Digital Remote Monitoring of Immune Checkpoint Inhibitor Therapy Induced Toxicity: A Feasibility Study of the Vigilant App (Vigilant-2)

Last updated: April 22, 2025
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Melanoma

Skin Cancer

Treatment

Non-Interventional Study

Clinical Study ID

NCT06675643
23-011475
NCI-2024-09081
23-011475
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Any skin cancer/melanoma patient starting dual [ipilimumab/nivolumab (IPI/NIVO)]immune checkpoint inhibitor (ICI) therapy

Exclusion

Exclusion Criteria:

  • Does not meet inclusion criteria

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Non-Interventional Study
Phase:
Study Start date:
October 14, 2024
Estimated Completion Date:
March 15, 2026

Study Description

PRIMARY OBJECTIVES:

I. Optimize the patient (Aim 1) experience of the VIGILANT app workflow. II. Gather preliminary data on the number of patients who develop Grade 3 + 4 immune-related adverse event (irAE) or require ER visit within 100 days of registration and treatment with IPI/NIVO.

OUTLINE: This is an observational study.

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.

Connect with a study center

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

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