STRICT - Surveillance With TRoponin During Immune Checkpoint Therapy

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Immune Checkpoint Therapy

Treatments: Other: Standard of care; Diagnostic Test: Troponin surveillance

Study type: Interventional

Funder types: Other

Identifiers

NCT06337097

2023-1021

NCI-2024-02687 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 980 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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980 participants in 2 patient groups

Troponin Surveillance

Experimental group

Description:

Participants in Group 1, will have blood tests performed prior to each immune checkpoint inhibitor infusion for 12 weeks.

Treatment:

Diagnostic Test: Troponin surveillance

Standard of Care

Experimental group

Description:

Participants in Group 2, will have standard of care testing for any heart-related side effects of immune checkpoint inhibitors.

Treatment:

Other: Standard of care