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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Groupement hospitalier Est - Multidisciplinary oncological platform
NOT_YET_RECRUITING
Bron
Hôpital Louis Pradel - Department of Pneumology
NOT_YET_RECRUITING
Bron
University hospital of Grenoble Alpes - Department of dermatology
NOT_YET_RECRUITING
Grenoble
University hospital of Grenoble Alpes - Department of Medical Oncology
NOT_YET_RECRUITING
Grenoble
Hôpital de la Croix Rousse - Department of Pneumology
NOT_YET_RECRUITING
Lyon
Hôpital Edouard Herriot - Department of urology
TERMINATED
Lyon
Centre Hospitalier Lyon Sud - Department of Medical Oncology
RECRUITING
Pierre-bénite
Hôpital Lyon Sud - Department of Dermatology, HCL-Cancer Institute
RECRUITING
Pierre-bénite
Hôpital Lyon Sud - Department of pneumology,Thoracic oncology
RECRUITING
Pierre-bénite
University hospital of Saint-Etienne - Department of dermatology
NOT_YET_RECRUITING
Saint-etienne
Contact Information
Primary
Stéphane DALLE
stephane.dalle@chu-lyon.fr
0478861679
Backup
Aurélie RABIER
aurelie.rabier@chu-lyon.fr
0478861679
Time Frame
Start Date: 2021-05-05
Estimated Completion Date: 2028-11-05
Participants
Target number of participants: 100
Treatments
Experimental: Tele-monitoring group
In the experimental group, in addition to routine practice, each patient will benefit of a tele-monitoring of one year, and a long term follow-up up to 5 years to evaluate the Overall Survival and the Progression-Free Survival. Quality of life questionnaire will also be filled in at inclusion, M3 and M12.~50 patients are expected in this arm.
No_intervention: Control group
In the control group, patients will have a routine follow-up as per institutional practice, and a long term follow-up up to 5 years to evaluate the Overall Survival and the Progression-Free Survival. Quality of life questionnaire will also be filled in at inclusion, M3 and M12.~50 patients are expected in this arm.
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov

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