Phone App Tracks Side Effects in People with Melanoma on Immune Therapy
Studies a phone app that monitors side effects in adults with melanoma.
Key facts
- Who runs it
- Mayo Clinic
- Where
- Rochester, United StatesSee the site
- Trial code
- Registry title
- Digital Remote Monitoring of Immune Checkpoint Inhibitor Therapy Induced Toxicity Using the Vigilant App
- Status
- Recruiting
- People taking part
- 100 people, planned
- Started
- 14 Oct 2024
- Expected to end
- 15 Mar 2027
- Type of study
- Observational
- Treatments tested
- Non-Interventional Study
- Record updated
- 6 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with skin cancer or melanoma who are starting treatment with two immune therapy drugs, ipilimumab and nivolumab. It tests a mobile app for tracking symptoms.
- Age
- 18 years or older
- Sex
- Men and women can join.
- Disease stage
- Any skin cancer or melanoma.
- Earlier treatment
- People must be starting dual immune checkpoint inhibitor therapy (ipilimumab/nivolumab).
Main reasons for not taking part
- People who do not meet the inclusion criteria cannot join.
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- Any skin cancer/melanoma patient starting dual [ipilimumab/nivolumab (IPI/NIVO)] immune checkpoint inhibitor (ICI) therapy
Who cannot take part
- Does not meet inclusion criteria
Where in United States
- Mayo Clinic in RochesterRochester, United StatesContact: Clinical Trials Referral OfficeTaking people
About the trial
What the trial wants to find out
This study is being done to better understand patient experiences with using a mobile application, known as Vigilant, to monitor symptoms as outpatients and to gather preliminary data on the potential clinical benefit to remote monitoring of adverse events.
The group in the trial
- Observational
Patients undergo standard of care treatment with ipilimumab/nivolumab and answer questions and enter symptoms in the mobile Vigilant application. Patients wearing a compatible watch have their vital signs recorded at the same time symptoms are being entered. Based on the severity of symptoms, patients may be recommended to reach out to their healthcare team or to go to the emergency room. Additionally, patients complete a survey and may have their medical charts reviewed on study.
Treatment: Non-Interventional Study
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Digital Remote Monitoring of Immune Checkpoint Inhibitor Therapy Induced Toxicity: A Feasibility Study of the Vigilant App (Vigilant-2)
- Plain-language title
- Phone App Tracks Side Effects in People with Melanoma on Immune TherapyGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 6 August 2026