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Impact of Telemonitoring for the Management of Side Effects in Patients With Melanoma, Lung or Renal Cancer, Treated With Immunotherapy Combination of Nivolumab and Ipilimumab or Adjuvant Nivolumab Monotherapy — MONITOR  

Lung Cancer Clinical Trial

Official title:
Impact of Telemonitoring for the Management of Side Effects in Patients With Melanoma, Lung or Renal Cancer, Treated With Immunotherapy Combination of Nivolumab and Ipilimumab or Adjuvant Nivolumab Monotherapy

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04605146
Study type Interventional
Source Hospices Civils de Lyon
Contact Stéphane DALLE
Phone 0478861679
Email stephane.dalle@chu-lyon.fr
Status Recruiting
Phase N/A
Start date May 5, 2021
Completion date May 11, 2028
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