Clinical trial NCT04106349: Observational Real-life Study of Cabozantinib in Monotherapy or in Combination With Nivolumab in Advanced Renal Cell Carcinoma (RCC)
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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Advanced or Metastatic Renal Cell Carcinoma
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2019-09-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: advanced or metastatic renal cell carcinoma

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)


Eligibility criteria: 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

Exclusion Criteria:

* Participation in another interventional clinical study at the same time
* Previous participation in this clinical study

Primary outcomes:
measure: Treatment line
timeFrame: Baseline
measure: Dose reductions and reasons
timeFrame: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
measure: Treatment interruptions and reason
timeFrame: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
measure: Treatment discontinuations and reason
timeFrame: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
measure: Alternative dose schedule
timeFrame: From baseline until the end of study up to 9 months
measure: Mean number of any dose modification
timeFrame: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
measure: Median number of any dose modification
timeFrame: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
measure: Median time to any first dose modification
timeFrame: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
measure: Median time to end of treatment
timeFrame: From baseline until the end of study up to 9 months
measure: Duration of treatment exposure
timeFrame: From baseline until the end of study up to 9 months
measure: Dose prescribed at initiation
timeFrame: Baseline
measure: Average daily dose
timeFrame: From baseline until the end of study up to 9 months
Secondary outcomes:
measure: Change in Quality of Life score
timeFrame: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
measure: Progression Free Survival (PFS)
timeFrame: From baseline until the end of study up to 9 months
measure: Objective Response Rate
timeFrame: From baseline until the end of study up to 9 months
measure: Disease Control Rate
timeFrame: From baseline until the end of study up to 9 months
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Onze-Lieve-vrouw Ziekenhuis Aalst
city: Arlon
country: Belgium
facility: Vivalia Hôpital d'Arlon
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis
city: Bouge
country: Belgium
facility: Clinique Saint-Luc Bouge
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge
city: Brugge
country: Belgium
facility: AZ Sint-Lucas
city: Brussels
country: Belgium
facility: Hôpital Erasme
city: Brussels
country: Belgium
facility: UZ Brussel
city: Brussels
country: Belgium
facility: Chirec Delta
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg Genk
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Hasselt
country: Belgium
facility: Virga Jessa Ziekenhuis
city: La Louvière
country: Belgium
facility: Hôpital de Jolimont
city: Liège
country: Belgium
facility: CHC MontLegia
city: Liège
country: Belgium
facility: CHR Citadelle Liège
city: Liège
country: Belgium
facility: CHU Liège / Sart-Tilman
city: Mons
country: Belgium
facility: Hôpital Ambroise-Paré Mons
city: Montigny-le-Tilleul
country: Belgium
facility: CHU Charleroi - site André Vésale
city: Ottignies
country: Belgium
facility: Clinique Saint-Pierre
city: Roeselare
country: Belgium
facility: AZ Delta
city: Ronse
country: Belgium
facility: AZ Glorieux
city: Tournai
country: Belgium
facility: CHWAPI
city: Turnhout
country: Belgium
facility: AZ Turnhout
city: Verviers
country: Belgium
facility: CHR Verviers
city: Yvoir
country: Belgium
facility: UCL Namur - site Godinne
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: