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
About this study
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.
- Condition
- Melanoma, Lung Cancer, Renal Cancer
- Tested
- Tele-monitoring
- Sponsor
- Hospices Civils de Lyon
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 7
- Minimum age: 18 years
- Study condition: Melanoma, Lung Cancer, Renal Cancer
- Age \> 18 years
- Patients diagnosed with melanoma, or lung cancer or renal cancer
- Patients starting a treatment with a combination of immunotherapy of nivolumab + ipilimumab (NB: patients who have already received immunotherapy in the past may be included)
- Patients comfortable with the use of digital tools and computing
- Patients who agree to participate to the telemonitoring and signed consent form
Exclusion 3
- Pregnant, parturient and lactating women
- Patients under legal protection measure or deprived of their liberty
- Patients not affiliated to a social security scheme (schemes such as the AME) or beneficiaries of a similar regime (foreign person, outside the EU)
Where
10 sites, 9 recruiting
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
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
and 4 more sites on ClinicalTrials.gov
Contact
-
Stéphane DALLE
0478861679 stephane.dalle@chu-lyon.fr
-
Aurélie RABIER
0478861679 aurelie.rabier@chu-lyon.fr
Potential match only. Final eligibility is determined by the study team.