Clinical trial NCT06393972: The Efficacy and Safety of Tofacitinib in Patients With Glucocorticoid Resistant ICIs-related Myocarditis
Official title: The Efficacy and Safety of Tofacitinib in Patients With Glucocorticoid Resistant ICIs-related Myocarditis: a Single-arm, Prospective, Phase 2 Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Glucocorticoid Resistant ICIs-related Myocarditis
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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)

Primary outcomes:
measure: All-cause mortality within three months
timeFrame: The first three months after tofacitinib administration
Secondary outcomes:
measure: All-cause mortality within six months
timeFrame: The firs six months after tofacitinib administration
measure: Progression-free survival
timeFrame: 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
measure: Overall survival
timeFrame: From date of enrollment until the date of death from any cause, assessed up to 24 months"
measure: Safety and tolerability based on incidence of treatment-emergent adverse events
timeFrame: through study completion, an average of 1 year
Other outcomes:
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