Loading clinical trials...
Loading clinical trials...
The ipilimumab and nivolumab combination is now part of the standard of care for the treatment of melanoma, renal and lung cancer patients. Grade 3/4 adverse events (AEs) occur in 30 to 60% of patients included in clinical trials. Grade 3/4 AEs are more frequently observed (50-60% of patients) in melanoma because ipilimumab is administrated at 3mg/kg in this population. Among these AEs, early detection of immune related AEs is critical to an adequate medical management. In this context, dedicated tools for remote monitoring of these patients are crucial. The investigators developed within the Immucare consortium a simplified medical questionnaire which is addressed weekly to the patients. This questionnaire along with an algorithm gives to the clinician regular feedback on their patients' general symptoms. The investigators herein want to evaluate in a randomized prospective trial the efficacy of this remote monitoring to reduce the time between the start of AE and the reporting to the medical team, which could lead to detect and treat earlier AEs induced by nivolumab and ipilimumab in the melanoma, lung and renal cancer patients' population.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Groupement hospitalier Est - Multidisciplinary oncological platform
Bron, France
Hôpital Louis Pradel - Department of Pneumology
Bron, France
University hospital of Grenoble Alpes - Department of dermatology
Grenoble, France
University hospital of Grenoble Alpes - Department of Medical Oncology
Grenoble, France
Hôpital de la Croix Rousse - Department of Pneumology
Lyon, France
Hôpital Edouard Herriot - Department of urology
Lyon, France
Centre Hospitalier Lyon Sud - Department of Medical Oncology
Pierre-Bénite, France
Hôpital Lyon Sud - Department of Dermatology, HCL-Cancer Institute
Pierre-Bénite, France
Hôpital Lyon Sud - Department of pneumology,Thoracic oncology
Pierre-Bénite, France
University hospital of Saint-Etienne - Department of dermatology
Saint-Etienne, France
Start Date
May 5, 2021
Primary Completion Date
November 5, 2028
Completion Date
November 5, 2028
Last Updated
October 16, 2024
100
ESTIMATED participants
Tele-monitoring
BEHAVIORAL
Lead Sponsor
Hospices Civils de Lyon
NCT06066138
NCT06305754
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions