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NCT Number: NCT06393972

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

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

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Key information

Conditions

Glucocorticoid Resistant ICIs-related Myocarditis

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years old
  • 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)
  • 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)
  • 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.
  • Signature of informed consent before any trial procedure from the patient or legal representative or the close relative
  • Patients covered by social security regimen (excepting AME)
  • Withhold of ICI

Exclusion criteria

  • Untreated and/or uncontrolled bacterial, fungal, or viral infection Pregnancy, breast-feeding or planning to become pregnant during the study period
  • For women of childbearing age, lack of effective contraception throughout the duration of participation in the study
  • Being treated with tofacitinib within 3 months prior to inclusion Known hypersensitivity to abatacept or belatacept
  • Being treated with anti-thymoglobulin, or alemtuzumab within 6 weeks of the first scheduled dose of abatacept
  • Patient participating to another interventional study (RIPH 1 only) People under legal protection measure (tutorship, curatorship or safeguard measures)

Treatment and study plan

Tofacitinib 5 MG BID

Drug

Tofacitinib 5 MG BID

Primary outcomes

  1. All-cause mortality within three months

    Time frame: The first three months after tofacitinib administration

    All-cause mortality within three months

Secondary outcomes

  1. All-cause mortality within six months

    Time frame: The firs six months after tofacitinib administration

    All-cause mortality within six months

  2. 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

    Progression-free survival

  3. Overall survival

    Time frame: From date of enrollment until the date of death from any cause, assessed up to 24 months"

    Overall survival

  4. Safety and tolerability based on incidence of treatment-emergent adverse events

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Yan Wang

CONTACT

[email protected]

+86-21-64041990

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

The Efficacy and Safety of Tofacitinib in Patients With Glucocorticoid Resistant ICIs-related Myocarditis: a Single-arm, Prospective, Phase 2 Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 1, 2024
Registry last updated
May 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.