A Study of the Effectiveness of Cabozantinib in Combination With Nivolumab as First-line Treatment of Advanced Renal Cell Carcinoma (aRCC) in Adults
CaboCombo
A Prospective Observational International Study of Cabozantinib Tablets in Combination With Nivolumab as First-line Treatment of Advanced Renal Cell Carcinoma in Adults
1 other identifier
observational
311
8 countries
66
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2022
Longer than P75 for all trials
66 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2022
CompletedFirst Posted
Study publicly available on registry
May 4, 2022
CompletedStudy Start
First participant enrolled
September 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2026
ExpectedApril 30, 2026
April 1, 2026
3.1 years
April 29, 2022
April 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival (OS) rate (death of any cause) from the start of cabozantinib in combination with nivolumab.
At 18 months follow up
Secondary Outcomes (11)
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
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
Duration of response (DOR)
Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression
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.
Time of response (TTR)
Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression
- +6 more secondary outcomes
Eligibility Criteria
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
You may qualify if:
- 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;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (66)
CHU St Pierre & Brugmann
Brussels, 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 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, France
General Hospital of Athens Alexandra
Athens, Greece
Henry Dunant Hospital
Athens, Greece
ATTIKO University Hospital
Chaïdári, Greece
Papageorgiou General Hosp of Thessaloniki
Thessaloniki, 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
Milan, Italy
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
Naples, 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
Akershus Universitetssykehus
Lørenskog, Norway
King Abdulaziz Medical City - Jeddah
Jeddah, Saudi Arabia
King Abdulaziz Medical City- Riyadh
Riyadh, Saudi Arabia
Chonnam National University Hwasun Hospital
Jeongnam, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul St Mary's Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Belfast City Hospital
Belfast, United Kingdom
Edinburgh Cancer Centre, Western General Hospital
Edinburgh, United Kingdom
Related Publications (1)
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.
PMID: 37403652DERIVED
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2022
First Posted
May 4, 2022
Study Start
September 26, 2022
Primary Completion
October 20, 2025
Study Completion (Estimated)
November 30, 2026
Last Updated
April 30, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.
- Access Criteria
- Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.