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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

RECRUITINGN/ASponsored by Hospices Civils de Lyon
Actively Recruiting
PhaseN/A
SponsorHospices Civils de Lyon
Started2021-05-05
Est. completion2028-11-05
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Age: 18 Years+Healthy volunteers accepted
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)

Conditions4

CancerLung CancerMelanomaRenal Cancer

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