Digital monitoring of self-reported symptoms by patients treated with Cabozantinib plus Nivolumab for advanced clear-cell renal carcinoma: The CANIQOL multicentre study

Phase 4

Not yet recruiting

• Conditions: kidney cancer

• Registration Number: 2024-518991-30-00
• Lead Sponsor: Centre Francois Baclesse

Brief Summary

To evaluate the impact of digital monitoring of self-reported symptoms (PROs-CTC-AEs) to adjust treatments management of patients treated with cabozantinib plus nivolumab for advanced clear-cell RCC in real life during the first 3 months of the combined treatment

Detailed Description

Not available

Study Timeline

• Study First Posted: 2025-06-04
• Last Update Posted: 2025-06-04

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 83

Inclusion Criteria

Patient older than 18 years

Diagnosis of 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, according to approved local labels

Subjects 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

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the adjustment of treatments management including any unplanned action guided by weekly digital monitoring of PRO-CTCAEs: anticipated consultation, anticipated phone follow-up, anticipated advices, treatment discontinuation, hospitalization within the first 3 months of the combined treatment		The primary endpoint is the adjustment of treatments management including any unplanned action guided by weekly digital monitoring of PRO-CTCAEs: anticipated consultation, anticipated phone follow-up, anticipated advices, treatment discontinuation, hospitalization within the first 3 months of the combined treatment

Trial Locations

Locations (10)

Centre Hospitalier Regional Universitaire De Tours; 🇫🇷 Tours, France

Institut Sainte Catherine; 🇫🇷 Avignon, France

Centre Hospitalier Annecy Genevois; 🇫🇷 Epagny Metz Tessy, France

Centre Hospitalier Universitaire De Saint Etienne; 🇫🇷 St Etienne Cedex 2, France

Polyclinique du Parc; 🇫🇷 Caen, France

Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace; 🇫🇷 Mulhouse, France

Groupe Hospitalier Bretagne Sud; 🇫🇷 Lorient, France

Centre Francois Baclesse; 🇫🇷 Caen Cedex 5, France

Groupe Hospitalier Public Du Sud De L Oise; 🇫🇷 Creil, France

Centre Hospitalier Aunay Bayeux; 🇫🇷 Bayeux, France

Centre Hospitalier Regional Universitaire De Tours

🇫🇷Tours, France

Mathilde CANCEL

Site contact

0218370871

m.cancel@chu-tours.fr