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NCT Number: NCT07028125

Digital Monitoring of Self-reported Symptoms by Patients Treated With Cabozantinib Plus Nivolumab for Advanced Clear-cell Renal Carcinoma

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

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Key information

Conditions

Renal Cell Carcinoma (Kidney Cancer) Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Locally Advanced Male Urogenital Diseases Metastatic Renal Cell Carcinoma Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre Hospitalier d'Annecy, Annecy, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

cabozantinib and nivolumab

Drug

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. - The evolution of self-reported symptoms

    Time frame: during the first 6 months of the combination (cabozantinb and nivolumab)

    report regular follow-up of self-reported symptoms on the digital platform

  2. - 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)

    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

  3. - To characterize and evaluate regular follow-up of patients self-reported fatigue

    Time frame: During the first 6 months of combination (cabozantinib and nivolumab)

    Score of self-reported fatigue by the questionnaire Facit-F (score between 0 and 160)

  4. - 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)

    • The evolution of general health-related quality of life with the score of FSKI-10 questionnaire (score between 0 and 40)

  5. - 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)

    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)

  6. - To characterize and describe warning adverse reactions

    Time frame: During the first 6 months of the combination (cabozantinib and nivolumab)

    • The characterization and description of warning adverse reactions that may require therapeutic adaptation

  7. - To characterize alerts issued by digital monitoring

    Time frame: During the first 6 months of the combination (cabozantinib and nivolumab)

    Follow-up of number of alerts issued by digital monitoring

  8. To have a longitudinal assessment of anxiety/depression and pain

    Time frame: During the first 6 months of combination (cabozantinib and nivolumab)

    The evolution of anxiety/depression with HADS scale (score between 0 and 56)

  9. To characterize alerts issued by digital monitoring

    Time frame: During the first 6 months of combination (cabozantinib and nivolumab)

    Follow-up on the type of alerts (dose adjustment or treatment discontinuation)

Study contacts

Contact information is provided by the study sponsor or research team.

Florence LOBBEDEZ

CONTACT

[email protected]

+33231455002

Romain LEVARD, MD

CONTACT

[email protected]

+33231455002

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Registry information

Official study title

Digital Monitoring of Self-reported Symptoms by Patients Treated With Cabozantinib Plus Nivolumab for Advanced Clear-cell Renal Carcinoma: The CANIQOL Multicentre Study

Acronym: CANIQOL

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jun 19, 2025
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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