Observational Real-life Study of Cabozantinib in Monotherapy or in Combination With Nivolumab in Advanced Renal Cell Carcinoma (RCC)
REPLICA
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.
1 other identifier
observational
150
1 country
20
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2020
Longer than P75 for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2019
CompletedFirst Posted
Study publicly available on registry
September 27, 2019
CompletedStudy Start
First participant enrolled
March 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
April 30, 2026
April 1, 2026
7.1 years
September 25, 2019
April 29, 2026
Conditions
Outcome Measures
Primary Outcomes (12)
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.
Baseline
Dose reductions and reasons
Number of dose reductions and reason
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
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
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
From baseline until the end of study up to 9 months
Mean number of any dose modification
From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Median number of any dose modification
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
From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Median time to end of treatment
From baseline until the end of study up to 9 months
Duration of treatment exposure
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
Baseline
Average daily dose
Estimation of average daily dose received by subject during the treatment exposure
From baseline until the end of study up to 9 months
Secondary Outcomes (4)
Change in Quality of Life score
From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Progression Free Survival (PFS)
From baseline until the end of study up to 9 months
Objective Response Rate
From baseline until the end of study up to 9 months
Disease Control Rate
From baseline until the end of study up to 9 months
Study Arms (3)
1st line
2nd line
later lines
Eligibility Criteria
advanced or metastatic renal cell carcinoma
You may qualify if:
- 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
You may not qualify if:
- Participation in another interventional clinical study at the same time
- Previous participation in this clinical study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (20)
Onze-Lieve-vrouw Ziekenhuis Aalst
Aalst, 9300, Belgium
Imeldaziekenhuis
Bonheiden, 2820, Belgium
Clinique Saint-Luc Bouge
Bouge, 5004, Belgium
AZ Sint-Jan Brugge
Bruges, 8000, Belgium
AZ Sint-Lucas
Bruges, 8310, Belgium
UZ Brussel
Brussels, 1090, Belgium
Ziekenhuis Oost-Limburg Genk
Genk, 3600, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Hôpital de Jolimont
La Louvière, 7100, Belgium
CHC MontLegia
Liège, 4000, Belgium
CHR Citadelle Liège
Liège, 4000, Belgium
CHU Liège / Sart-Tilman
Liège, 4000, Belgium
Hôpital Ambroise-Paré Mons
Mons, 7000, Belgium
CHU Charleroi - site André Vésale
Montigny-le-Tilleul, 6110, Belgium
Clinique Saint-Pierre
Ottignies, 1340, Belgium
AZ Delta
Roeselare, 8800, Belgium
AZ Glorieux
Ronse, 9600, Belgium
CHWAPI
Tournai, 7500, Belgium
AZ Turnhout
Turnhout, 2300, Belgium
CHR Verviers
Verviers, 4800, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2019
First Posted
September 27, 2019
Study Start
March 3, 2020
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2027
Last Updated
April 30, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.
- Access Criteria
- Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).
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.