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

Phase 2Not Yet RecruitingNCT06393972

Shanghai Zhongshan Hospital25 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glucocorticoid Resistant ICIs-related Myocarditis

Interventions

Tofacitinib 5 MG BIDDRUG

Tofacitinib 5 MG BID

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

All-cause mortality within three months

Time frame: The first three months after tofacitinib administration

Secondary Outcomes

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

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Time frame: through study completion, an average of 1 year

Central Contacts

Yan Wang

CONTACT

+86-21-64041990 wang.yan@zs-hospital.sh.cn

Data from ClinicalTrials.gov

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