A Study of the Effectiveness of Cabozantinib in Combination With Nivolumab as First-line Treatment of Advanced Renal Cell Carcinoma (aRCC) in Adults
- Conditions
- Advanced Renal Cell Carcinoma
- Registration Number
- NCT05361434
- Lead Sponsor
- Ipsen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 311
- 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;
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival (OS) rate (death of any cause) from the start of cabozantinib in combination with nivolumab. At 18 months follow up
- Secondary Outcome Measures
Name Time Method Proportion of participants who achieve complete response, partial response or stable disease (Disease Control Rate (DCR)). Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression. Incidence of treatment-emergent Adverse Events (TEAEs) including nonserious Adverse Events (AEs), and Serious Advers Events (SAEs). Up to 42 months or disease progression All AEs will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA) and will be classified by MedDRA PT and SOC.
Change in pain Change from baseline at each visit up to 42 months Assessed by the Numerical Pain Rating Scale (NPRS)
Duration of response (DOR) Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression Defined as the interval from the date of first response (complete or partial) to treatment with cabozantinib in combination with nivolumab, to progressive disease or death
Time of response (TTR) Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression Defined as the time between the start date of cabozantinib in combination with nivolumab and date of first response (complete or partial).
Pattern of use of nivolumab under real-world practice conditions. Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression Tumor median progression-free survival (PFS) time Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression Including clinical and radiographic assessments defined as the time between the start date of cabozantinib in combination with nivolumab and the date of progression or death of any cause. The Kaplan-Meier method will be used to estimate median PFS.
Proportion of participants who achieve partial or complete response (Objective Response Rate (ORR)) Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression Assessed by the investigator
Pattern of use of cabozantinib under real-world practice conditions. Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression Change in disease-related symptoms Change from baseline at each visit up to 42 months Assessed by the Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index - Disease Related Symptoms (FKSI-DRS) questionnaire
Percentage of participants receiving subsequent anticancer therapies following cabozantinib and nivolumab discontinuation Up to 42 months. Including: Sequences of treatment; drug names and duration of treatment; and reason for end of treatment line
Trial Locations
- Locations (66)
CHU St Pierre & Brugmann
🇧🇪Bruxelles, Belgium
Jessa Ziekenhuis
🇧🇪Hasselt, Belgium
CHU Namur Mont-Godinne
🇧🇪Yvoir, Belgium
Centre Hospitalier Universitaire (CHU) de Angers
🇫🇷Angers, France
Hopital de Mercy- CHR Metz Thionville
🇫🇷Ars-Laquenexy, France
Institut Ste Catherine - Institut du Cancer Avignon Provence
🇫🇷Avignon, France
Centre Hospitalier Régional Universitaire de Besançon - Jean Minjoz
🇫🇷Besançon, France
ICONE
🇫🇷Bezannes, France
Groupe Hospitalier Saint-André (Bordeaux)
🇫🇷Bordeaux, France
Institut Bergonié
🇫🇷Bordeaux, France
Centre Hospitalier de Boulogne-sur-mer
🇫🇷Boulogne-sur-Mer, France
Centre Hospitalier Fleyriat
🇫🇷Bourg-en-Bresse, France
Centre Finisterien de Radiotherapie et d'Oncologie
🇫🇷Brest, France
Centre d'Urologie Site Médipole - Centre Catalan d'Urologie
🇫🇷Cabestany, France
Centre de Lutte Contre le Cancer Jean PERRIN
🇫🇷Clermont-Ferrand, France
Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
🇫🇷Clermont-Ferrand, France
Centre Hospitalier Universitaire (CHU) Henri Mondor
🇫🇷Créteil, France
Centre Georges François Leclerc
🇫🇷Dijon, France
Institut de Cancérologie de Bourgogne
🇫🇷Dijon, France
Centre Hospitalier intercommunal Saint Raphaël Frejus
🇫🇷Fréjus, France
Centre Hospitalier Départemental Vendée
🇫🇷La Roche-sur-Yon, France
Groupe Hospitalier De La Rochelle - Ré - Aunis
🇫🇷La Rochelle, France
Centre Hospitalier Universitaire Grenoble Alpes
🇫🇷La Tronche, France
Hôpital Privé Le Bois
🇫🇷Lille, France
Hopital Privé Jean Mermoz
🇫🇷Lyon, France
Centre Hospitalier Universitaire (CHU) de Nantes - Hôtel-Dieu
🇫🇷Nantes, France
Centre Hospitalier Régional D'orléans
🇫🇷Orléans, France
Centre Hospitalier Tenon
🇫🇷Paris, France
Hopital Bichat -Claud Bernard
🇫🇷Paris, France
Hôpital Européen Georges Pompidou (HEGP)
🇫🇷Paris, France
Hôpital Pitié-Salpétrière
🇫🇷Paris, France
Centre Hospitalier Universitaire (CHU) de Poitiers
🇫🇷Poitiers, France
CHU Charles Nicolle
🇫🇷Rouen, France
Clinique Mathilde Oncologie médicale
🇫🇷Rouen, France
Centre d'Oncologie de l'Estuaire
🇫🇷Saint-Nazaire, France
ICANS - Institut de cancérologie Strasbourg Europe
🇫🇷Strasbourg, France
Hospital Foch - Oncology Service
🇫🇷Suresnes, France
Hospital Foch - Urology Service
🇫🇷Suresnes, France
Centre Hospitalier Régional Universitaire de (CHRU) de Tours - Hôpital Bretonneau
🇫🇷Tours, France
CH Dentellières
🇫🇷Valenciennes, France
Institut de Cancérologie de Lorraine Alexis Vautrin
🇫🇷Vandœuvre-lès-Nancy, France
Centre Hospitalier Annecy Genevois
🇫🇷Épagny, France
General Hospital of Athens Alexandra
🇬🇷Athens, Greece
Henry Dunant Hospital
🇬🇷Athens, Greece
ATTIKO University Hospital
🇬🇷Chaïdári, Greece
Papageorgiou General Hosp of Thessaloniki
🇬🇷Thessaloníki, Greece
Ospedale Generale Provincial
🇮🇹Macerata, Italy
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori", IRCCS - Oncologia
🇮🇹Meldola, Italy
Fondazione IRCCS, Istituto Nazionale dei Tumori
🇮🇹Milano, Italy
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
🇮🇹Napoli, Italy
AOU San Luigi Gonzaga
🇮🇹Orbassano, Italy
IOV - Istituto Oncologico Veneto - IRCCS - Ospedale Busonera
🇮🇹Padova, Italy
P.O Santa Maria delle Grazie, ASL Napoli 2 Nord
🇮🇹Pozzuoli, Italy
Ospedale "Santa Maria delle Croci" di Ravenna
🇮🇹Ravenna, Italy
Ospedale San Camillo Forlanini
🇮🇹Roma, Italy
Policlinico Universitario Campus Biomedico
🇮🇹Roma, Italy
PU A.Gemelli, Università Cattolica del Sacro Cuore
🇮🇹Roma, Italy
Chonnam National University Hwasun Hospital
🇰🇷Jeongnam, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul St Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Akershus Universitetssykehus
🇳🇴Lørenskog, Norway
King Abdulaziz Medical City - Jeddah
🇸🇦Jeddah, Saudi Arabia
King Abdulaziz Medical City- Riyadh
🇸🇦Riyadh, Saudi Arabia
Belfast City Hospital
🇬🇧Belfast, United Kingdom
Edinburgh Cancer Centre, Western General Hospital
🇬🇧Edinburgh, United Kingdom