Malignant Skin NeoplasmNCT06675643
Digital Remote Monitoring of Immune Checkpoint Inhibitor Therapy Induced Toxicity Using the Vigilant App
An observational study of Malignant Skin Neoplasm and Melanoma, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Skin Neoplasm, Melanoma
- What is being tested?
- Non-Interventional Study
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2024to 15 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with the diagnosis of skin cancer/melanoma undergoing dual ICI therapy with ipilimumab/nivolumab (IPI/Nivo) as part of regular clinical practice.
Who may be able to join
- Any skin cancer/melanoma patient starting dual [ipilimumab/nivolumab (IPI/NIVO)] immune checkpoint inhibitor (ICI) therapy
Who cannot join
- Does not meet inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Renee Bradshaw contact
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Renee Bradshaw, 507-284-2511
About this study
Official title: Digital Remote Monitoring of Immune Checkpoint Inhibitor Therapy Induced Toxicity: A Feasibility Study of the Vigilant App (Vigilant-2)
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Malignant Skin Neoplasm, Melanoma
- Being tested
- Non-Interventional Study
- Medical subject headings
- Skin Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-Interventional study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade 3-4 IR-adverse events
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.
Measured: Up to 100 days following treatment with IPI/NIVO
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start14 Oct 2024
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Skin NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Svetomir N. Markovic, MD, PhD, Principal investigator, Mayo ClinicLisa A. Kottschade, APRN, CNP, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675643
- Sponsor's protocol ID
- 23-011475
- Other IDs
- NCI-2024-09081, 23-011475
- Status last verified
- Aug 2026
- First submitted
- 4 Nov 2024
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Remote Monitoring of Immune Checkpoint Inhibitor Therapy Induced Toxicity: A Feasibility Study of the Vigilant App (Vigilant-2)
- ClinicalTrials.gov ID
- NCT06675643
- Acronym / sponsor ID
- 23-011475
- Conditions
- Malignant Skin Neoplasm, Melanoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with the diagnosis of skin cancer/melanoma undergoing dual ICI therapy with ipilimumab/nivolumab (IPI/Nivo) as part of regular clinical practice.
Key inclusion criteria (1 listed)
- Any skin cancer/melanoma patient starting dual [ipilimumab/nivolumab (IPI/NIVO)] immune checkpoint inhibitor (ICI) therapy
Key exclusion criteria (1 listed)
- Does not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyNon-Interventional study | Other | Observational |
Primary outcome
Incidence of grade 3-4 IR-adverse events
Time frame: Up 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Renee Bradshaw contact
Svetomir N. Markovic, MD, PhD principal investigator
Mayo Clinic
Lisa A. Kottschade, APRN, CNP principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Skin Neoplasm and Melanoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of grade 3-4 IR-adverse events (time frame: Up to 100 days following treatment with IPI/NIVO). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.