Advanced Renal Cell CarcinomaCaboComboNCT05361434
A Study of the Effectiveness of Cabozantinib in Combination With Nivolumab as First-line Treatment of Advanced Renal Cell Carcinoma (aRCC) in Adults
An observational study of Advanced Renal Cell Carcinoma, run by Ipsen at 66 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Renal Cell Carcinoma
- How many people
- 311 participants
- Where
- 66 sitesin 8 countries
- Study dates
- 26 Sep 2022to 20 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
66 sites in 8 countries.
66 sites in 8 countries
France39 sites
Centre Hospitalier Universitaire (CHU) de Angers
Angers
Hopital de Mercy- CHR Metz Thionville
Ars-Laquenexy
Institut Ste Catherine - Institut du Cancer Avignon Provence
Avignon
Centre Hospitalier Régional Universitaire de Besançon - Jean Minjoz
Besançon
ICONE
Bezannes
Groupe Hospitalier Saint-André (Bordeaux)
Bordeaux
Institut Bergonié
Bordeaux
Centre Hospitalier de Boulogne-sur-mer
Boulogne-sur-Mer
Centre Hospitalier Fleyriat
Bourg-en-Bresse
Centre Finisterien de Radiotherapie et d'Oncologie
Brest
Centre d'Urologie Site Médipole - Centre Catalan d'Urologie
Cabestany
Centre de Lutte Contre le Cancer Jean PERRIN
Clermont-Ferrand
Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
Clermont-Ferrand
Centre Hospitalier Universitaire (CHU) Henri Mondor
Créteil
Centre Georges François Leclerc
Dijon
Institut de Cancérologie de Bourgogne
Dijon
Centre Hospitalier Annecy Genevois
Épagny
Centre Hospitalier intercommunal Saint Raphaël Frejus
Fréjus
Centre Hospitalier Départemental Vendée
La Roche-sur-Yon
Groupe Hospitalier De La Rochelle - Ré - Aunis
La Rochelle
Centre Hospitalier Universitaire Grenoble Alpes
La Tronche
Hôpital Privé Le Bois
Lille
Hopital Privé Jean Mermoz
Lyon
Centre Hospitalier Universitaire (CHU) de Nantes - Hôtel-Dieu
Nantes
Centre Hospitalier Régional D'orléans
Orléans
Centre Hospitalier Tenon
Paris
Hopital Bichat -Claud Bernard
Paris
Hôpital Européen Georges Pompidou (HEGP)
Paris
Hôpital Pitié-Salpétrière
Paris
Centre Hospitalier Universitaire (CHU) de Poitiers
Poitiers
CHU Charles Nicolle
Rouen
Clinique Mathilde Oncologie médicale
Rouen
Centre d'Oncologie de l'Estuaire
Saint-Nazaire
ICANS - Institut de cancérologie Strasbourg Europe
Strasbourg
Hospital Foch - Oncology Service
Suresnes
Hospital Foch - Urology Service
Suresnes
Centre Hospitalier Régional Universitaire de (CHRU) de Tours - Hôpital Bretonneau
Tours
CH Dentellières
Valenciennes
Institut de Cancérologie de Lorraine Alexis Vautrin
Vandœuvre-lès-Nancy
Italy11 sites
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori", IRCCS - Oncologia
Meldola
Fondazione IRCCS, Istituto Nazionale dei Tumori
Milan
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
Naples
AOU San Luigi Gonzaga
Orbassano
IOV - Istituto Oncologico Veneto - IRCCS - Ospedale Busonera
Padova
P.O Santa Maria delle Grazie, ASL Napoli 2 Nord
Pozzuoli
Ospedale Generale Provincial
Province of Macerata
Ospedale "Santa Maria delle Croci" di Ravenna
Ravenna
Ospedale San Camillo Forlanini
Roma
Policlinico Universitario Campus Biomedico
Roma
PU A.Gemelli, Università Cattolica del Sacro Cuore
Roma
Greece4 sites
General Hospital of Athens Alexandra
Athens
Henry Dunant Hospital
Athens
ATTIKO University Hospital
Chaïdári
Papageorgiou General Hosp of Thessaloniki
Thessaloniki
South Korea4 sites
Chonnam National University Hwasun Hospital
Jeongnam
Samsung Medical Center
Seoul
Seoul St Mary's Hospital
Seoul
Severance Hospital, Yonsei University Health System
Seoul
Belgium3 sites
CHU St Pierre & Brugmann
Brussels
Jessa Ziekenhuis
Hasselt
CHU Namur Mont-Godinne
Yvoir
Saudi Arabia2 sites
King Abdulaziz Medical City - Jeddah
Jeddah
King Abdulaziz Medical City- Riyadh
Riyadh
United Kingdom2 sites
Belfast City Hospital
Belfast
Edinburgh Cancer Centre, Western General Hospital
Edinburgh
About this study
Official title: 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.
- Conditions
- Advanced Renal Cell Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS) rate (death of any cause) from the start of cabozantinib in combination with nivolumab.
Measured: At 18 months follow up
Secondary outcomes (11)
Tumor median progression-free survival (PFS) time
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.
Measured: 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))
Assessed by the investigator
Measured: Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression
Duration of response (DOR)
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
Measured: 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)).
Measured: Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression.
Time of response (TTR)
Defined as the time between the start date of cabozantinib in combination with nivolumab and date of first response (complete or partial).
Measured: Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression
Pattern of use of cabozantinib under real-world practice conditions.
Measured: Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression
Pattern of use of nivolumab under real-world practice conditions.
Measured: Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression
Incidence of treatment-emergent Adverse Events (TEAEs) including nonserious Adverse Events (AEs), and Serious Advers Events (SAEs).
All AEs will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA) and will be classified by MedDRA PT and SOC.
Measured: Up to 42 months or disease progression
Change in disease-related symptoms
Assessed by the Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index - Disease Related Symptoms (FKSI-DRS) questionnaire
Measured: Change from baseline at each visit up to 42 months
Change in pain
Assessed by the Numerical Pain Rating Scale (NPRS)
Measured: Change from baseline at each visit up to 42 months
Percentage of participants receiving subsequent anticancer therapies following cabozantinib and nivolumab discontinuation
Including: Sequences of treatment; drug names and duration of treatment; and reason for end of treatment line
Measured: Up to 42 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start26 Sep 2022
- Primary completion20 Oct 2025
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361434
- Sponsor's protocol ID
- CLIN-60000-452
- Acronym
- CaboCombo
- Status last verified
- May 2026
- First submitted
- 29 Apr 2022
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 37403652
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational International Study of Cabozantinib Tablets in Combination With Nivolumab as First-line Treatment of Advanced Renal Cell Carcinoma in Adults
- ClinicalTrials.gov ID
- NCT05361434
- Acronym / sponsor ID
- CaboCombo / CLIN-60000-452
- Conditions
- Advanced Renal Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 4 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival (OS) rate (death of any cause) from the start of cabozantinib in combination with nivolumab.
Time frame: At 18 months follow up
11 secondary outcomes
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
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
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
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.
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
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
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
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
Change in disease-related symptoms
Time frame: Change from baseline at each visit up to 42 months
Change in pain
Time frame: Change from baseline at each visit up to 42 months
Percentage of participants receiving subsequent anticancer therapies following cabozantinib and nivolumab discontinuation
Time frame: Up to 42 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Derived from this study: PubMed 37403652Barthelemy 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.
- Individual participant dataSharing planned: Yes. 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.
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A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
66 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Renal Cell Carcinoma, run by Ipsen at 66 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in France, Italy, Greece, South Korea, Belgium and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) rate (death of any cause) from the start of cabozantinib in combination with nivolumab. (time frame: At 18 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05361434, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.