Clinical trial NCT05361434: A Study of the Effectiveness of Cabozantinib in Combination With Nivolumab as First-line Treatment of Advanced Renal Cell Carcinoma (aRCC) in Adults
Official title: A Prospective Observational International Study of Cabozantinib Tablets in Combination With Nivolumab as First-line Treatment of Advanced Renal Cell Carcinoma in Adults
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Advanced Renal Cell Carcinoma
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2022-05-04
Enrollment: 311
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will include participants with advanced renal cell carcinoma with clear cell component, for whom a decision to treat with cabozantinib and nivolumab in combination has been made by the treating physician

Brief summary: The purpose of this study is to collect data to describe the safety and effectiveness of cabozantinib and nivolumab in combination as a first-line treatment in adults with aRCC with clear cell-component, according to real-world clinical practice. The decision to prescribe cabozantinib and nivolumab in combination will be made prior to, and independently from, the decision to enrol the participant in study.


Eligibility criteria: 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;

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.

Primary outcomes:
measure: Overall survival (OS) rate (death of any cause) from the start of cabozantinib in combination with nivolumab.
timeFrame: At 18 months follow up
Secondary outcomes:
measure: Tumor median progression-free survival (PFS) time
timeFrame: Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression
measure: Proportion of participants who achieve partial or complete response (Objective Response Rate (ORR))
timeFrame: Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression
measure: Duration of response (DOR)
timeFrame: Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression
measure: Proportion of participants who achieve complete response, partial response or stable disease (Disease Control Rate (DCR)).
timeFrame: Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression.
measure: Time of response (TTR)
timeFrame: Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression
measure: Pattern of use of cabozantinib under real-world practice conditions.
timeFrame: Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression
measure: Pattern of use of nivolumab under real-world practice conditions.
timeFrame: Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression
measure: Incidence of treatment-emergent Adverse Events (TEAEs) including nonserious Adverse Events (AEs), and Serious Advers Events (SAEs).
timeFrame: Up to 42 months or disease progression
measure: Change in disease-related symptoms
timeFrame: Change from baseline at each visit up to 42 months
measure: Change in pain
timeFrame: Change from baseline at each visit up to 42 months
measure: Percentage of participants receiving subsequent anticancer therapies following cabozantinib and nivolumab discontinuation
timeFrame: Up to 42 months.
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: CHU St Pierre & Brugmann
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Yvoir
country: Belgium
facility: CHU Namur Mont-Godinne
city: Angers
country: France
facility: Centre Hospitalier Universitaire (CHU) de Angers
city: Ars-Laquenexy
country: France
facility: Hopital de Mercy- CHR Metz Thionville
city: Avignon
country: France
facility: Institut Ste Catherine - Institut du Cancer Avignon Provence
city: Besançon
country: France
facility: Centre Hospitalier Régional Universitaire de Besançon - Jean Minjoz
city: Bezannes
country: France
facility: ICONE
city: Bordeaux
country: France
facility: Groupe Hospitalier Saint-André (Bordeaux)
city: Bordeaux
country: France
facility: Institut Bergonié
city: Boulogne-sur-Mer
country: France
facility: Centre Hospitalier de Boulogne-sur-mer
city: Bourg-en-Bresse
country: France
facility: Centre Hospitalier Fleyriat
city: Brest
country: France
facility: Centre Finisterien de Radiotherapie et d'Oncologie
city: Cabestany
country: France
facility: Centre d'Urologie Site Médipole - Centre Catalan d'Urologie
city: Clermont-Ferrand
country: France
facility: Centre de Lutte Contre le Cancer Jean PERRIN
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
city: Créteil
country: France
facility: Centre Hospitalier Universitaire (CHU) Henri Mondor
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Dijon
country: France
facility: Institut de Cancérologie de Bourgogne
city: Fréjus
country: France
facility: Centre Hospitalier intercommunal Saint Raphaël Frejus
city: La Roche-sur-Yon
country: France
facility: Centre Hospitalier Départemental Vendée
city: La Rochelle
country: France
facility: Groupe Hospitalier De La Rochelle - Ré - Aunis
city: La Tronche
country: France
facility: Centre Hospitalier Universitaire Grenoble Alpes
city: Lille
country: France
facility: Hôpital Privé Le Bois
city: Lyon
country: France
facility: Hopital Privé Jean Mermoz
city: Nantes
country: France
facility: Centre Hospitalier Universitaire (CHU) de Nantes - Hôtel-Dieu
city: Orléans
country: France
facility: Centre Hospitalier Régional D'orléans
city: Paris
country: France
facility: Centre Hospitalier Tenon
city: Paris
country: France
facility: Hopital Bichat -Claud Bernard
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou (HEGP)
city: Paris
country: France
facility: Hôpital Pitié-Salpétrière
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire (CHU) de Poitiers
city: Rouen
country: France
facility: CHU Charles Nicolle
city: Rouen
country: France
facility: Clinique Mathilde Oncologie médicale
city: Saint-Nazaire
country: France
facility: Centre d'Oncologie de l'Estuaire
city: Strasbourg
country: France
facility: ICANS - Institut de cancérologie Strasbourg Europe
city: Suresnes
country: France
facility: Hospital Foch - Oncology Service
city: Suresnes
country: France
facility: Hospital Foch - Urology Service
city: Tours
country: France
facility: Centre Hospitalier Régional Universitaire de (CHRU) de Tours - Hôpital Bretonneau
city: Valenciennes
country: France
facility: CH Dentellières
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine Alexis Vautrin
city: Épagny
country: France
facility: Centre Hospitalier Annecy Genevois
city: Athens
country: Greece
facility: General Hospital of Athens Alexandra
city: Athens
country: Greece
facility: Henry Dunant Hospital
city: Chaïdári
country: Greece
facility: ATTIKO University Hospital
city: Thessaloníki
country: Greece
facility: Papageorgiou General Hosp of Thessaloniki
city: Macerata
country: Italy
facility: Ospedale Generale Provincial
city: Meldola
country: Italy
facility: Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori", IRCCS - Oncologia
city: Milano
country: Italy
facility: Fondazione IRCCS, Istituto Nazionale dei Tumori
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
city: Orbassano
country: Italy
facility: AOU San Luigi Gonzaga
city: Padova
country: Italy
facility: IOV - Istituto Oncologico Veneto - IRCCS - Ospedale Busonera
city: Pozzuoli
country: Italy
facility: P.O Santa Maria delle Grazie, ASL Napoli 2 Nord
city: Ravenna
country: Italy
facility: Ospedale "Santa Maria delle Croci" di Ravenna
city: Roma
country: Italy
facility: Ospedale San Camillo Forlanini
city: Roma
country: Italy
facility: Policlinico Universitario Campus Biomedico
city: Roma
country: Italy
facility: PU A.Gemelli, Università Cattolica del Sacro Cuore
city: Jeongnam
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul St Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Lørenskog
country: Norway
facility: Akershus Universitetssykehus
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz Medical City - Jeddah
city: Riyadh
country: Saudi Arabia
facility: King Abdulaziz Medical City- Riyadh
city: Belfast
country: United Kingdom
facility: Belfast City Hospital
city: Edinburgh
country: United Kingdom
facility: Edinburgh Cancer Centre, Western General Hospital
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: