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Observational Study of the Vigilant App for Melanoma Patients on Ipilimumab/Nivolumab

This study is looking at how well a mobile app called Vigilant helps patients with skin cancer (melanoma) monitor their symptoms while receiving treatment with ipilimumab/nivolumab. This treatment is a type of immune checkpoint inhibitor (ICI) that works by boosting your body's immune system to fight cancer. The study wants to understand your experience using the app and to see if remote monitoring can help detect serious side effects (called immune-related adverse events or irAEs) early. You can join if you are an adult with skin cancer/melanoma starting ipilimumab/nivolumab. The main goal is to see how many patients develop severe side effects within 100 days of starting treatment. The study's current status is unclear, and it plans to enroll 100 participants.

Study design
This is an observational study involving 100 participants. It is not a drug trial but rather looks at how patients use a mobile app.
What's involved
You will use the Vigilant app to answer questions and enter symptoms. If you wear a compatible watch, your vital signs may also be recorded. You will also complete a survey, and your medical charts may be reviewed.
Compensation
Not stated in the trial record.
Follow-up
The study measures severe side effects up to 100 days following treatment with ipilimumab/nivolumab.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06675643

Digital Remote Monitoring of Immune Checkpoint Inhibitor Therapy Induced Toxicity Using the Vigilant App

Recruiting
Not specifiedAges 18+Observational
Mayo Clinic
~100 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:Non-Interventional Study

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of grade 3-4 IR-adverse events
Measured over Up to 100 days following treatment with IPI/NIVO

Conditions

Malignant Skin Neoplasm
Melanoma

Explore related trials

Malignant Skin NeoplasmMelanoma

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Svetomir N. Markovic, MD, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
  • Lisa A. Kottschade, APRN, CNP · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Eligibility criteria

Inclusion

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

What this trial measures

  • Incidence of grade 3-4 IR-adverse eventsUp to 100 days following treatment with IPI/NIVO

    Will be assessed by the number of patients who experience at least one grade 3-4 Immune-Related Adverse Events (IR-AE) within 100 days of treatment with ipilimumab/nivolumab (IPI/NIVO). Events will be self-reported using the VIGILANT app, which is being developed to help manage adverse events after treatment.