Renal Cell Carcinoma (Kidney Cancer)Phase 4CANIQOLNCT07028125
Digital Monitoring of Self-reported Symptoms by Patients Treated With Cabozantinib Plus Nivolumab for Advanced Clear-cell Renal Carcinoma
A Phase 4 study testing cabozantinib and nivolumab in people with Renal Cell Carcinoma (Kidney Cancer) and Metastatic Renal Cell Carcinoma, run by Centre Francois Baclesse at 19 sites in France.
Trial summary
The aim of the study is to evaluate the impact of digital monitoring of self-reported symptoms (PROs) on the adjustment of treatment management in patients treated with cabozantinib plus nivolumab for advanced clear cell renal cell carcinoma (RCC) in real life during the first 3 months of combined treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma (Kidney Cancer), Metastatic Renal Cell Carcinoma, Locally Advanced
- What is being tested?
- cabozantinib and nivolumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 19 sitesFrance
- Study dates
- 1 Oct 2025to Jan 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patient older than 18 years
- Diagnosis of advanced/metastatic Renal Cell Carcinoma (RCC) with a clear-cell component
- No prior systemic treatment for RCC
- Physician-initiated decision prior to study enrollment to treat with cabozantinib and nivolumab in combination, in first line for advanced/metastatic RCC, according to approved local labels
- Female subjects of childbearing potential must not be pregnant at screening and during treatment by Cabozantinib and Nivolumab. Effective methods of contraception must be used throughout the course of treatment and for at least 5 months after the end of treatment. Sexually active fertile subjects and their partners must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the study and 5 months after the last dose of study treatment, even if oral contraceptives are also used.
- Subject affiliated to an appropriate social security system
- Patient has signed informed consents obtained before any trial related activities and according to local guidelines
Who cannot join
- Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
- Current participation in another clinical study and/or in an investigational program with any intervention that could possibly interfere with the treatment and impact this study
- Patient with history of allergy or hypersensitivity to components of the study drugs
- Patient with contraindication to the study drugs
- Pregnant or lactating woman
- Patient unable to use digital tools
- Patient deprived of liberty or placed under the authority of a tutor
- Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
France19 sites, 19 recruiting
- Not yet recruiting
Centre Hospitalier d'Annecy
Annecy
Mélodie CARBONNAUX, 33450636978, mcarbonnaux@ch-annecygenevois.fr
- Recruiting
Institut Sainte Catherine
Avignon
Bertrand BILLEMONT, 33490276022, b.billemond@isc84.org
BILLEMONT
- Not yet recruiting
Centre Hospitalier de Bayeux
Bayeux
Pierre-Emmanuel BRACHET, 33231515417, pe.brachet@ch-ab.fr
BRACHET
- Not yet recruiting
CH Boulogne sur Mer
Boulogne-sur-Mer
Claire CAPELLE, MD, 0321993013, c.capelle@ch-boulogne.fr
- Recruiting
Centre François Baclesse
Caen
Romain LEVARD, MD, +33231455002, r.levard@baclesse.unicancer.fr
Romain LEVARD
- Not yet recruiting
Polyclinique du Parc Elsan
Caen
VILLEMIN, 33261676062, m.villemin@ccpc-tubiana.fr
VILLEMIN
- Not yet recruiting
Institut Andrée Dutreix
Coudekerque-Branche
Jean-Baptiste AISENFARB, MD, 03 28 28 11 07, jbaisenfarb@iadonco.org
- Not yet recruiting
Ghpso Creil
Creil
Elisabeth CAROLA, 33344616315, elisabeth.carola@ghpso.fr
CAROLA
- Not yet recruiting
Institut de cancérologie de Bourgogne
Dijon
Véronique LORGIS, MD, vlorgis@icb-cancer.fr
- Not yet recruiting
Centre Hospitalier de Lorient
Lorient
Marie L'HUISSIER, 33297069694, m.lhuissier@ghbs.bzh
Marie L'HUISSIER
- Not yet recruiting
Centre Léon Bérard
Lyon
VINCENEUX, +33 (0)4 26 55 68 42, Armelle.VINCENEUX@lyon.unicancer.fr
- Not yet recruiting
Chu Montpellier
Montpellier
Delphine TOPART, d-topart@chu-montpellier.fr
- Recruiting
GHR Mulhouse Sud Alsace
Mulhouse
Amina TABET, 33389647513, amina.tabet-zatla@ghrmsa.fr
TABET
- Not yet recruiting
Centre Antoine Lacassagne
Nice
Nicolas MARTIN, MD, 0492031000, nicolas.martin@nice.unicancer.fr
- Not yet recruiting
Chu Poitiers
Poitiers
Patrick BOUCHAERT, patrick.bouchaert@chu-poitiers.fr
- Not yet recruiting
CHU
Saint-Etienne
Pierre CORNILLON, 33477822443, pierre.cornillon@chu-st-etienne.fr
CORNILLON
- Not yet recruiting
Hôpital FOCH
Suresnes
VANO, +33 (0)1 46 25 20 78, y.vano@hopital-foch.com
- Not yet recruiting
Centre Hospitalier de Tours
Tours
Mathilde CANCEL, 33218370871
CANCEL
- Not yet recruiting
Centre d'oncologie St Yves
Vannes
Victor BASSE, 0297625534, vbasse@centre-st-yves.fr
About this study
Official title: Digital Monitoring of Self-reported Symptoms by Patients Treated With Cabozantinib Plus Nivolumab for Advanced Clear-cell Renal Carcinoma: The CANIQOL Multicentre Study
The aim of the study is to evaluate the impact of digital monitoring of self-reported symptoms (PROs) on the adjustment of treatment management in patients treated with cabozantinib plus nivolumab for advanced clear cell renal cell carcinoma (RCC) in real life during the first 3 months of combined treatment
Read the detailed description
Patients receive the combination of Cabozantinib and Nivolumab as indicated in the label.
During this combined treatment, the digital monitoring system is used to collect weekly data on treatment tolerance, based on patient reports.
- Being tested
- cabozantinib and nivolumab
- Keywords
- kidney cancer, metastatic, cabozantinib, nivolumab, digital monitoring system
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cabozantinib and nivolumabDrug
cabozantinib and nivolumab according to the labelling indication, namely:
- CABOZANTINIB 40 mg per oral route once daily
- NIVOLUMAB 240 mg per intravenous route every 2 weeks
During this combined treatment, the digital monitoring system is used to collect weekly data on treatment tolerance by patient self-report.
| Study group | Role | What they receive |
|---|---|---|
| Digital monitoring under Cabozantinib and nivolumab treatments | Experimental | During this combined treatment, the digital monitoring system is used to collect weekly data on treatment tolerance by patient self-report.
The digital telemonitoring platform is used to facilitate the monitoring of signs and symptoms of treatment-specific Adverse Events.
The platform integrates an algorithm to define patient risk based on responses to data collected on platform.
The self-reported information on the mobile digital device allows to "classify" patients ("correct", "compromised", "to be monitored", or "critical) and to create some alerts.
Some actions may be undertaken depending on these alerts, with adjustments of the management of treatments Receives: Drug: cabozantinib and nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with adjustment of treatments management
rate of patients with adjustment of treatments management including any unplanned action guided by weekly digital monitoring of self-reported symptoms: anticipated consultation, anticipated phone follow-up, anticipated advices, treatment discontinuation, hospitalization within the first 3 months of the combined treatment
Measured: within the first 3 months of the combined treatment (cabozantinib and nivolumab)
Secondary outcomes (9)
- The evolution of self-reported symptoms
report regular follow-up of self-reported symptoms on the digital platform
Measured: during the first 6 months of the combination (cabozantinb and nivolumab)
- To evaluate the improvement of self-reported symptoms after adjustment of the combined treatment
Follow-up of number of grade 3-4 of self-reported symptoms after modification of treatment management induced by remote follow-up at 3 months
Measured: during the first 3 months of the combination (cabozantinib and nivolumab)
- To characterize and evaluate regular follow-up of patients self-reported fatigue
Score of self-reported fatigue by the questionnaire Facit-F (score between 0 and 160)
Measured: During the first 6 months of combination (cabozantinib and nivolumab)
- To have a longitudinal assessment of general health-related quality of life (QoL)
- The evolution of general health-related quality of life with the score of FSKI-10 questionnaire (score between 0 and 40)
Measured: During the first 6 months of combination (cabozantinib and nivolumab)
- To assess the feasibility of regular follow-up of PROs in real life
The levels of satisfaction and difficulties encountered by patients using the digital monitoring with the French validated version of the self-questionnaire F-SUS System Usability Scale (score between 0 and 50)
Measured: At 3 and 6 months after initiation of combination (cabozantinib and nivolumab)
- To characterize and describe warning adverse reactions
- The characterization and description of warning adverse reactions that may require therapeutic adaptation
Measured: During the first 6 months of the combination (cabozantinib and nivolumab)
- To characterize alerts issued by digital monitoring
Follow-up of number of alerts issued by digital monitoring
Measured: During the first 6 months of the combination (cabozantinib and nivolumab)
To have a longitudinal assessment of anxiety/depression and pain
The evolution of anxiety/depression with HADS scale (score between 0 and 56)
Measured: During the first 6 months of combination (cabozantinib and nivolumab)
To characterize alerts issued by digital monitoring
Follow-up on the type of alerts (dose adjustment or treatment discontinuation)
Measured: During the first 6 months of combination (cabozantinib and nivolumab)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start1 Oct 2025
- Primary completionOct 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell Carcinoma (Kidney Cancer)Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028125
- Sponsor's protocol ID
- 2024-518991-30-00
- Other IDs
- 2024-518991-30-00
- Acronym
- CANIQOL
- Status last verified
- Jul 2026
- First submitted
- 10 Jun 2025
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Monitoring of Self-reported Symptoms by Patients Treated With Cabozantinib Plus Nivolumab for Advanced Clear-cell Renal Carcinoma: The CANIQOL Multicentre Study
- ClinicalTrials.gov ID
- NCT07028125
- Acronym / sponsor ID
- CANIQOL / 2024-518991-30-00
- Keywords
- kidney cancer, metastatic, cabozantinib, nivolumab, digital monitoring system
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 19 Jun 2025 (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 aim of the study is to evaluate the impact of digital monitoring of self-reported symptoms (PROs) on the adjustment of treatment management in patients treated with cabozantinib plus nivolumab for advanced clear cell renal cell carcinoma (RCC) in real life during the first 3 months of combined treatment
Detailed description
Patients receive the combination of Cabozantinib and Nivolumab as indicated in the label.
During this combined treatment, the digital monitoring system is used to collect weekly data on treatment tolerance, based on patient reports.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital monitoring under Cabozantinib and nivolumab treatments | Experimental | Drug: cabozantinib and nivolumabDuring this combined treatment, the digital monitoring system is used to collect weekly data on treatment tolerance by patient self-report. The digital telemonitoring platform is used to facilitate the monitoring of signs and symptoms of treatment-specific Adverse Events. The platform integrates an algorithm to define patient risk based on responses to data collected on platform. The self-reported information on the mobile digital device allows to "classify" patients ("correct", "compromised", "to be monitored", or "critical) and to create some alerts. Some actions may be undertaken depending on these alerts, with adjustments of the management of treatments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient older than 18 years
- Diagnosis of advanced/metastatic Renal Cell Carcinoma (RCC) with a clear-cell component
- No prior systemic treatment for RCC
- Physician-initiated decision prior to study enrollment to treat with cabozantinib and nivolumab in combination, in first line for advanced/metastatic RCC, according to approved local labels
- Female subjects of childbearing potential must not be pregnant at screening and during treatment by Cabozantinib and Nivolumab. Effective methods of contraception must be used throughout the course of treatment and for at least 5 months after the end of treatment. Sexually active fertile subjects and their partners must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the study and 5 months after the last dose of study treatment, even if oral contraceptives are also used.
Key exclusion criteria (8 listed)
- Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
- Current participation in another clinical study and/or in an investigational program with any intervention that could possibly interfere with the treatment and impact this study
- Patient with history of allergy or hypersensitivity to components of the study drugs
- Patient with contraindication to the study drugs
- Pregnant or lactating woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cabozantinib and nivolumabcabozantinib and nivolumab according to the labelling indication, namely: * CABOZANTINIB 40 mg per oral route once daily * NIVOLUMAB 240 mg per intravenous route every 2 weeks During this combined treatment, the digital monitoring system is used to collect weekly data on treatment tolerance by patient self-report. | Drug | Digital monitoring under Cabozantinib and nivolumab treatments |
Primary outcome
Rate of patients with adjustment of treatments management
Time frame: within the first 3 months of the combined treatment (cabozantinib and nivolumab)
rate of patients with adjustment of treatments management including any unplanned action guided by weekly digital monitoring of self-reported symptoms: anticipated consultation, anticipated phone follow-up, anticipated advices, treatment discontinuation, hospitalization within the first 3 months of the combined treatment
9 secondary outcomes
- The evolution of self-reported symptoms
Time frame: during the first 6 months of the combination (cabozantinb and nivolumab)
- To evaluate the improvement of self-reported symptoms after adjustment of the combined treatment
Time frame: during the first 3 months of the combination (cabozantinib and nivolumab)
- To characterize and evaluate regular follow-up of patients self-reported fatigue
Time frame: During the first 6 months of combination (cabozantinib and nivolumab)
- To have a longitudinal assessment of general health-related quality of life (QoL)
Time frame: During the first 6 months of combination (cabozantinib and nivolumab)
- To assess the feasibility of regular follow-up of PROs in real life
Time frame: At 3 and 6 months after initiation of combination (cabozantinib and nivolumab)
- To characterize and describe warning adverse reactions
Time frame: During the first 6 months of the combination (cabozantinib and nivolumab)
- To characterize alerts issued by digital monitoring
Time frame: During the first 6 months of the combination (cabozantinib and nivolumab)
To have a longitudinal assessment of anxiety/depression and pain
Time frame: During the first 6 months of combination (cabozantinib and nivolumab)
To characterize alerts issued by digital monitoring
Time frame: During the first 6 months of combination (cabozantinib and nivolumab)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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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.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cabozantinib and nivolumab in people with Renal Cell Carcinoma (Kidney Cancer) and Metastatic Renal Cell Carcinoma, run by Centre Francois Baclesse at 19 sites in France.
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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florence LOBBEDEZ (+33231455002, f.joly@baclesse.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients with adjustment of treatments management (time frame: within the first 3 months of the combined treatment (cabozantinib and nivolumab)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2026.