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

NCT ID: NCT06393972

Last Updated: 2024-05-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2026-11-30

Brief Summary

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

Conditions

Glucocorticoid Resistant ICIs-related Myocarditis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tofacitinib

Tofacitinib in patients with glucocorticoid resistant ICIs-related myocarditis

Group Type: EXPERIMENTAL

Tofacitinib 5 MG BID

Intervention Type: DRUG

Tofacitinib 5 MG BID

Interventions

Tofacitinib 5 MG BID

Tofacitinib 5 MG BID

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tianshu Liu

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Yan Wang

Role: CONTACT

wang.yan@zs-hospital.sh.cn

+86-21-64041990

Other Identifiers

ZSLCYJ202353

Identifier Type: -

Identifier Source: org_study_id