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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04106349




Registration number
NCT04106349
Ethics application status
Date submitted
25/09/2019
Date registered
27/09/2019
Date last updated
28/10/2024

Titles & IDs
Public title
Observational Real-life Study of Cabozantinib in Monotherapy or in Combination With Nivolumab in Advanced Renal Cell Carcinoma (RCC)
Scientific 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.
Secondary ID [1] 0 0
A-BE-60000-047
Universal Trial Number (UTN)
Trial acronym
REPLICA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced or Metastatic Renal Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1st line -

2nd line -

later lines -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment line
Timepoint [1] 0 0
Baseline
Primary outcome [2] 0 0
Dose reductions and reasons
Timepoint [2] 0 0
From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Primary outcome [3] 0 0
Treatment interruptions and reason
Timepoint [3] 0 0
From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Primary outcome [4] 0 0
Treatment discontinuations and reason
Timepoint [4] 0 0
From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Primary outcome [5] 0 0
Alternative dose schedule
Timepoint [5] 0 0
From baseline until the end of study up to 9 months
Primary outcome [6] 0 0
Mean number of any dose modification
Timepoint [6] 0 0
From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Primary outcome [7] 0 0
Median number of any dose modification
Timepoint [7] 0 0
From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Primary outcome [8] 0 0
Median time to any first dose modification
Timepoint [8] 0 0
From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Primary outcome [9] 0 0
Median time to end of treatment
Timepoint [9] 0 0
From baseline until the end of study up to 9 months
Primary outcome [10] 0 0
Duration of treatment exposure
Timepoint [10] 0 0
From baseline until the end of study up to 9 months
Primary outcome [11] 0 0
Dose prescribed at initiation
Timepoint [11] 0 0
Baseline
Primary outcome [12] 0 0
Average daily dose
Timepoint [12] 0 0
From baseline until the end of study up to 9 months
Secondary outcome [1] 0 0
Change in Quality of Life score
Timepoint [1] 0 0
From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Secondary outcome [2] 0 0
Progression Free Survival (PFS)
Timepoint [2] 0 0
From baseline until the end of study up to 9 months
Secondary outcome [3] 0 0
Objective Response Rate
Timepoint [3] 0 0
From baseline until the end of study up to 9 months
Secondary outcome [4] 0 0
Disease Control Rate
Timepoint [4] 0 0
From baseline until the end of study up to 9 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participation in another interventional clinical study at the same time
* Previous participation in this clinical study

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/03/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Aalst
Country [2] 0 0
Belgium
State/province [2] 0 0
Arlon
Country [3] 0 0
Belgium
State/province [3] 0 0
Bonheiden
Country [4] 0 0
Belgium
State/province [4] 0 0
Bouge
Country [5] 0 0
Belgium
State/province [5] 0 0
Brugge
Country [6] 0 0
Belgium
State/province [6] 0 0
Brussels
Country [7] 0 0
Belgium
State/province [7] 0 0
Genk
Country [8] 0 0
Belgium
State/province [8] 0 0
Gent
Country [9] 0 0
Belgium
State/province [9] 0 0
Hasselt
Country [10] 0 0
Belgium
State/province [10] 0 0
La Louvière
Country [11] 0 0
Belgium
State/province [11] 0 0
Liège
Country [12] 0 0
Belgium
State/province [12] 0 0
Mons
Country [13] 0 0
Belgium
State/province [13] 0 0
Montigny-le-Tilleul
Country [14] 0 0
Belgium
State/province [14] 0 0
Ottignies
Country [15] 0 0
Belgium
State/province [15] 0 0
Roeselare
Country [16] 0 0
Belgium
State/province [16] 0 0
Ronse
Country [17] 0 0
Belgium
State/province [17] 0 0
Tournai
Country [18] 0 0
Belgium
State/province [18] 0 0
Turnhout
Country [19] 0 0
Belgium
State/province [19] 0 0
Verviers
Country [20] 0 0
Belgium
State/province [20] 0 0
Yvoir

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ipsen
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT04106349
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Ipsen Medical Director
Address 0 0
Ipsen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ipsen Recruitment Enquiries
Address 0 0
Country 0 0
Phone 0 0
see email
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04106349