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

NCT ID: NCT05361434

Last Updated: 2026-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

311 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-26

Study Completion Date

2026-11-30

Brief Summary

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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

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Conditions

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Advanced Renal Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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CHU St Pierre & Brugmann

Brussels, , Belgium

Site Status

Jessa Ziekenhuis

Hasselt, , Belgium

Site Status

CHU Namur Mont-Godinne

Yvoir, , Belgium

Site Status

Centre Hospitalier Universitaire (CHU) de Angers

Angers, , France

Site Status

Hopital de Mercy- CHR Metz Thionville

Ars-Laquenexy, , France

Site Status

Institut Ste Catherine - Institut du Cancer Avignon Provence

Avignon, , France

Site Status

Centre Hospitalier Régional Universitaire de Besançon - Jean Minjoz

Besançon, , France

Site Status

ICONE

Bezannes, , France

Site Status

Groupe Hospitalier Saint-André (Bordeaux)

Bordeaux, , France

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Institut Bergonié

Bordeaux, , France

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Centre Hospitalier de Boulogne-sur-mer

Boulogne-sur-Mer, , France

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Centre Hospitalier Fleyriat

Bourg-en-Bresse, , France

Site Status

Centre Finisterien de Radiotherapie et d'Oncologie

Brest, , France

Site Status

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

Cabestany, , France

Site Status

Centre de Lutte Contre le Cancer Jean PERRIN

Clermont-Ferrand, , France

Site Status

Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied

Clermont-Ferrand, , France

Site Status

Centre Hospitalier Universitaire (CHU) Henri Mondor

Créteil, , France

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Centre Georges François Leclerc

Dijon, , France

Site Status

Institut de Cancérologie de Bourgogne

Dijon, , France

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Centre Hospitalier Annecy Genevois

Épagny, , France

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Centre Hospitalier intercommunal Saint Raphaël Frejus

Fréjus, , France

Site Status

Centre Hospitalier Départemental Vendée

La Roche-sur-Yon, , France

Site Status

Groupe Hospitalier De La Rochelle - Ré - Aunis

La Rochelle, , France

Site Status

Centre Hospitalier Universitaire Grenoble Alpes

La Tronche, , France

Site Status

Hôpital Privé Le Bois

Lille, , France

Site Status

Hopital Privé Jean Mermoz

Lyon, , France

Site Status

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

Nantes, , France

Site Status

Centre Hospitalier Régional D'orléans

Orléans, , France

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Centre Hospitalier Tenon

Paris, , France

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Hopital Bichat -Claud Bernard

Paris, , France

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Hôpital Européen Georges Pompidou (HEGP)

Paris, , France

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Hôpital Pitié-Salpétrière

Paris, , France

Site Status

Centre Hospitalier Universitaire (CHU) de Poitiers

Poitiers, , France

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CHU Charles Nicolle

Rouen, , France

Site Status

Clinique Mathilde Oncologie médicale

Rouen, , France

Site Status

Centre d'Oncologie de l'Estuaire

Saint-Nazaire, , France

Site Status

ICANS - Institut de cancérologie Strasbourg Europe

Strasbourg, , France

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Hospital Foch - Oncology Service

Suresnes, , France

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Hospital Foch - Urology Service

Suresnes, , France

Site Status

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

Tours, , France

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CH Dentellières

Valenciennes, , France

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Institut de Cancérologie de Lorraine Alexis Vautrin

Vandœuvre-lès-Nancy, , France

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General Hospital of Athens Alexandra

Athens, , Greece

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Henry Dunant Hospital

Athens, , Greece

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ATTIKO University Hospital

Chaïdári, , Greece

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Papageorgiou General Hosp of Thessaloniki

Thessaloniki, , Greece

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Ospedale Generale Provincial

Macerata, , Italy

Site Status

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

Meldola, , Italy

Site Status

Fondazione IRCCS, Istituto Nazionale dei Tumori

Milan, , Italy

Site Status

Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

Napoli, , Italy

Site Status

AOU San Luigi Gonzaga

Orbassano, , Italy

Site Status

IOV - Istituto Oncologico Veneto - IRCCS - Ospedale Busonera

Padua, , Italy

Site Status

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

Pozzuoli, , Italy

Site Status

Ospedale "Santa Maria delle Croci" di Ravenna

Ravenna, , Italy

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Ospedale San Camillo Forlanini

Roma, , Italy

Site Status

Policlinico Universitario Campus Biomedico

Roma, , Italy

Site Status

PU A.Gemelli, Università Cattolica del Sacro Cuore

Roma, , Italy

Site Status

Akershus Universitetssykehus

Lørenskog, , Norway

Site Status

King Abdulaziz Medical City - Jeddah

Jeddah, , Saudi Arabia

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King Abdulaziz Medical City- Riyadh

Riyadh, , Saudi Arabia

Site Status

Chonnam National University Hwasun Hospital

Jeongnam, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Seoul St Mary's Hospital

Seoul, , South Korea

Site Status

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status

Belfast City Hospital

Belfast, , United Kingdom

Site Status

Edinburgh Cancer Centre, Western General Hospital

Edinburgh, , United Kingdom

Site Status

Countries

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Belgium France Greece Italy Norway Saudi Arabia South Korea United Kingdom

References

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Barthelemy P, Dutailly P, Qvick B, Perrot V, Verzoni E. CaboCombo: a prospective, phase IV study of first-line cabozantinib + nivolumab for advanced renal cell carcinoma. Future Oncol. 2024 Apr;20(13):811-819. doi: 10.2217/fon-2023-0353. Epub 2023 Jul 5.

Reference Type DERIVED
PMID: 37403652 (View on PubMed)

Other Identifiers

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CLIN-60000-452

Identifier Type: -

Identifier Source: org_study_id

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