Clinical trial NCT06715982: JAK Inhibitors for Solid Malignant Tumor Patients with Immune Checkpoint Inhibitors-related Dermatitis: a Open-lable, Single Arm, Phase IIa Trial
Official title: JAK Inhibitors for Solid Malignant Tumor Patients with Immune Checkpoint Inhibitors-related Dermatitis: a Open-lable, Single Arm, Phase II Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Immune Checkpoint Inhibitors (ICI)-related Dermatitis
Keywords: immune checkpoint inhibitors (ICI)-related dermatitis
Janus kinase inhibitors
Lead sponsor: Hangzhou Cancer Hospital
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Currently, the principal strategy for immune checkpoint inhibitors (ICI)-related dermatitis include systemic use of corticosteroids, which can impair the efficacy of preceding ICIs treatment. Janus kinase inhibitors (JAKi) could be the optimal option for ICI-related dermatitis, which can not only provide rapid relief for ICI-related dermatitis but also potentially enhance the anti-tumor efficacy of ICIs. This is an open-lable, single arm, phase II trial, aims to evaluate efficacy and safety of JAK inhibitors for solid malignant tumor patients with ICI-related dermatitis.


Eligibility criteria: Inclusion Criteria:

* Patients receiving treatment with any of the Food and Drug Administration (FDA) approved monoclonal antibodies that block CTLA-4, PD-1, PD-L1, or any combination.

Patients recommended to undergo skin biopsy due to a clinical diagnosis of ICI-induced dermatitis as part of routine and standard clinical care are eligible.

May have been treated with additional steroids or immunomodulators (one or more) prior to study entry (e.g. infliximab, mycophenolate mofetil, intravenous immunoglobulin), provided such immunomodulators are discontinued prior to first dose of study therapy.

Patients must be age 18 or older. Patients diagnosed with solid malignant tumor. Eastern Cooperative Oncology Group (ECOG) performance status \< 2. Measurable disease as per RECIST 1.1 Patients must be able to personally sign and date informed consent indicating that the patient has been informed of all pertinent aspects of the study are eligible.

Adequate organ and marrow function as defined below:

White blood cell (WBC) ≥ 2.0 ×109/L. Neutrophil (ANC) ≥ 1.5 ×109/L. Platelet (PLT) ≥ 75 ×109/L. Hemoglobin (Hgb) ≥ 8.0 g/dL. AST and ALT ≤ 3 x ULN in subjects without hepatic metastases; AST and ALT ≤ 5 x ULN in subjects with hepatic metastases, if AST/ALT elevation is NOT due to ICI-induced hepatitis.

Total bilirubin ≤ 2 x ULN not due to ICI-hepatitis (except subjects with Gilbert syndrome, where total bilirubin must be \< 3.0 mg/dL).

Exclusion Criteria:

* Patients taking antibiotics or who plan to begin taking antibiotics Known medical condition (e.g. a disease associated with chronic skin inflammation such as atopic dermatitis or psoriasis) that, in the investigator's opinion, would increase the risk associated with study participation or interfere with the interpretation of results Not recovered to non-dermatologic =\< grade 1 toxicities related to any prior therapy Pregnant woman Patients with human immunodeficiency virus (HIV), hepatitis B, or C will be excluded from this study Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures (including compliance issues related to feasibility/logistics)

Primary outcomes:
measure: reduction in pruritus area and severity Index
timeFrame: at baseline, 7, 14 and 28 days.
measure: safety of upadacitinib
timeFrame: at any time
measure: global assessment (IGA)
timeFrame: at baseline, 7, 14 and 28 days
Secondary outcomes:
measure: quality index (DLQI)
timeFrame: at baseline, 7, 14 and 28 days.
measure: pruritus score
timeFrame: at baseline, 7, 14 and 28 days.
measure: Objective response rate
timeFrame: Baseline up to 6 months post last dose of upadacitinib
measure: Progression-free survival
timeFrame: Baseline up to 6 months post last dose of upadacitinib
measure: Continued ICIs utilization rate
timeFrame: at 28 days
measure: The relapsed rate of ICI-related dermatitis
timeFrame: Baseline up to 6 months post last dose of upadacitinib
Other outcomes:
Locations:
city: Quzhou
country: China
facility: Quzhou people's hospital
state: Zhejiang
Study officials:
References: