NCT07028125 Digital Monitoring of Self-reported Symptoms by Patients Treated With Cabozantinib Plus Nivolumab for Advanced Clear-cell Renal Carcinoma
| NCT ID | NCT07028125 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Centre Francois Baclesse |
| Condition | Renal Cell Carcinoma (Kidney Cancer) |
| Study Type | INTERVENTIONAL |
| Enrollment | 83 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2028-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 83 participants in total. It began in 2025-10-01 with a primary completion date of 2028-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of the study is to evaluate the impact of digital monitoring of self-reported symptoms (PROs) on the adjustment of treatment management in patients treated with cabozantinib plus nivolumab for advanced clear cell renal cell carcinoma (RCC) in real life during the first 3 months of combined treatment
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07028125 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Renal Cell Carcinoma (Kidney Cancer). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07028125 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07028125 currently recruiting?
Yes, NCT07028125 is actively recruiting participants. Contact the research team at f.joly@baclesse.unicancer.fr for enrollment information.
Where is the NCT07028125 trial being conducted?
This trial is being conducted at Annecy, France, Avignon, France, Bayeux, France, Boulogne-sur-Mer, France and 11 additional locations.
Who is sponsoring the NCT07028125 clinical trial?
NCT07028125 is sponsored by Centre Francois Baclesse. The trial plans to enroll 83 participants.
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