Using telemonitoring to manage side effects in cancer patients receiving immunotherapy
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
Run by Hospices Civils de Lyon · NCT04605146 · Data updated 2026-11-12
This study is testing if a telemonitoring system can help cancer patients receiving immunotherapy for melanoma, lung cancer, or renal cancer manage their side effects better by reporting their symptoms regularly.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Drugs / interventions | nivolumab, ipilimumab, immunotherapy |
| Locations | 10 sites (Bron and 9 other locations) |
| Status | Recruiting |
| Started | May 5, 2021 |
| Main results expected | November 5, 2028 |
| Study ends | November 5, 2028 |
| Registry record updated | October 16, 2024 |
| Trial ID | NCT04605146 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 years old diagnosed with melanoma, lung cancer, or renal cancer who are starting treatment with nivolumab and ipilimumab.
✕Probably not a fit
Patients who are pregnant, under legal protection, or not affiliated with a social security scheme may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of a telemonitoring system designed to manage side effects in patients with melanoma, lung cancer, or renal cancer who are being treated with the immunotherapy combination of nivolumab and ipilimumab or adjuvant nivolumab monotherapy. Patients will complete a simplified medical questionnaire weekly, which will provide clinicians with regular feedback on their symptoms. The goal is to reduce the time between the onset of adverse events and their reporting to healthcare providers, thereby improving patient management. This randomized prospective trial aims to assess the efficacy of this remote monitoring approach.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection and management of severe side effects, improving patient outcomes and quality of life.
How similar studies have gone: Other studies have shown promise in using telemonitoring for managing side effects in cancer treatments, indicating that this approach is both relevant and potentially effective.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
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Centre Hospitalier Lyon Sud - Department of Medical Oncology
Pierre-Bénite, France Recruiting -
Hôpital Lyon Sud - Department of Dermatology, HCL-Cancer Institute
Pierre-Bénite, France Recruiting -
Hôpital Lyon Sud - Department of pneumology,Thoracic oncology
Pierre-Bénite, France Recruiting -
Groupement hospitalier Est - Multidisciplinary oncological platform
Bron, France Not yet recruiting -
Hôpital Louis Pradel - Department of Pneumology
Bron, France Not yet recruiting -
University hospital of Grenoble Alpes - Department of dermatology
Grenoble, France Not yet recruiting
Show 4 more locations
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University hospital of Grenoble Alpes - Department of Medical Oncology
Grenoble, France Not yet recruiting -
Hôpital de la Croix Rousse - Department of Pneumology
Lyon, France Not yet recruiting -
Hôpital Edouard Herriot - Department of urology
Lyon, France Terminated -
University hospital of Saint-Etienne - Department of dermatology
Saint-Etienne, France Not yet recruiting
Study contacts
- Principal investigator: Stéphane DALLE — Department of Dermatology, HCL-Cancer Institute
- Study coordinator: Stéphane DALLE
- Email: stephane.dalle@chu-lyon.fr
- Phone: 0478861679
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Relatlimab, nivolumab, and ipilimumab for melanoma that has spread to the brain
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Triplet combination of Relatlimab, Nivolumab, and Ipilimumab in first-line metastatic melanoma
A first-line trial tests whether a three-drug combo can help people with metastatic melanoma, starting at a recommended dose.
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Oral Alintegimod with Ipilimumab followed by Nivolumab for advanced cancer
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Combining Sarilumab with Other Treatments for Advanced Melanoma
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.