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Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis

NCT04305145 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-01-29

No results posted yet for this study

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?

Conditions

  • Melanoma Stage III
  • Melanoma Stage IV
  • Skin Cancer Stage III
  • Skin Cancer Stage IV
  • Drug-Induced Colitis
  • Drug Toxicity
  • Immune-related Adverse Event

Interventions

DRUG

Infliximab

Infusion

DRUG

Methylprednisolone

Infusion

DRUG

Prednisone

Orally

Sponsors & Collaborators

Principal Investigators

  • Michael Dougan, MD, PHD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-31
Primary Completion
2030-06-30
Completion
2030-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04305145 on ClinicalTrials.gov