Digital Monitoring of Self-reported Symptoms by Patients Treated With Cabozantinib Plus Nivolumab for Advanced Clear-cell Renal Carcinoma

Launched by CENTRE FRANCOIS BACLESSE · Jun 17, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how using digital tools to track symptoms reported by patients can help doctors better manage treatment for people with advanced kidney cancer, specifically a type called clear-cell renal cell carcinoma. The study focuses on patients who are starting a combination treatment with two medicines, cabozantinib and nivolumab, and follows them during the first three months of treatment to see if monitoring symptoms this way makes a difference in their care.

People who might join this study are adults diagnosed with advanced kidney cancer that hasn’t been treated with other systemic therapies before. Their doctor must have already decided to treat them with cabozantinib and nivolumab. Participants need to be comfortable using digital devices to report how they’re feeling and agree to use birth control if they could become pregnant during the study. The trial is not yet recruiting, and those interested should expect to regularly share information about their symptoms through digital tools, helping their healthcare team adjust treatment as needed. This approach aims to improve communication between patients and doctors and potentially lead to better management of side effects and overall care.

Gender

ALL

Eligibility 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