A Study of the Effectiveness of Cabozantinib in Combination With Nivolumab as First-line Treatment of Advanced Renal Cell Carcinoma (aRCC) in Adults

Advanced Renal Cell Carcinoma Clinical Trial

— CaboCombo  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05361434
• Other study ID #: CLIN-60000-452
• Status: Recruiting
• Start date: September 26, 2022
• Est. completion date: November 30, 2026

Study information

• Verified date: April 2024
• Source: Ipsen
• Contact: Ipsen Recruitment Enquiries
• Phone: see email
• Email: clinical.trials[@]ipsen.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 311
• Est. completion date: November 30, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Renal Cell Carcinoma
• Carcinoma
• Carcinoma, Renal Cell

Locations

Country	Name	City	State
Belgium	CHU St Pierre & Brugmann	Bruxelles
Belgium	Jessa Ziekenhuis	Hasselt
Belgium	CHU Namur Mont-Godinne	Yvoir
France	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 Annecy Genevois	Épagny
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
Greece	General Hospital of Athens Alexandra	Athens
Greece	Henry Dunant Hospital	Athens
Greece	ATTIKO University Hospital	Chaïdári
Greece	Papageorgiou General Hosp of Thessaloniki	Thessaloníki
Italy	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
Korea, Republic of	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
Norway	Akershus Universitetssykehus	Lørenskog
Saudi Arabia	King Abdulaziz Medical City - Jeddah	Jeddah
Saudi Arabia	King Abdulaziz Medical City- Riyadh	Riyadh
United Kingdom	Belfast City Hospital	Belfast
United Kingdom	Edinburgh Cancer Centre, Western General Hospital	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

Belgium,  France,  Greece,  Italy,  Korea, Republic of,  Norway,  Saudi Arabia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS) rate (death of any cause) from the start of cabozantinib in combination with nivolumab.		At 18 months follow up
Secondary	Tumor median progression-free survival (PFS) time	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.	Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression
Secondary	Proportion of participants who achieve partial or complete response (Objective Response Rate (ORR))	Assessed by the investigator	Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression
Secondary	Duration of response (DOR)	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	Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression
Secondary	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.
Secondary	Time of response (TTR)	Defined as the time between the start date of cabozantinib in combination with nivolumab and date of first response (complete or partial).	Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression
Secondary	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
Secondary	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
Secondary	Incidence of treatment-emergent Adverse Events (TEAEs) including nonserious Adverse Events (AEs), and Serious Advers Events (SAEs).	All AEs will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA) and will be classified by MedDRA PT and SOC.	Up to 42 months or disease progression
Secondary	Change in disease-related symptoms	Assessed by the Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index - Disease Related Symptoms (FKSI-DRS) questionnaire	Change from baseline at each visit up to 42 months
Secondary	Change in pain	Assessed by the Numerical Pain Rating Scale (NPRS)	Change from baseline at each visit up to 42 months
Secondary	Percentage of participants receiving subsequent anticancer therapies following cabozantinib and nivolumab discontinuation	Including: Sequences of treatment; drug names and duration of treatment; and reason for end of treatment line	Up to 42 months.