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

Phase 2

Not yet recruiting

• Conditions: Glucocorticoid Resistant ICIs-related Myocarditis
• Interventions: Drug: Tofacitinib 5 MG BID

• Registration Number: NCT06393972
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-23
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-26
• Last Update Submitted: 2024-04-26
• Study First Posted: 2024-05-01
• Last Update Posted: 2024-05-01
• Study Start: 2024-07-01
• Primary Completion: 2025-11-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tofacitinib	Tofacitinib 5 MG BID	Tofacitinib in patients with glucocorticoid resistant ICIs-related myocarditis

Primary Outcome Measures

Name	Time	Method
All-cause mortality within three months	The first three months after tofacitinib administration	All-cause mortality within three months

Secondary Outcome Measures

Name	Time	Method
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
Overall survival	From date of enrollment until the date of death from any cause, assessed up to 24 months"	Overall survival
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
All-cause mortality within six months	The firs six months after tofacitinib administration	All-cause mortality within six months