JAK Inhibitors for Solid Malignant Tumor Patients with Immune Checkpoint Inhibitors-related Dermatitis: a Open-lable, Single Arm, Phase IIa Trial

Phase 2

Not yet recruiting

• Conditions: Immune Checkpoint Inhibitors (ICI)-related Dermatitis
• Interventions: Drug: JAK Inhibitor

• Registration Number: NCT06715982
• Lead Sponsor: Shixiu Wu

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-22
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-28
• Last Update Submitted: 2024-11-28
• Study Start: 2024-12
• Study First Posted: 2024-12-04
• Last Update Posted: 2024-12-04
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 35

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
JAK inhibitors	JAK Inhibitor	treated with JAK inhibitors orally for 28 days

Primary Outcome Measures

Name	Time	Method
reduction in pruritus area and severity Index	at baseline, 7, 14 and 28 days.
safety of upadacitinib	at any time
global assessment (IGA)	at baseline, 7, 14 and 28 days

Secondary Outcome Measures

Name	Time	Method
quality index (DLQI)	at baseline, 7, 14 and 28 days.
pruritus score	at baseline, 7, 14 and 28 days.
Objective response rate	Baseline up to 6 months post last dose of upadacitinib	Will be measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as best response reported by the investigator at scans subsequent to upadacitinib therapy and will be obtained descriptively by chart review.
Progression-free survival	Baseline up to 6 months post last dose of upadacitinib	Will be obtained using RECIST 1.1 and obtained descriptively by chart review.
Continued ICIs utilization rate	at 28 days
The relapsed rate of ICI-related dermatitis	Baseline up to 6 months post last dose of upadacitinib

Trial Locations

Locations (1)

Quzhou people's hospital; 🇨🇳 Quzhou, Zhejiang, China