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

Last updated: April 30, 2025
Sponsor: Ipsen
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Carcinoma

Treatment

N/A

Clinical Study ID

NCT05361434
CLIN-60000-452
  • Ages > 18
  • All Genders

Study 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

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 locallabels;

Exclusion

Exclusion Criteria:

  • Current participation in an investigational program with any intervention whichcould possibly interfere the treatment and impact this study;

  • History of allergy or hypersensitivity to Cabometyx® or Opdivo® components.

Study Design

Total Participants: 311
Study Start date:
September 26, 2022
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • CHU St Pierre & Brugmann

    Bruxelles,
    Belgium

    Site Not Available

  • Jessa Ziekenhuis

    Hasselt,
    Belgium

    Site Not Available

  • CHU Namur Mont-Godinne

    Yvoir,
    Belgium

    Site Not Available

  • Centre Hospitalier Universitaire (CHU) de Angers

    Angers,
    France

    Site Not Available

  • Hopital de Mercy- CHR Metz Thionville

    Ars-Laquenexy,
    France

    Site Not Available

  • Institut Ste Catherine - Institut du Cancer Avignon Provence

    Avignon,
    France

    Site Not Available

  • Institut Ste Catherine - Institut du Cancer Avignon Provence Oncologie médicale

    Avignon, 84000
    France

    Site Not Available

  • Centre Hospitalier Régional Universitaire de Besançon - Jean Minjoz

    Besançon,
    France

    Site Not Available

  • ICONE

    Bezannes,
    France

    Site Not Available

  • Groupe Hospitalier Saint-André (Bordeaux)

    Bordeaux,
    France

    Site Not Available

  • Institut Bergonié

    Bordeaux,
    France

    Site Not Available

  • Centre Hospitalier de Boulogne-sur-mer

    Boulogne-sur-Mer,
    France

    Site Not Available

  • Centre Hospitalier de Boulogne-sur-mer, Service Oncologie

    Boulogne-sur-mer, 62321
    France

    Site Not Available

  • Centre Hospitalier Fleyriat

    Bourg-en-Bresse,
    France

    Site Not Available

  • Centre Finisterien de Radiotherapie et d'Oncologie

    Brest,
    France

    Site Not Available

  • Centre d'Urologie Site Médipole - Centre Catalan d'Urologie

    Cabestany,
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied

    Clermont-Ferrand,
    France

    Site Not Available

  • Centre de Lutte Contre le Cancer Jean PERRIN

    Clermont-Ferrand,
    France

    Site Not Available

  • Centre Hospitalier Universitaire (CHU) Henri Mondor

    Créteil,
    France

    Site Not Available

  • Centre Georges François Leclerc

    Dijon,
    France

    Site Not Available

  • Institut de Cancérologie de Bourgogne

    Dijon,
    France

    Site Not Available

  • Centre Hospitalier intercommunal Saint Raphaël Frejus

    Fréjus,
    France

    Site Not Available

  • Centre Hospitalier Départemental Vendée

    La Roche-sur-Yon,
    France

    Site Not Available

  • Groupe Hospitalier De La Rochelle - Ré - Aunis

    La Rochelle,
    France

    Site Not Available

  • Centre Hospitalier Universitaire Grenoble Alpes

    La Tronche,
    France

    Site Not Available

  • Hôpital Privé Le Bois

    Lille,
    France

    Site Not Available

  • Hopital Privé Jean Mermoz

    Lyon,
    France

    Site Not Available

  • Centre Hospitalier Universitaire (CHU) de Nantes - Hôtel-Dieu

    Nantes,
    France

    Site Not Available

  • Centre Hospitalier Régional D'orléans

    Orléans,
    France

    Site Not Available

  • Centre Hospitalier Régional D'orléans Hôpital de La Source

    Orléans, 45100
    France

    Site Not Available

  • Centre Hospitalier Tenon

    Paris,
    France

    Site Not Available

  • Hopital Bichat -Claud Bernard

    Paris,
    France

    Site Not Available

  • Hôpital Européen Georges Pompidou (HEGP)

    Paris,
    France

    Site Not Available

  • Hôpital Pitié-Salpétrière

    Paris,
    France

    Site Not Available

  • Centre Hospitalier Universitaire (CHU) de Poitiers

    Poitiers,
    France

    Site Not Available

  • CHU Charles Nicolle

    Rouen,
    France

    Site Not Available

  • Clinique Mathilde Oncologie médicale

    Rouen,
    France

    Site Not Available

  • Centre d'Oncologie de l'Estuaire

    Saint-Nazaire,
    France

    Site Not Available

  • ICANS - Institut de cancérologie Strasbourg Europe

    Strasbourg,
    France

    Site Not Available

  • Hospital Foch - Oncology Service

    Suresnes,
    France

    Site Not Available

  • Hospital Foch - Urology Service

    Suresnes,
    France

    Site Not Available

  • Centre Hospitalier Régional Universitaire de (CHRU) de Tours - Hôpital Bretonneau

    Tours,
    France

    Site Not Available

  • CH Dentellières

    Valenciennes,
    France

    Site Not Available

  • Institut de Cancérologie de Lorraine Alexis Vautrin

    Vandœuvre-lès-Nancy,
    France

    Site Not Available

  • Centre Hospitalier Annecy Genevois

    Épagny,
    France

    Site Not Available

  • General Hospital of Athens Alexandra

    Athens,
    Greece

    Site Not Available

  • Henry Dunant Hospital

    Athens,
    Greece

    Site Not Available

  • ATTIKO University Hospital

    Chaïdári,
    Greece

    Site Not Available

  • Papageorgiou General Hosp of Thessaloniki

    Thessaloníki,
    Greece

    Site Not Available

  • Ospedale Generale Provincial

    Macerata,
    Italy

    Site Not Available

  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori", IRCCS - Oncologia

    Meldola,
    Italy

    Site Not Available

  • Fondazione IRCCS, Istituto Nazionale dei Tumori

    Milano,
    Italy

    Site Not Available

  • Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

    Napoli,
    Italy

    Site Not Available

  • AOU San Luigi Gonzaga

    Orbassano,
    Italy

    Site Not Available

  • IOV - Istituto Oncologico Veneto - IRCCS - Ospedale Busonera

    Padova,
    Italy

    Site Not Available

  • P.O Santa Maria delle Grazie, ASL Napoli 2 Nord

    Pozzuoli,
    Italy

    Site Not Available

  • Ospedale "Santa Maria delle Croci" di Ravenna

    Ravenna,
    Italy

    Site Not Available

  • Ospedale San Camillo Forlanini

    Roma,
    Italy

    Site Not Available

  • PU A.Gemelli, Università Cattolica del Sacro Cuore

    Roma,
    Italy

    Site Not Available

  • Policlinico Universitario Campus Biomedico

    Roma,
    Italy

    Site Not Available

  • Chonnam National University Hwasun Hospital

    Jeongnam,
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Seoul St Mary's Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul,
    Korea, Republic of

    Site Not Available

  • Akershus Universitetssykehus

    Lørenskog,
    Norway

    Site Not Available

  • King Abdulaziz Medical City - Jeddah

    Jeddah,
    Saudi Arabia

    Site Not Available

  • King Abdulaziz Medical City- Riyadh

    Riyadh,
    Saudi Arabia

    Site Not Available

  • Belfast City Hospital

    Belfast,
    United Kingdom

    Site Not Available

  • Edinburgh Cancer Centre, Western General Hospital

    Edinburgh,
    United Kingdom

    Site Not Available

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