Not yet recruiting NCT06393972

The Efficacy and Safety of Tofacitinib in Patients With Glucocorticoid Resistant ICIs-related Myocarditis

Phase II Interventional Glucocorticoid Resistant ICIs-related Myocarditis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Tofacitinib 5 MG BID.
Who it may be relevant to: Registry conditions: Glucocorticoid Resistant ICIs-related Myocarditis. Basic parameters: 18 years — 85 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

The Efficacy and Safety of Tofacitinib in Patients With Glucocorticoid Resistant ICIs-related Myocarditis: a Single-arm, Prospective, Phase 2 Trial

The efficacy and safety of Tofacitinib in patients with glucocorticoid resistant ICIs-related myocarditis: a single-arm, prospective, phase 2 trial

All-cause mortality within three months [Time frame: The first three months after tofacitinib administration]

Secondary outcome measures (4)

All-cause mortality within six months [Time frame: The firs six months after tofacitinib administration]
Progression-free survival [Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months]
Overall survival [Time frame: From date of enrollment until the date of death from any cause, assessed up to 24 months"]
Safety and tolerability based on incidence of treatment-emergent adverse events [Time frame: through study completion, an average of 1 year]

Age ≥ 18 years old
Patients treated with ICI immunotherapy (monotherapy or combination), including anti-PD1, anti-PDL1, anti-CTLA4; and including any type of cancer (even those in which ICI is not currently approved by regulatory)
Definite, probable or possible ICI-induced myocarditis according to the diagnostic criteria of the most recent expert consensus recommendations (e.g27, to be updated with any new recommendations to be published)
corticosteroid-resistant ICI-myocarditis: Corticosteroid-resistant ICI-myocarditis is defined by the absence of decrease in troponin levels or the appearance/persistence of severity criteria despite receiving prednisone dose ≥0.5 mg/kg/day for ≥2 days.
Signature of informed consent before any trial procedure from the patient or legal representative or the close relative
Patients covered by social security regimen (excepting AME)
Withhold of ICI

Untreated and/or uncontrolled bacterial, fungal, or viral infection Pregnancy, breast-feeding or planning to become pregnant during the study period
For women of childbearing age, lack of effective contraception throughout the duration of participation in the study
Being treated with tofacitinib within 3 months prior to inclusion Known hypersensitivity to abatacept or belatacept
Being treated with anti-thymoglobulin, or alemtuzumab within 6 weeks of the first scheduled dose of abatacept
Patient participating to another interventional study (RIPH 1 only) People under legal protection measure (tutorship, curatorship or safeguard measures)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Center list to be confirmed — check the primary protocol.

NCT: NCT06393972 · ZSLCYJ202353