Effects of Immune Checkpoint Inhibitors on Coronary Microvasculature

April 9, 2024 updated by: Abramson Cancer Center at Penn Medicine
This is an observational study that includes patients with melanoma who will be treated with adjuvant immune checkpoint inhibitor (ICI) therapy. The investigators will use echocardiograms, blood draws, and PET stress tests to understand how ICI therapy affects the heart and circulatory system.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center at University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with melanoma who are planned for adjuvant treatment with ICI therapy will be enrolled.

Description

Inclusion Criteria:

  • ≥18 years of age
  • Diagnosis of Melanoma and planned to undergo adjuvant therapy with immune checkpoint inhibitors.
  • Able to provide written informed consent

Exclusion Criteria:

  • Pregnant or breast-feeding:
  • Prior treatment with ICI therapy.
  • Vulnerable patients, including pregnant women and prisoners
  • Absolute Contraindication to rest/vasodilator stress PET/CT

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of new abnormal myocardial blood flow reserve (MBFR)
Time Frame: 12 months
Development of MBFR<2
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause mortality
Time Frame: 12 months
All cause mortality
12 months
Incidence of major cardiovascular events
Time Frame: 12 months
Composite measure including new/worsened heart failure, MI, stroke, myocarditis
12 months
Cardiovascular specific mortality
Time Frame: 12 months
Cardiovascular specific mortality
12 months
Coronary calcium score
Time Frame: 12 month
Change in PET derived Coronary Calcium (CAC) Score from baseline. CAC ranges from 0-400 agatson units; higher CAC indicates larger amounts of calcium are present in the coronary arteries.
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center at Penn Medicine

Investigators

  • Principal Investigator: Marielle Scherrer-Crosbie, MD, PhD, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

March 20, 2024

First Submitted That Met QC Criteria

March 20, 2024

First Posted (Actual)

March 27, 2024

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC07623

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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