JAK inhibitor treatment for ICI-related dermatitis in people with solid tumors

JAK Inhibitors for Solid Malignant Tumor Patients With Immune Checkpoint Inhibitors-related Dermatitis: A Open-lable, Single Arm, Phase II Trial

This trial will try a JAK inhibitor to relieve severe immune checkpoint inhibitor-related dermatitis in adults with solid tumors and see if it is safe without harming cancer control.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Hangzhou Cancer Hospital (Academic / other)
• Locations: 1 site (Quzhou, Zhejiang)
• Trial ID: NCT06715982 on ClinicalTrials.gov

What this trial studies

This is an open-label, single-arm Phase IIa trial enrolling adults with solid malignant tumors who develop grade 3–4 dermatitis after treatment with FDA-approved CTLA-4, PD-1, or PD-L1 antibodies. Eligible participants may be steroid-naïve or have dermatitis refractory to corticosteroids or other immunosuppressants. Enrolled patients will receive a JAK inhibitor and be monitored for skin response, safety, and tolerability, with regular clinical and laboratory assessments. The trial has no control arm and focuses on short-term dermatologic outcomes and adverse events, with secondary attention to ongoing cancer therapy status.

Who should consider this trial

Good fit: Adults (≥18) with a confirmed solid malignant tumor who developed grade 3–4 ICI-related dermatitis after FDA-approved CTLA-4/PD-1/PD-L1 therapy and who meet required blood and organ function criteria are ideal candidates.

Not a fit: Patients with mild (grade 1–2) dermatitis, those with inadequate blood counts or organ function below the trial thresholds, or those with contraindications to JAK inhibitors are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, JAK inhibitors could quickly control severe ICI-related dermatitis while allowing patients to continue immunotherapy and possibly preserve or improve anti-tumor effects.

How similar studies have performed: Limited prior evidence from case reports and small series suggests JAK inhibitors can help steroid-refractory immune-related dermatitis, but randomized or large-scale data are lacking.

Eligibility criteria

Inclusion criteria:

1. Eligible patients must be at least 18 years of age with a confirmed diagnosis of a solid malignant tumor.
2. Patients who have received treatment with any Food and Drug Administration (FDA)-approved monoclonal antibodies targeting CTLA-4, PD-1, or PD-L1, either as monotherapy or in combination.
3. Patients who are diagnosed with Immune checkpoint inhibitors (ICI)-related dermatitis graded as 3-4 according to Common Terminology Criteria for Adverse Events Version 5.0.
4. Patients with ICI-related dermatitis who were either treatment-naïve (having received no prior steroids or immunosuppressants) or were refractory to previous treatment with corticosteroids and/or immunosuppressive agents.
5. Adequate bone marrow and organ function, as outlined below, must be confirmed:

1\) White blood cell (WBC) count ≥ 2.0 × 10⁹/L 2) Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L 3) Platelet count (PLT) ≥ 75 × 10⁹/L 4) Hemoglobin (Hgb) ≥ 90 g/L 5) AST and ALT ≤ 3 × upper limit of normal (ULN) in patients without hepatic metastases; ≤ 5 × ULN in those with hepatic metastases, provided the elevation is not attributable to ICI-related hepatitis 6) Total bilirubin ≤ 2 × ULN, except in cases of Gilbert's syndrome (where total bilirubin must be \< 3.0 mg/dL), and not due to ICI-related hepatotoxicity

6\. All participants must be capable of providing personally signed and dated informed consent, demonstrating understanding of all relevant study aspects.

Exclusion criteria:

1. Patients with dermatological diseases (e.g., chronic inflammatory skin disorders such as atopic dermatitis or psoriasis) that, in the investigator's assessment, may elevate the risks associated with study participation or compromise the interpretation of study outcomes.
2. Patients who currently present with persistent dermatitis (grade \>1, according to CTCAE v5.0) attributable to therapeutic interventions other than ICIs treatment.
3. Female who is pregnant, breastfeeding, or considering pregnancy during the study.
4. Current or past history of infection including herpes zoster or herpes simplex, human immunodeficiency virus (HIV), active Tuberculosis, active or chronic recurring infection, active hepatitis B or C.
5. Any other medical, psychiatric, or logistical condition that, in the judgment of the investigator, could pose a safety risk, affect protocol compliance, or interfere with the conduct or interpretability of the study.

Where this trial is running

Quzhou, Zhejiang

• Quzhou people's hospital — Quzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Shixiu Wu

Conditions Immune Checkpoint Inhibitors-Related Dermatitis; immune checkpoint inhibitors-related dermatitis; Janus kinase inhibitors