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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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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