Using a mobile app to monitor side effects of melanoma treatment
Official title: Digital Remote Monitoring of Immune Checkpoint Inhibitor Therapy Induced Toxicity: A Feasibility Study of the Vigilant App (Vigilant-2)
Run by Mayo Clinic · NCT06675643 · Data updated 2026-11-12
This study is testing a mobile app that helps people with melanoma track their symptoms while receiving treatment to see how well it works in managing side effects.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | ipilimumab, nivolumab |
| Locations | 1 site (Rochester, Minnesota) |
| Status | Recruiting |
| Started | October 14, 2024 |
| Main results expected | March 15, 2027 |
| Study ends | March 15, 2027 |
| Registry record updated | August 6, 2026 |
| Trial ID | NCT06675643 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with malignant skin neoplasms, specifically those starting dual immune checkpoint inhibitor therapy with ipilimumab and nivolumab.
✕Probably not a fit
Patients who are not starting treatment with ipilimumab and nivolumab or those who do not have melanoma 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 observational study aims to evaluate the patient experience with the Vigilant mobile application, which is designed to monitor symptoms in patients undergoing treatment with ipilimumab and nivolumab for melanoma. Patients will report their symptoms and vital signs through the app, allowing healthcare providers to assess the severity of adverse events and recommend appropriate actions. The study will also collect preliminary data on the incidence of severe immune-related adverse events and emergency room visits within 100 days of treatment initiation.
Why it matters
Potential benefit: If successful, this approach could enhance patient safety and improve management of treatment-related side effects for melanoma patients.
How similar studies have gone: Other studies have shown promise in using mobile applications for remote monitoring of patient symptoms, indicating potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Any skin cancer/melanoma patient starting dual \[ipilimumab/nivolumab (IPI/NIVO)\] immune checkpoint inhibitor (ICI) therapy Exclusion Criteria: * Does not meet inclusion criteria
Where it's running
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Mayo Clinic in Rochester
Rochester, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Svetomir N. Markovic, MD, PhD — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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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.