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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

RecruitingNAAges 18 Years - anyAllHospices Civils de Lyon
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In plain words

What the trial is, and whether it could suit you

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 e

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📋 Eligibility rules (as published)
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)
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What it tests

  • Tele-monitoring
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Where

10 sites
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
University hospital of Grenoble Alpes - Department of Medical Oncology
Grenoble, France
Hôpital de la Croix Rousse - Department of Pneumology
Lyon, France
Hôpital Edouard Herriot - Department of urology
Lyon, France
Centre Hospitalier Lyon Sud - Department of Medical Oncology
Pierre-Bénite, France
Hôpital Lyon Sud - Department of Dermatology, HCL-Cancer Institute
Pierre-Bénite, France

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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