Actively 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
Led by Hospices Civils de Lyon · Updated on 2024-10-16
100
Participants Needed
10
Research Sites
391 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 18 years
- Diagnosed with melanoma, lung cancer, or renal cancer
- Starting treatment with nivolumab plus ipilimumab combination immunotherapy or adjuvant nivolumab monotherapy (previous immunotherapy allowed)
- Comfortable using digital tools and computers
- Agree to participate in telemonitoring and signed consent form
You will not qualify if you...
- Pregnant, parturient, or lactating women
- Patients under legal protection or deprived of liberty
- Patients not affiliated with a social security scheme or similar regime (e.g., foreign persons outside the EU)
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Groupement hospitalier Est - Multidisciplinary oncological platform
Bron, France
Not Yet Recruiting
2
Hôpital Louis Pradel - Department of Pneumology
Bron, France
Not Yet Recruiting
3
University hospital of Grenoble Alpes - Department of dermatology
Grenoble, France
Not Yet Recruiting
4
University hospital of Grenoble Alpes - Department of Medical Oncology
Grenoble, France
Not Yet Recruiting
5
Hôpital de la Croix Rousse - Department of Pneumology
Lyon, France
Not Yet Recruiting
6
Hôpital Edouard Herriot - Department of urology
Lyon, France
Terminated
7
Centre Hospitalier Lyon Sud - Department of Medical Oncology
Pierre-Bénite, France
Actively Recruiting
8
Hôpital Lyon Sud - Department of Dermatology, HCL-Cancer Institute
Pierre-Bénite, France
Actively Recruiting
9
Hôpital Lyon Sud - Department of pneumology,Thoracic oncology
Pierre-Bénite, France
Actively Recruiting
10
University hospital of Saint-Etienne - Department of dermatology
Saint-Etienne, France
Not Yet Recruiting
Research Team
S
Stéphane DALLE
CONTACT
A
Aurélie RABIER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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