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Study identifier: NCT04605146 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Melanoma · Lung Cancer · Renal Cancer  ·  Sponsor: Hospices Civils de Lyon

PhaseNA
Planned participants100
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

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.

This description comes directly from the study's public registry record.

Talk to the study team

Stéphane DALLE  ·  0478861679  ·  stephane.dalle@chu-lyon.fr

Aurélie RABIER  ·  0478861679  ·  aurelie.rabier@chu-lyon.fr

Always discuss trial participation with your own doctor first.

Locations (10)

Groupement hospitalier Est - Multidisciplinary oncological platformBron, FranceNot Yet Recruiting
Hôpital Louis Pradel - Department of PneumologyBron, FranceNot Yet Recruiting
University hospital of Grenoble Alpes - Department of dermatologyGrenoble, FranceNot Yet Recruiting
University hospital of Grenoble Alpes - Department of Medical OncologyGrenoble, FranceNot Yet Recruiting
Hôpital de la Croix Rousse - Department of PneumologyLyon, FranceNot Yet Recruiting
Hôpital Edouard Herriot - Department of urologyLyon, FranceTerminated
Centre Hospitalier Lyon Sud - Department of Medical OncologyPierre-Bénite, FranceRecruiting
Hôpital Lyon Sud - Department of Dermatology, HCL-Cancer InstitutePierre-Bénite, FranceRecruiting
Hôpital Lyon Sud - Department of pneumology,Thoracic oncologyPierre-Bénite, FranceRecruiting
University hospital of Saint-Etienne - Department of dermatologySaint-Etienne, FranceNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT04605146