Clinical trial NCT04605146: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Melanoma
Lung Cancer
Renal Cancer
Keywords: Tele-monitoring
nivolumab
ipilimumab
immunotherapy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-10-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 criteria: Inclusion Criteria:

* 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 Criteria:

* 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)

Primary outcomes:
measure: Delay between the start of a side effect and reporting to the medical team (average number of days per patient).
timeFrame: 12 months
Secondary outcomes:
measure: Levels of morbidity based on CTC-AE v5 (all toxicities)
timeFrame: 12 months
measure: Number of treatment interruptions and number of days of treatment delays interruptions, number of treatment discontinuation, number of dose reductions and and percentage of dose reduction
timeFrame: 12 months
measure: Number of admissions in the emergency room
timeFrame: 12 months
measure: Number of unplanned hospitalizations
timeFrame: 12 months
measure: Number of contact with general practitioner
timeFrame: 12 months
measure: benefit for clinicians: interview of clinicians on their opinion on the self-monitoring, evaluation to the impact on the consultations during the first year of treatment, assessed with satisfaction questionnaires
timeFrame: Month 12
measure: Number of AE identified by clinicians
timeFrame: 12 months
measure: Overall quality of Life assessed with standardized QoL questionnaires (FACT-G)
timeFrame: 12 months
measure: Adherence: The number of full symptoms report completions and adherence to the completion schedule
timeFrame: 12 months
Other outcomes:
measure: Overall Survival and Progression Free Survival assessed at 1 year after inclusion
timeFrame: At 1 year after inclusion
measure: Overall Survival and Progression Free Survival assessed at 2 years after inclusion
timeFrame: At 2 years after inclusion
measure: Overall Survival and Progression Free Survival assessed at 5 years after inclusion
timeFrame: At 5 years after inclusion
Locations:
city: Bron
country: France
facility: Groupement hospitalier Est - Multidisciplinary oncological platform
city: Bron
country: France
facility: Hôpital Louis Pradel - Department of Pneumology
city: Grenoble
country: France
facility: University hospital of Grenoble Alpes - Department of dermatology
city: Grenoble
country: France
facility: University hospital of Grenoble Alpes - Department of Medical Oncology
city: Lyon
country: France
facility: Hôpital de la Croix Rousse - Department of Pneumology
city: Lyon
country: France
facility: Hôpital Edouard Herriot - Department of urology
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud - Department of Medical Oncology
city: Pierre-Bénite
country: France
facility: Hôpital Lyon Sud - Department of Dermatology, HCL-Cancer Institute
city: Pierre-Bénite
country: France
facility: Hôpital Lyon Sud - Department of pneumology,Thoracic oncology
city: Saint-Étienne
country: France
facility: University hospital of Saint-Etienne - Department of dermatology
Study officials:
affiliation: Department of Dermatology, HCL-Cancer Institute
name: Stéphane DALLE
role: PRINCIPAL_INVESTIGATOR
References: