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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05361434




Registration number
NCT05361434
Ethics application status
Date submitted
29/04/2022
Date registered
4/05/2022

Titles & IDs
Public title
A Study of the Effectiveness of Cabozantinib in Combination With Nivolumab as First-line Treatment of Advanced Renal Cell Carcinoma (aRCC) in Adults
Scientific title
A Prospective Observational International Study of Cabozantinib Tablets in Combination With Nivolumab as First-line Treatment of Advanced Renal Cell Carcinoma in Adults
Secondary ID [1] 0 0
CLIN-60000-452
Universal Trial Number (UTN)
Trial acronym
CaboCombo
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced 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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival (OS) rate (death of any cause) from the start of cabozantinib in combination with nivolumab.
Timepoint [1] 0 0
At 18 months follow up
Secondary outcome [1] 0 0
Tumor median progression-free survival (PFS) time
Timepoint [1] 0 0
Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression
Secondary outcome [2] 0 0
Proportion of participants who achieve partial or complete response (Objective Response Rate (ORR))
Timepoint [2] 0 0
Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression
Secondary outcome [3] 0 0
Duration of response (DOR)
Timepoint [3] 0 0
Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression
Secondary outcome [4] 0 0
Proportion of participants who achieve complete response, partial response or stable disease (Disease Control Rate (DCR)).
Timepoint [4] 0 0
Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression.
Secondary outcome [5] 0 0
Time of response (TTR)
Timepoint [5] 0 0
Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression
Secondary outcome [6] 0 0
Pattern of use of cabozantinib under real-world practice conditions.
Timepoint [6] 0 0
Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression
Secondary outcome [7] 0 0
Pattern of use of nivolumab under real-world practice conditions.
Timepoint [7] 0 0
Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression
Secondary outcome [8] 0 0
Incidence of treatment-emergent Adverse Events (TEAEs) including nonserious Adverse Events (AEs), and Serious Advers Events (SAEs).
Timepoint [8] 0 0
Up to 42 months or disease progression
Secondary outcome [9] 0 0
Change in disease-related symptoms
Timepoint [9] 0 0
Change from baseline at each visit up to 42 months
Secondary outcome [10] 0 0
Change in pain
Timepoint [10] 0 0
Change from baseline at each visit up to 42 months
Secondary outcome [11] 0 0
Percentage of participants receiving subsequent anticancer therapies following cabozantinib and nivolumab discontinuation
Timepoint [11] 0 0
Up to 42 months.

Eligibility
Key inclusion criteria
* Participants with diagnosis of aRCC with clear-cell component
* Participants with no prior systemic treatment for aRCC with clear-cell component;
* Physician-initiated decision to treat with cabozantinib and nivolumab in combination (prior to study enrolment), according to Cabometyx® and Opdivo® approved local labels;
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Current participation in an investigational program with any intervention which could possibly interfere the treatment and impact this study;
* History of allergy or hypersensitivity to Cabometyx® or Opdivo® components.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/11/2026
Actual
Sample size
Target
Accrual to date
Final
311
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Bruxelles
Country [2] 0 0
Belgium
State/province [2] 0 0
Hasselt
Country [3] 0 0
Belgium
State/province [3] 0 0
Yvoir
Country [4] 0 0
France
State/province [4] 0 0
Angers
Country [5] 0 0
France
State/province [5] 0 0
Ars-Laquenexy
Country [6] 0 0
France
State/province [6] 0 0
Avignon
Country [7] 0 0
France
State/province [7] 0 0
Besançon
Country [8] 0 0
France
State/province [8] 0 0
Bezannes
Country [9] 0 0
France
State/province [9] 0 0
Bordeaux
Country [10] 0 0
France
State/province [10] 0 0
Boulogne-sur-Mer
Country [11] 0 0
France
State/province [11] 0 0
Bourg-en-Bresse
Country [12] 0 0
France
State/province [12] 0 0
Brest
Country [13] 0 0
France
State/province [13] 0 0
Cabestany
Country [14] 0 0
France
State/province [14] 0 0
Clermont-Ferrand
Country [15] 0 0
France
State/province [15] 0 0
Créteil
Country [16] 0 0
France
State/province [16] 0 0
Dijon
Country [17] 0 0
France
State/province [17] 0 0
Fréjus
Country [18] 0 0
France
State/province [18] 0 0
La Roche-sur-Yon
Country [19] 0 0
France
State/province [19] 0 0
La Rochelle
Country [20] 0 0
France
State/province [20] 0 0
La Tronche
Country [21] 0 0
France
State/province [21] 0 0
Lille
Country [22] 0 0
France
State/province [22] 0 0
Lyon
Country [23] 0 0
France
State/province [23] 0 0
Nantes
Country [24] 0 0
France
State/province [24] 0 0
Orléans
Country [25] 0 0
France
State/province [25] 0 0
Paris
Country [26] 0 0
France
State/province [26] 0 0
Poitiers
Country [27] 0 0
France
State/province [27] 0 0
Rouen
Country [28] 0 0
France
State/province [28] 0 0
Saint-Nazaire
Country [29] 0 0
France
State/province [29] 0 0
Strasbourg
Country [30] 0 0
France
State/province [30] 0 0
Suresnes
Country [31] 0 0
France
State/province [31] 0 0
Tours
Country [32] 0 0
France
State/province [32] 0 0
Valenciennes
Country [33] 0 0
France
State/province [33] 0 0
Vandœuvre-lès-Nancy
Country [34] 0 0
France
State/province [34] 0 0
Épagny
Country [35] 0 0
Greece
State/province [35] 0 0
Athens
Country [36] 0 0
Greece
State/province [36] 0 0
Chaïdári
Country [37] 0 0
Greece
State/province [37] 0 0
Thessaloníki
Country [38] 0 0
Italy
State/province [38] 0 0
Macerata
Country [39] 0 0
Italy
State/province [39] 0 0
Meldola
Country [40] 0 0
Italy
State/province [40] 0 0
Milano
Country [41] 0 0
Italy
State/province [41] 0 0
Napoli
Country [42] 0 0
Italy
State/province [42] 0 0
Orbassano
Country [43] 0 0
Italy
State/province [43] 0 0
Padova
Country [44] 0 0
Italy
State/province [44] 0 0
Pozzuoli
Country [45] 0 0
Italy
State/province [45] 0 0
Ravenna
Country [46] 0 0
Italy
State/province [46] 0 0
Roma
Country [47] 0 0
Korea, Republic of
State/province [47] 0 0
Jeongnam
Country [48] 0 0
Korea, Republic of
State/province [48] 0 0
Seoul
Country [49] 0 0
Norway
State/province [49] 0 0
Lørenskog
Country [50] 0 0
Saudi Arabia
State/province [50] 0 0
Jeddah
Country [51] 0 0
Saudi Arabia
State/province [51] 0 0
Riyadh
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Belfast
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Edinburgh

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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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?
Where patient data can be anonymised, Ipsen will share all individual participant data that underlie the results reported in the published journal article with qualified researchers who provide a valid research question. Study documents, such as the study protocol and clinical study report, are not always available.
When will data be available (start and end dates)?
Data are available beginning 6 months and ending 5 years after the publication of the findings in a journal; after this time, only raw data may be available.
Available to whom?
Proposals should be submitted to DataSharing@ipsen.com and will be assessed by a scientific review board.
Available for what types of analyses?
How or where can data be obtained?


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/NCT05361434