STRICT - Surveillance With TRoponin During Immune Checkpoint Therapy

Purpose

To learn if monitoring blood levels of heart injury (troponin levels) in cancer participants treated with immune checkpoint inhibitors will lead to decreased heart-related side effects.

Condition

  • Immune Checkpoint Therapy

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Male or female patient ≥18 years old - Plan for treatment with an immune checkpoint inhibitor as standard of care even if patient is also on an additional investigational cancer therapeutic - Willingness to provide informed consent

Exclusion Criteria

  • Troponin T not available at screening or prior to randomization - Inability to comply with planned study procedures - Major adverse cardiovascular event included in the primary outcome within the 30 days prior to enrollment - Any medical condition that could interfere with, or for which the treatment might interfere with the conduct of the study or interpretation of the study results, or that would, in the opinion of the investigator, increase the risk of the participant by participating in the study - Any factors that, in the Investigator's opinion, are likely to interfere with study procedures, such as history of noncompliance with scheduled appointments.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Screening
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Troponin Surveillance 		Participants in Group 1, will have blood tests performed prior to each immune checkpoint inhibitor infusion for 12 weeks.
  • Diagnostic Test: Troponin surveillance
    Troponin will be monitored prior to each immune checkpoint inhibitor infusion for the first 12 weeks of therapy.
Experimental
Standard of Care 		Participants in Group 2, will have standard of care testing for any heart-related side effects of immune checkpoint inhibitors.
  • Other: Standard of care
    Standard of care if symptoms arise then evaluation with cardiac biomarkers and/or further cardiac testing.

Recruiting Locations

MD Anderson Cancer Center
Houston, Texas 77030
Contact:
Nicolas Palaskas, MD
713-606-3957
nlpalaskas@mdanderson.org

More Details

Status
Recruiting
Sponsor
M.D. Anderson Cancer Center

Study Contact

Nicolas Palaskas, MD
(713) 606-3957
nlpalaskas@mdanderson.org

Detailed Description

Primary Objectives: - Myocarditis CTCAE version 5.0 grade ≥ 3 - Ventricular tachycardia (≥ 30 seconds) - Advanced atrioventricular block - Incident heart failure event - Cardiovascular mortality - Non-fatal sudden cardiac arrest - Acute coronary syndrome - Pericarditis - Pericardial tamponade Secondary Objectives: - Time from symptom onset to diagnosis of major adverse cardiovascular events - Time from symptom onset to diagnosis of myocarditis - Initial hospitalization duration for the adverse cardiovascular event from primary endpoint - Peak biomarker levels including troponin T, troponin I, creatine kinase, and creatine kinase myocardial band - Percentage of patients with negative workup for myocarditis - Percentage of patients requiring major cardiac testing including echocardiograms, cardiac magnetic resonance imaging, and/or invasive heart catheterization - Duration of interruption and/or discontinuation of immune checkpoint inhibitor therapy - Cancer progression free survival - Time to next cancer therapy