A Web-mediated Follow-up With the Web-application KidneyPRO Versus Standard Follow-up for Patients With Advanced Renal Cell Carcinoma Treated With Axitinib/Pembrolizumab in First Line — AxiPRO  

Renal Cell Carcinoma Metastatic Clinical Trial

Official title: A Web-mediated Follow-up With the Web-application KidneyPRO Versus Standard Follow-up for Patients With Advanced Renal Cell Carcinoma Treated With Axitinib/Pembrolizumab in First Line

Status Recruiting

Clinical Trial Summary

With the advent of immunotherapy, standard first-line treatment for patients with renal cell carcinoma is now an association with an immune checkpoint inhibitor. In this context, the association axitinib plus pembrolizumab has already been evaluated in several studies with positive results for Progression Free survival, Overall survival and Complete response. The combo received a positive opinion from the Committee for Medicinal Products for Human Use, and the European Commission approves the extension of Marketing Authorization in first line for metastatic renal cell carcinoma patients. In a context of treatment with a new association, it is important to manage the toxicities closely in order to allow the patients to have an optimal treatment. The underlying hypothesis is that the use of new information and communication technologies could improve clinical patient management. In this study, we wish assess the impact of monitoring via the web application KidneyPRO on the quality of life of patients with the new combination of treatment axitinib/pembrolizumab for a renal cell carcinoma in first line.

Clinical Trial Description

Metastatic or locally advanced clear cell renal carcinomas (RCC) are treated with targeted therapies (inhibitors of tyrosine kinases) and immune check-points inhibitors. In first line many combos are tested. Association of TKI-PD L1-inhibitor is one option. Axitinib-Pembrolizumab showed very high response rate and progression free survival compared to Sunitinib but immunotherapies have a specific adverse event profile. Actually, there is no standardized follow-up for this type of treatment. It is important to develop new strategies that reduce the resources used while improving the performance of this surveillance for the benefit of patients, to improve the comfort of patients, to improve the compliance and to optimise the dose of treatment received, in a course of care reworked by maintaining a continuous contact not demanding. In collaboration with the Scientific Research National Center, the theory of chaos and its derivatives was applied to cancer and a web-application was developed on these concepts to remotely analyze the dynamics of the symptoms felt by the patient and early detect a recurrence or a complication of his cancer. Clinical symptoms are self-assessed by patients once a week, transcribed on their smartphone or computer through the Internet application. Relevant clinical events are detected using data processing algorithms, combining the dynamics of the various reported symptoms. In this case, an alert message is sent to the health care team. The referring oncologist is thus warned early. He can then make a telephone call to the patient about the reality of the medical alert and summon him for a check-up or any other complementary examination. Applied to lung cancer, this application is a tried-and-tested solution with a phase III clinical trial. The main criteria was overall survival. The monitoring of these patients with the web-application and with a number of scanners reduced by 50% compared to the reference arm, made it possible to diagnose relapses earlier, to treat them under better conditions and, above all, to improve statistically significant overall survival (a gain in overall survival of 26% at 1 year (in patients intending to treat): 49% in the standard arm versus 75% in the experimental arm: p = 0.0025. This profit persists with 2 years of decline (a median gain in overall survival of 7.6 months, p=0.0312). This concept was confirmed in the NCT0578006 study published by Basch et al. Basch used a similar application during chemotherapy treatment in 766 cancer patients. The web-application has improved overall survival by 5 months (Hazard ratio: 0.83). This web-application provided a statistical improvement in the quality of life for lung cancer, access to new therapeutic lines (74% versus 33%, p <0.001) and optimally with treatments delivered at therapeutic doses (in 76% versus 34%) and faster access to supportive care for a clear improvement in the general condition of patients (77 versus 33%, p <0.001). The key for these patients who experienced many treatment toxicities was to use a better method of active follow-up. A real-time survey of quality of life of Renal Cell Cancer patients receiving Axitinib/Pembrolizumab is an objective that has never been evaluated. This study will allow to generate data in patients who were not included in the phase III study (KEYNOTE 426): Performance Status =2, with central nervous system metastasis and with renal insufficiency. Personalized monitoring of these patients with the web-application KidneyPRO is even more relevant because the aim would be to quickly provide care adapted to adverse events, supportive care in case of loss of activity… The web-application KidneyPRO investigated has been developed for this purpose. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma Metastatic

• NCT number: NCT04764487
• Study type: Interventional
• Source: Weprom
• Contact: Magali BALAVOINE
• Phone: 2 41 68 29 70
• Email: m.balavoine@weprom.fr
• Status: Recruiting
• Phase: Phase 3
• Start date: June 7, 2021
• Completion date: June 15, 2025