STRICT - Surveillance With TRoponin During Immune Checkpoint Therapy

Phase 3

Recruiting

• Conditions: Immune Checkpoint Therapy
• Interventions: Other: Standard of care; Diagnostic Test: Troponin surveillance

• Registration Number: NCT06337097
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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.

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

Study Timeline

• Study Start: 2024-02-02
• Study First Submitted: 2024-03-22
• Study First Submitted QC: 2024-03-28
• Study First Posted: 2024-03-29
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2026-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 880

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of care	Participants in Group 2, will have standard of care testing for any heart-related side effects of immune checkpoint inhibitors.
Troponin Surveillance	Troponin surveillance	Participants in Group 1, will have blood tests performed prior to each immune checkpoint inhibitor infusion for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Safety and adverse events (AEs)	Through study completion; an average of 1 year.	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States