Digital symptom monitoring for people starting cabozantinib plus nivolumab for advanced clear-cell kidney cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Institut Sainte Catherine
  Avignon, France Recruiting
• Centre François Baclesse
  Caen, France Recruiting
• GHR Mulhouse Sud Alsace
  Mulhouse, France Recruiting
• Centre Hospitalier d'Annecy
  Annecy, France Not yet recruiting
• Centre Hospitalier de Bayeux
  Bayeux, France Not yet recruiting
• CH Boulogne sur Mer
  Boulogne-sur-Mer, France Not yet recruiting

Study contacts

• Study coordinator: Florence LOBBEDEZ
• Email: f.joly@baclesse.unicancer.fr
• Phone: +33231455002

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Combination treatment for advanced clear cell kidney cancer

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• Alternative dosing schedule for cabozantinib in advanced kidney and neuroendocrine tumors

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• Combining cabozantinib and nivolumab to treat advanced melanoma and head and neck cancer

  This study is testing a combination of two cancer drugs, cabozantinib and nivolumab, to see if they can help people with advanced melanoma or head and neck cancer while also looking at how to better match treatments to patients based on their tumor characteristics.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.