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Digital Remote Monitoring of ICI Therapy

Overview

About this study

The current feasibility study has two aims: (1) optimize the patient (Aim 1a) and nurse (Aim 1b) experience of the VIGILANT app workflow; and (2) gather prliminary data on the number of patients who develop Grade 3 + 4 irAE or require ER visit within 100 days of registration and treatment with IPI/NIVO.  This effort will allow us to refine VIGILANT as we advance its development into a clinically useful device for remote patient monitoring and gather preliminary evidence on the potential clinical benefit of its use.

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Adults with the diagnosis of skin cancer/melanoma undergoing dual ICI therapy with ipilimumab/nivolumab (IPI/Nivo) as part of regular clinical practice.

Exclusion Criteria: 

  • None.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/3/23. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Svetomir Markovic, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

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CLS-20575493

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