drugset / Trial / NCT04305145
Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis
Phase 2
Active not recruiting
42 enrolled
Massachusetts General Hospital
Dana-Farber Cancer Institute · collab
RandomizedCrossoverOpen-labelTreatment
Summary
The goal of this clinical trial is to compare the safety and effectiveness of infliximab compared to steroids for the treatment of immune checkpoint inhibitor-induced colitis (ICI colitis) in patients with stage III/IV skin cancer. The main questions this study aims to answer are: * How many patients treated with infliximab experience steroid-free disease resolution after 7 weeks? * How many patients treated with steroids experience steroid-free disease resolution after 7 weeks?
Timeline
- Start
- 2020-08-31
- Primary completion
- 2030-06-30
- Completion
- 2030-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Infliximab | Monoclonal antibody | — | Intravenous |
| Subject | Methylprednisolone | Other / unclassified | — | Intravenous |
| Subject | Prednisone | Other / unclassified | — | Oral |