Study on Digital Monitoring of Symptoms in Patients with Advanced Kidney Cancer Treated with Cabozantinib and Nivolumab

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What is this study about?

This clinical trial focuses on the treatment of advanced clear-cell renal carcinoma, a type of kidney cancer. The study involves two medications: Cabozantinib, known by its code name XL-184, which is taken as a tablet, and Nivolumab, also referred to as BMS936558, which is given through an infusion. These medications are used together to treat the cancer.

The purpose of the study is to evaluate how digital monitoring of symptoms reported by patients can help in managing their treatment. This involves patients using digital tools to report their symptoms, which can then be used to adjust their treatment plan. The study will observe how this approach affects the management of the treatment during the first three months.

Participants in the study will receive the combined treatment of Cabozantinib and Nivolumab. They will be asked to report their symptoms digitally on a regular basis. The study will monitor how these reports can lead to changes in treatment, such as scheduling earlier consultations or making adjustments to the medication. The study aims to improve the way treatments are managed for patients with advanced clear-cell renal carcinoma.

1 beginning of treatment

Upon joining the study, you will begin treatment for advanced clear-cell kidney cancer. This involves taking two medications: cabozantinib and nivolumab.

Nivolumab is administered as an infusion, which means it is given directly into your bloodstream through a vein. This will be done at a healthcare facility.

Cabozantinib is taken orally in the form of a tablet. You will be instructed on the exact dosage and frequency by your healthcare provider.

2 digital symptom monitoring

Throughout the first three months of treatment, you will participate in digital monitoring of your symptoms. This involves regularly reporting any symptoms or side effects you experience.

The information you provide will help adjust your treatment plan as needed. This may include scheduling additional consultations, phone follow-ups, or receiving advice on managing symptoms.

3 treatment management adjustments

Based on the symptoms you report, your treatment plan may be adjusted. This could involve changes in medication dosage, frequency, or even temporary discontinuation if necessary.

In some cases, hospitalization may be required to manage severe symptoms or side effects.

4 end of initial monitoring period

After the first three months, the initial phase of digital symptom monitoring concludes. Your healthcare provider will review your progress and discuss the next steps in your treatment plan.

Who Can Join the Study?

Patient must be older than 18 years.
Patient must have a diagnosis of Renal Cell Carcinoma (RCC) with a clear-cell component. RCC is a type of kidney cancer, and a clear-cell component refers to a specific appearance of the cancer cells under a microscope.
Patient must not have had any prior systemic treatment for RCC. Systemic treatment means any treatment that affects the entire body, such as chemotherapy.
The decision to treat the patient with cabozantinib and nivolumab in combination must be made by the doctor before joining the study. These are specific medications used to treat kidney cancer.
Patient must be affiliated with an appropriate social security system.
Patient must have signed informed consent before any trial-related activities. Informed consent is a process where the patient agrees to participate in the study after understanding all the details and risks involved.

Who Cannot Join the Study?

Patients who do not have kidney cancer cannot participate.
Patients who are not within the specified age range cannot participate. The study is for adults only.
Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Hospital Foch	Suresnes	France
Institut Sainte Catherine	Avignon	France
Groupe Hospitalier Bretagne Sud	Lorient	France
Centre Hospitalier De Boulogne Sur Mer	Boulogne sur Mer	France
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace	Mulhouse	France
Centre Francois Baclesse	Caen	France
Centre Hospitalier Aunay Bayeux	Bayeux	France
Clinique De Flandre	Coudekerque Branche	France
Coqniv Ltmm Bcqyjb	Lyon	France
Gqxfwy Hfciaeljkjp Pjsobz Df Svo Du L Oogl	Creil	France
Cat dwicejixjxhkkp	Epagny Metz Tessy	France
Cyxvld Hcnslguiqqj Rpepwtzp Uryqsxngfztzh Da Tslwy	Tours	France
Inzichng dr Cveushtjecte Hvetzxrxous Uiyohzhmdzfmw dh Slflq Eldhgus (tcwdkgr	Saint Priest En Jarez	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.04.2025

Trial locations

Investigated drugs:

Cabozantinib is a medication used to treat advanced kidney cancer. It works by blocking certain proteins that help cancer cells grow and spread. By interfering with these proteins, cabozantinib can slow down or stop the growth of cancer cells, helping to manage the disease.

Nivolumab is a type of immunotherapy used to treat advanced kidney cancer. It helps your immune system recognize and attack cancer cells more effectively. Nivolumab works by blocking a protein that prevents the immune system from attacking cancer cells, allowing your body to better fight the cancer.

Kidney Cancer – Kidney cancer is a type of cancer that begins in the kidneys, which are two bean-shaped organs located behind the abdominal organs. The most common type of kidney cancer in adults is renal cell carcinoma, which usually starts in the lining of tiny tubes in the kidney. As the disease progresses, cancer cells can grow and form a mass or tumor, potentially spreading to other parts of the body. The progression of kidney cancer can lead to symptoms such as blood in the urine, persistent pain in the back or side, and unexplained weight loss. The disease may advance to affect kidney function and can spread to nearby lymph nodes or distant organs. The rate of progression can vary significantly among individuals.

Trial ID:

2024-518991-30-00

Protocol code:

CANIQOL

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Digital Monitoring of Symptoms in Patients with Advanced Kidney Cancer Treated with Cabozantinib and Nivolumab

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?