Clinical trial · Observational
Immune Checkpoint Inhibitor Therapy for Cancer and Risk of Myocarditis or Cardiomyopathy
Association of Immune Checkpoint Inhibitor Therapy for Cancer With Early Myocardial Tissue and Biomarker Changes During Treatment - Implication for Risk of Myocarditis and Cardiomyopathy
NCT06309862CI-TRIAL-00077791unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients undergoing dual treatment with Immune checkpoint inhibitors (ICI) for various cancers, e.g. melanoma, are at increased risk of developing myocarditis and cardiomyopathy. Currently, only limited data on serial myocardial tissue changes during treatment and whether they predict outcomes are available. Cardiac MRI (CMR) is the reference standard for non-invasive myocardial volumes/function analysis and uniquely characterizes myocardial tissue. Therefore, it may help detect myocardial tissue changes during treatment and help early treatment and prevent adverse cardiac outcomes.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cardiomyopathy Due to Drug | — | UNRESOLVED | — |
| Cardio-Oncology | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Patients with skin cancer eligible for dual ICI treatment.
Primary outcomes (3)
- measure
- Define changes in CMR tissue and blood biomarkers during ICI treatment.
- timeFrame
- Baseline, 6 weeks and 6 months
- description
- The following parameters are investigated to assess for underlying myocardial remodelling and/or inflammation during treatment with ICI. Left ventricular volumes in ml Left ventricular ejection fraction in percentage T1 Mapping: T1 relaxation time in milliseconds T2 Mapping: T2 relaxation time in milliseconds ECV = (1-hematocrit) × (Δ(1/T1myocardium)/Δ(1/T1blood)) in percentage Strain (GCS, GLS, GRS) reported as a percentage, formula =(Max Length-Initial Length)/Initial Length LGE is qualitatively described as categorical variables e.g. epicardial, mid-myocardial, subendocardial or transmural. LGE is quantified as mass in gram and as percentage of the LV mass. High sensitivity troponin 1 nanogram/ mL B-type natriuretic peptide (BNP) nanogram/L High sensitivity CRP in mg/L
- measure
- Investigate associations between CMR imaging biomarkers and CMR-defined left ventricular ejection fraction.
- timeFrame
- Baseline, 6 weeks and 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All patients 18 years of age, or older, with skin cancer and eligible for ICI treatment with a combination of a) nivolumab, b) pembrolizumab, or c) ipilimumab. * Able to provide informed consent * Able to travel to SHSC for cardiac imaging. Exclusion Criteria: * Life expectancy equal to, or less than, 12 months * Participating in another clinical trial * Treated with ICI in the past * History of cardiac disease (e.g. heart failure, myocardial infarction, atrial fibrillation, unstable angina) * Pregnant patients * Impaired renal function (GFR equal to, or less than, 30mL/min) * Contraindications for MRI (e.g. pacemaker).
References
Publications (20)
- BACKGROUNDThavendiranathan P, Abdel-Qadir H, Fischer HD, Camacho X, Amir E, Austin PC, Lee DS. Breast Cancer Therapy-Related Cardiac Dysfunction in Adult Women Treated in Routine Clinical Practice: A Population-Based Cohort Study. J Clin Oncol. 2016 Jul 1;34(19):2239-46. doi: 10.1200/JCO.2015.65.1505. Epub 2016 Apr 18. PMID 27091709
- BACKGROUNDPostow MA, Callahan MK, Wolchok JD. Immune Checkpoint Blockade in Cancer Therapy. J Clin Oncol. 2015 Jun 10;33(17):1974-82. doi: 10.1200/JCO.2014.59.4358. Epub 2015 Jan 20. PMID 25605845
- BACKGROUNDPostow MA, Chesney J, Pavlick AC, Robert C, Grossmann K, McDermott D, Linette GP, Meyer N, Giguere JK, Agarwala SS, Shaheen M, Ernstoff MS, Minor D, Salama AK, Taylor M, Ott PA, Rollin LM, Horak C, Gagnier P, Wolchok JD, Hodi FS. Nivolumab and ipilimumab versus ipilimumab in untreated melanoma. N Engl J Med. 2015 May 21;372(21):2006-17. doi: 10.1056/NEJMoa1414428. Epub 2015 Apr 20. PMID 25891304
- BACKGROUNDWang DY, Salem JE, Cohen JV, Chandra S, Menzer C, Ye F, Zhao S, Das S, Beckermann KE, Ha L, Rathmell WK, Ancell KK, Balko JM, Bowman C, Davis EJ, Chism DD, Horn L, Long GV, Carlino MS, Lebrun-Vignes B, Eroglu Z, Hassel JC, Menzies AM, Sosman JA, Sullivan RJ, Moslehi JJ, Johnson DB. Fatal Toxic Effects Associated With Immune Checkpoint Inhibitors: A Systematic Review and Meta-analysis. JAMA Oncol. 2018 Dec 1;4(12):1721-1728. doi: 10.1001/jamaoncol.2018.3923. PMID 30242316
- BACKGROUNDLyon AR, Yousaf N, Battisti NML, Moslehi J, Larkin J. Immune checkpoint inhibitors and cardiovascular toxicity. Lancet Oncol. 2018 Sep;19(9):e447-e458. doi: 10.1016/S1470-2045(18)30457-1. PMID 30191849
- BACKGROUNDEscudier M, Cautela J, Malissen N, Ancedy Y, Orabona M, Pinto J, Monestier S, Grob JJ, Scemama U, Jacquier A, Lalevee N, Barraud J, Peyrol M, Laine M, Bonello L, Paganelli F, Cohen A, Barlesi F, Ederhy S, Thuny F. Clinical Features, Management, and Outcomes of Immune Checkpoint Inhibitor-Related Cardiotoxicity. Circulation. 2017 Nov 21;136(21):2085-2087. doi: 10.1161/CIRCULATIONAHA.117.030571. No abstract available.