Digital symptom monitoring for people starting cabozantinib plus nivolumab for advanced clear-cell kidney cancer
Digital Monitoring of Self-reported Symptoms by Patients Treated With Cabozantinib Plus Nivolumab for Advanced Clear-cell Renal Carcinoma: The CANIQOL Multicentre Study
This project tests whether weekly digital self-reports of symptoms can help guide treatment management for adults beginning cabozantinib plus nivolumab for advanced clear-cell kidney cancer during the first three months.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 83 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Francois Baclesse Academic / other |
| Drugs / interventions | nivolumab, cabozantinib |
| Locations | 10 sites (Annecy and 9 other locations) |
| Trial ID | NCT07028125 on ClinicalTrials.gov |
What this trial studies
Adults with advanced or metastatic clear-cell renal cell carcinoma who are beginning first-line treatment with cabozantinib plus nivolumab will use a digital system to report symptoms weekly while receiving the approved combination regimen. The digital monitoring platform collects patient-reported outcomes focused on treatment tolerance and side effects for the first three months of therapy. Clinicians will use the incoming reports to inform symptomatic management and any treatment adjustments in real-life practice. All patients receive cabozantinib and nivolumab per local labeling and physician decision prior to enrollment.
Who should consider this trial
Good fit: Adults with advanced or metastatic clear-cell renal cell carcinoma who have not had prior systemic therapy and whose doctor has already decided to start cabozantinib plus nivolumab, who can use the digital reporting tool and meet local social security and contraceptive requirements.
Not a fit: Patients who cannot use the digital system, have non–clear-cell histology, have received prior systemic therapy for RCC, or are pregnant are unlikely to benefit from this monitoring approach.
Why it matters
Potential benefit: If successful, this approach could help clinicians detect side effects earlier and adjust treatment to reduce toxicity and keep patients on effective therapy.
How similar studies have performed: Remote patient-reported outcome monitoring has improved symptom control and even survival in other metastatic cancer settings, although its use specifically with the cabozantinib plus nivolumab combination is less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Annecy and 9 other locations
- Centre Hospitalier d'Annecy — Annecy, France (Not_yet_recruiting)
- Institut Sainte Catherine — Avignon, France (Recruiting)
- Centre Hospitalier de Bayeux — Bayeux, France (Not_yet_recruiting)
- Centre François Baclesse — Caen, France (Recruiting)
- Polyclinique du Parc Elsan — Caen, France (Not_yet_recruiting)
- Ghpso Creil — Creil, France (Not_yet_recruiting)
- Centre Hospitalier de Lorient — Lorient, France (Not_yet_recruiting)
- GHR Mulhouse Sud Alsace — Mulhouse, France (Recruiting)
- Chu — Saint-Etienne, France (Not_yet_recruiting)
- Centre Hospitalier de Tours — Tours, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Florence LOBBEDEZ
- Email: f.joly@baclesse.unicancer.fr
- Phone: +33231455002
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.