Glucocorticoid Resistant ICIs-related Myocarditis
Conditions
Brief summary
The efficacy and safety of Tofacitinib in patients with glucocorticoid resistant ICIs-related myocarditis: a single-arm, prospective, phase 2 trial
Interventions
Tofacitinib 5 MG BID
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality within three months | The first three months after tofacitinib administration | All-cause mortality within three months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality within six months | The firs six months after tofacitinib administration | All-cause mortality within six months |
| Progression-free survival | 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 | Progression-free survival |
| Overall survival | From date of enrollment until the date of death from any cause, assessed up to 24 months | Overall survival |
| Safety and tolerability based on incidence of treatment-emergent adverse events | through study completion, an average of 1 year | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |
Contacts
Primary ContactYan Wang
Outcome results
None listed