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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

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
Trial website
Trial related presentations / publications
Public notes

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
clinical.trials@ipsen.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
When will data be available (start and end dates)?
Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
Available to whom?
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/members/ourmembers/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04106349