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

Fudan University

Status and phase: Not yet enrolling; Phase 2

Conditions: Glucocorticoid Resistant ICIs-related Myocarditis

Treatments: Drug: Tofacitinib 5 MG BID

Study type: Interventional

Funder types: Other

Identifiers

NCT06393972

ZSLCYJ202353

Details and patient eligibility

About

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

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years old
2. 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)
3. 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)
4. 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.
5. Signature of informed consent before any trial procedure from the patient or legal representative or the close relative
6. Patients covered by social security regimen (excepting AME)
7. Withhold of ICI

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Tofacitinib

Experimental group

Description:

Tofacitinib in patients with glucocorticoid resistant ICIs-related myocarditis

Treatment:

Drug: Tofacitinib 5 MG BID