A Study of the Effectiveness of Cabozantinib in Combination With Nivolumab as First-line Treatment of Advanced Renal Cell Carcinoma (aRCC) in Adults (CaboCombo)
May 29, 2026 updated by: Ipsen
A Prospective Observational International Study of Cabozantinib Tablets in Combination With Nivolumab as First-line Treatment of Advanced Renal Cell Carcinoma in Adults
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
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
311
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Brussels, Belgium
- CHU St Pierre & Brugmann
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Hasselt, Belgium
- Jessa Ziekenhuis
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Yvoir, Belgium
- CHU Namur Mont-Godinne
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Angers, France
- Centre Hospitalier Universitaire (CHU) de Angers
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Ars-Laquenexy, France
- Hopital de Mercy- CHR Metz Thionville
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Avignon, France
- Institut Ste Catherine - Institut du Cancer Avignon Provence
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Besançon, France
- Centre Hospitalier Régional Universitaire de Besançon - Jean Minjoz
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Bezannes, France
- ICONE
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Bordeaux, France
- Institut Bergonie
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Bordeaux, France
- Groupe Hospitalier Saint-André (Bordeaux)
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Boulogne-sur-Mer, France
- Centre Hospitalier de Boulogne-Sur-Mer
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Bourg-en-Bresse, France
- Centre hospitalier Fleyriat
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Brest, France
- Centre Finisterien de Radiotherapie et d'Oncologie
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Cabestany, France
- Centre d'Urologie Site Médipole - Centre Catalan d'Urologie
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Clermont-Ferrand, France
- Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
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Clermont-Ferrand, France
- Centre de Lutte Contre le Cancer Jean Perrin
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Créteil, France
- Centre Hospitalier Universitaire (CHU) Henri Mondor
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Dijon, France
- Centre Georges François Leclerc
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Dijon, France
- Institut de Cancerologie de Bourgogne
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Fréjus, France
- Centre Hospitalier intercommunal Saint Raphaël Frejus
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La Roche-sur-Yon, France
- Centre Hospitalier Departemental Vendee
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La Rochelle, France
- Groupe Hospitalier De La Rochelle - Ré - Aunis
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La Tronche, France
- Centre Hospitalier Universitaire Grenoble Alpes
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Lille, France
- Hopital prive Le Bois
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Lyon, France
- Hôpital privé Jean Mermoz
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Nantes, France
- Centre Hospitalier Universitaire (CHU) de Nantes - Hôtel-Dieu
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Orléans, France
- Centre Hospitalier Régional d'Orléans
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Paris, France
- Hôpital Pitié-Salpêtrière
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Paris, France
- Hôpital Européen Georges Pompidou (HEGP)
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Paris, France
- Centre Hospitalier Tenon
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Paris, France
- Hopital Bichat -Claud Bernard
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Poitiers, France
- Centre Hospitalier Universitaire (CHU) de Poitiers
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Rouen, France
- CHU Charles Nicolle
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Rouen, France
- Clinique Mathilde Oncologie médicale
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Saint-Nazaire, France
- Centre d'Oncologie de l'Estuaire
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Strasbourg, France
- ICANS - Institut de cancérologie Strasbourg Europe
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Suresnes, France
- Hospital Foch - Oncology Service
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Suresnes, France
- Hospital Foch - Urology Service
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Tours, France
- Centre Hospitalier Régional Universitaire de (CHRU) de Tours - Hôpital Bretonneau
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Valenciennes, France
- CH Dentellières
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Vandœuvre-lès-Nancy, France
- Institut de Cancérologie de Lorraine ALEXIS VAUTRIN
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Épagny, France
- Centre Hospitalier Annecy Genevois
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Athens, Greece
- General Hospital of Athens Alexandra
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Athens, Greece
- Henry Dunant hospital
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Chaïdári, Greece
- ATTIKO University Hospital
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Thessaloniki, Greece
- Papageorgiou General Hosp of Thessaloniki
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Meldola, Italy
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori", IRCCS - Oncologia
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Milan, Italy
- Fondazione IRCCS, Istituto Nazionale dei Tumori
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Naples, Italy
- Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
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Orbassano, Italy
- AOU San Luigi Gonzaga
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Padova, Italy
- IOV - Istituto Oncologico Veneto - IRCCS - Ospedale Busonera
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Pozzuoli, Italy
- P.O Santa Maria delle Grazie, ASL Napoli 2 Nord
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Province of Macerata, Italy
- Ospedale Generale Provincial
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Ravenna, Italy
- Ospedale "Santa Maria delle Croci" di Ravenna
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Roma, Italy
- Policlinico Universitario Campus Biomedico
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Roma, Italy
- Ospedale San Camillo Forlanini
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Roma, Italy
- PU A.Gemelli, Università Cattolica del Sacro Cuore
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Lørenskog, Norway
- Akershus universitetssykehus
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Jeddah, Saudi Arabia
- King Abdulaziz Medical City - Jeddah
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Riyadh, Saudi Arabia
- King Abdulaziz Medical City- Riyadh
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Jeongnam, South Korea
- Chonnam National University Hwasun Hospital
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Seoul, South Korea
- Samsung Medical Center
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Seoul, South Korea
- Seoul St Mary's Hospital
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Seoul, South Korea
- Severance Hospital, Yonsei University Health System
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Belfast, United Kingdom
- Belfast City Hospital
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Edinburgh, United Kingdom
- Edinburgh Cancer Centre, Western General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
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
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Overall survival (OS) rate (death of any cause) from the start of cabozantinib in combination with nivolumab.
Time Frame: At 18 months follow up
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At 18 months follow up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Tumor median progression-free survival (PFS) time
Time Frame: Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression
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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.
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Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression
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Proportion of participants who achieve partial or complete response (Objective Response Rate (ORR))
Time Frame: Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression
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Assessed by the investigator
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Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression
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Duration of response (DOR)
Time Frame: Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression
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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
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Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression
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Proportion of participants who achieve complete response, partial response or stable disease (Disease Control Rate (DCR)).
Time Frame: Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression.
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Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression.
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Time of response (TTR)
Time Frame: Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression
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Defined as the time between the start date of cabozantinib in combination with nivolumab and date of first response (complete or partial).
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Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression
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Pattern of use of cabozantinib under real-world practice conditions.
Time Frame: Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression
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Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression
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Pattern of use of nivolumab under real-world practice conditions.
Time Frame: Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression
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Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression
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Incidence of treatment-emergent Adverse Events (TEAEs) including nonserious Adverse Events (AEs), and Serious Advers Events (SAEs).
Time Frame: Up to 42 months or disease progression
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All AEs will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA) and will be classified by MedDRA PT and SOC.
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Up to 42 months or disease progression
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Change in disease-related symptoms
Time Frame: Change from baseline at each visit up to 42 months
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Assessed by the Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index - Disease Related Symptoms (FKSI-DRS) questionnaire
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Change from baseline at each visit up to 42 months
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Change in pain
Time Frame: Change from baseline at each visit up to 42 months
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Assessed by the Numerical Pain Rating Scale (NPRS)
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Change from baseline at each visit up to 42 months
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Percentage of participants receiving subsequent anticancer therapies following cabozantinib and nivolumab discontinuation
Time Frame: Up to 42 months.
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Including: Sequences of treatment; drug names and duration of treatment; and reason for end of treatment line
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Up to 42 months.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Ipsen Medical Director, Ipsen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 26, 2022
Primary Completion (Actual)
October 20, 2025
Study Completion (Actual)
October 20, 2025
Study Registration Dates
First Submitted
April 29, 2022
First Submitted That Met QC Criteria
April 29, 2022
First Posted (Actual)
May 4, 2022
Study Record Updates
Last Update Posted (Actual)
June 1, 2026
Last Update Submitted That Met QC Criteria
May 29, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Neoplasms by Histologic Type
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Urologic Neoplasms
- Kidney Neoplasms
- Carcinoma
- Carcinoma, Renal Cell
Other Study ID Numbers
- CLIN-60000-452
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing 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.
IPD Sharing 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/).
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.