Digital Symptom Monitoring in Advanced Kidney Cancer Treated With Cabozantinib and Nivolumab
Tests digital tracking of self-reported symptoms in adults with advanced clear-cell kidney cancer.
Plain-language title generated from the registry record
Registry title: Digital Monitoring of Self-reported Symptoms by Patients Treated With Cabozantinib Plus Nivolumab for Advanced Clear-cell Renal Carcinoma
Key facts
- Where
- Avignon, Bayeux, Boulogne-sur-Mer, Caen, Caen Cedex 5, Coudekerque-Branche, Creil, Dijon, Epagny Metz-tessy, Lorient, Lyon, Montpellier Cedex 5, Mulhouse, Nice Cedex 2, Poitiers, St Etienne Cedex 2, Suresnes, Tours, and Vannes, FranceSee the 19 sites
- Phase
- Phase 4
Where in France
- Institut Sainte-CatherineAvignon, FranceTaking people
- Centre Hospitalier Aunay-BayeuxBayeux, FranceTaking people
- Centre Hospitalier de Boulogne-Sur-MerBoulogne-sur-Mer, FranceTaking people
- Polyclinique du ParcCaen, FranceTaking people
- Centre Francois BaclesseCaen Cedex 5, FranceTaking people
- Clinique de FlandreCoudekerque-Branche, FranceTaking people
- Groupe Hospitalier Public Du Sud De L OiseCreil, FranceTaking people
- Institut de Cancérologie de BourgogneDijon, FranceTaking people
- Centre Hospitalier Annecy GenevoisEpagny Metz-tessy, FranceTaking people
- Groupe Hospitalier Bretagne SudLorient, FranceTaking people
- Centre Leon BerardLyon, FranceTaking people
- Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5, FranceTaking people
- Groupe Hospitalier de la Région de Mulhouse et Sud AlsaceMulhouse, FranceTaking people
- Centre Antoine LacassagneNice Cedex 2, FranceTaking people
- Centre Hospitalier Universitaire de PoitiersPoitiers, FranceTaking people
- Centre Hospitalier Universitaire De Saint EtienneSt Etienne Cedex 2, FranceTaking people
- Hospital FochSuresnes, FranceTaking people
- Centre Hospitalier Régional Universitaire de ToursTours, FranceTaking people
- Centre d'Oncologie Saint-YvesVannes, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre Francois Baclesse
- Trial code
- NCT07028125EU 2024-518991-30-00
- Record updated
- 14 July 2026
- Original description
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 treatmentRead full original descriptionShow less
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
Inclusion: 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: Patient with contraindication to the study drugs; Patient with history of allergy or hypersensitivity to components of the study drugs; 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; 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.