZ Glorieux
Ronse, 9600
CHWAPI
Tournai, 7500
AZ Turnhout
Turnhout, 2300
CHR Verviers
Verviers, 4800
About this study
Official title: REPLICA: Real Patient Life Treatment With Cabozantinib in Monotherapy or in Combination With Nivolumab in Patients With Advanced or Metastatic RCC: a Descriptive and Prospective Non Interventional Study.
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)
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1st line | Not described | |
| 2nd line | Not described | |
| later lines | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment line
Treatment line will be assessed at baseline. It is a percentage of patients receiving cabozantinib as 1st, 2nd or later lines of treatment or cabozantinib in monotherapy or in combination with nivolumab as 1st line of treatment.
Measured: Baseline
Dose reductions and reasons
Number of dose reductions and reason
Measured: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Treatment interruptions and reason
Number of treatment interruptions and reason
Measured: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Treatment discontinuations and reason
Number of patients with permanent discontinuation and reason
Measured: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Alternative dose schedule
Number of patients with schedules other than 1 pill at fixed dose/day for the total treatment period
Measured: From baseline until the end of study up to 9 months
Mean number of any dose modification
Measured: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Median number of any dose modification
Measured: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Median time to any first dose modification
Measured: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Median time to end of treatment
Measured: From baseline until the end of study up to 9 months
Duration of treatment exposure
Measured: From baseline until the end of study up to 9 months
Dose prescribed at initiation
Number of patients with dose of 60 mg/day, 40 mg/day or 20 mg/day at baseline
Measured: Baseline
Average daily dose
Estimation of average daily dose received by subject during the treatment exposure
Measured: From baseline until the end of study up to 9 months
Secondary outcomes (4)
Change in Quality of Life score
Changes in quality of life data by comparing changes in scores on Using the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (NFKSI-19). It describes the severity, interference, and frequency rates.
Measured: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Progression Free Survival (PFS)
Radiological progression using RECIST 1.1 or investigator assessed or according to local standard of care or death; PFS evaluated at least every 12 weeks under treatment with cabozantinib
Measured: From baseline until the end of study up to 9 months
Objective Response Rate
Percent of patients with partial and complete response during the treatment with cabozantinib
Measured: From baseline until the end of study up to 9 months
Disease Control Rate
Percent of patients with stable disease, partial and complete response during the treatment with cabozantinib
Measured: From baseline until the end of study up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start3 Mar 2020
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106349
- Sponsor's protocol ID
- A-BE-60000-047
- Acronym
- REPLICA
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2019
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REPLICA: Real Patient Life Treatment With Cabozantinib in Monotherapy or in Combination With Nivolumab in Patients With Advanced or Metastatic RCC: a Descriptive and Prospective Non Interventional Study.
- ClinicalTrials.gov ID
- NCT04106349
- Acronym / sponsor ID
- REPLICA / A-BE-60000-047
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 27 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1st line | – | – |
| 2nd line | – | – |
| later lines | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- advanced or metastatic renal cell carcinoma
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Participation in another interventional clinical study at the same time
- Previous participation in this clinical study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatment line
Time frame: Baseline
Treatment line will be assessed at baseline. It is a percentage of patients receiving cabozantinib as 1st, 2nd or later lines of treatment or cabozantinib in monotherapy or in combination with nivolumab as 1st line of treatment.
Dose reductions and reasons
Time frame: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Number of dose reductions and reason
Treatment interruptions and reason
Time frame: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Number of treatment interruptions and reason
Treatment discontinuations and reason
Time frame: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Number of patients with permanent discontinuation and reason
Alternative dose schedule
Time frame: From baseline until the end of study up to 9 months
Number of patients with schedules other than 1 pill at fixed dose/day for the total treatment period
Mean number of any dose modification
Time frame: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Median number of any dose modification
Time frame: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Median time to any first dose modification
Time frame: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Median time to end of treatment
Time frame: From baseline until the end of study up to 9 months
Duration of treatment exposure
Time frame: From baseline until the end of study up to 9 months
Dose prescribed at initiation
Time frame: Baseline
Number of patients with dose of 60 mg/day, 40 mg/day or 20 mg/day at baseline
Average daily dose
Time frame: From baseline until the end of study up to 9 months
Estimation of average daily dose received by subject during the treatment exposure
4 secondary outcomes
Change in Quality of Life score
Time frame: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Progression Free Survival (PFS)
Time frame: From baseline until the end of study up to 9 months
Objective Response Rate
Time frame: From baseline until the end of study up to 9 months
Disease Control Rate
Time frame: From baseline until the end of study up to 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced or Metastatic Renal Cell Carcinoma, run by Ipsen at 20 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment line (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.