Itacitinib for the Treatment Steroid Refractory Immune Related Adverse Events Arising From Immune Checkpoint Inhibitors

Sponsor
Douglas Johnson
Study ID
NCT05660421
Phase
PHASE2
Status
Withdrawn

Conditions

  • Hematopoietic and Lymphoid Cell Neoplasm
  • Malignant Solid Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Itacitinib — DRUG
    Given by mouth
  • Corticosteroid — DRUG
    Given by mouth or by vein
  • Endoscopic Procedure — PROCEDURE
    Undergo endoscopic procedure
  • Skin biopsy — PROCEDURE
    Undergo skin biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood and stool

Study Details

This phase II trial tests how well itacitinib works in in patients with immune related adverse events (irAEs) arising from immune checkpoint inhibitors (ICI) that do not respond to steroids (steroid refractory). Steroids are the usual treatment for these side effects. However, sometimes steroids do not improve or fix the side effects. Giving itacitinib may be effective in treating patients with known or suspected problems coming from ICIs, that do not resolve or improve with steroids, by reducing the patients immune system response that can cause the irAEs.

Key Dates

Start date
Mar 3, 2023
Status verified
Apr 2026
Primary completion
Apr 3, 2025
Completion
Apr 3, 2025

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (itacitinib)
    Patients receive itacitinib PO and corticosteroids PO or IV. Patients may undergo endoscopy and skin biopsy throughout the study. Patients also undergo blood collection throughout the study.

Primary Outcome Measure

Incidence of immune related adverse events (irAE) [ Time Frame: Baseline up to 60 days post last dose of itacitinib ]

Related Studies