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

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Description

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.

Study Overview

Start Date
September 26, 2022
Completion Date
November 30, 2026
Enrollment
311
Date Posted
May 4, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Centre Hospitalier Universitaire (CHU) de Angers
Angers, France

Centre Hospitalier Régional Universitaire de Besançon - Jean Minjoz
Besançon, France

Groupe Hospitalier Saint-André (Bordeaux)
Bordeaux, France

Institut Bergonié
Bordeaux, 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 Départemental Vendée
La Roche-sur-Yon, France

Centre Hospitalier Universitaire Grenoble Alpes
La Tronche, France

Hôpital Privé Le Bois
Lille, France

Centre Hospitalier Universitaire (CHU) de Nantes - Hôtel-Dieu
Nantes, France

Centre Hospitalier Régional D'orléans
Orléans, France

Centre Hospitalier Universitaire (CHU) de Poitiers
Poitiers, 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

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 Nazionale Tumori IRCCS "Fondazione G. Pascale"
Napoli, 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

PU A.Gemelli, Università Cattolica del Sacro Cuore
Roma, Italy

Samsung Medical Center
Seoul, Korea, Republic of

King Abdulaziz Medical City- Riyadh
Riyadh, Saudi Arabia

Belfast City Hospital
Belfast, United Kingdom

Eligibility

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
Minimum Age (years)
18
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.

Study Contact Info

Study Contact Name
Ipsen Recruitment Enquiries
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT05361434