Phase II Study of Infliximab for the Treatment of Immune Checkpoint Inhibitor Colitis

Who is this study for? Patients with Melanoma
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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?

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18

• Stage III/IV skin cancer

• Treatment with CTLA-4 inhibitor alone or in combination with PD-1or PD-L1 blockade within the past 8 weeks

• Clinically significant diarrhea resulting in the decision to pause immunotherapy treatment

• Endoscopically visible colitis (Mayo 1-3) at the time of screening

Locations
United States
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
Massachusetts General Hospital Cancer Center
RECRUITING
Boston
Contact Information
Primary
Michael Dougan, MD, PHD
Michael_Dougan@DFCI.HARVARD.EDU
617-726-3527
Backup
Keri Sullivan
ksullivan79@mgh.harvard.edu
617-724-0195
Time Frame
Start Date: 2020-08-31
Estimated Completion Date: 2030-06-30
Participants
Target number of participants: 42
Treatments
Experimental: Infliximab
Patients randomized to this arm will receive IV infliximab regardless of whether they are hospitalized due to their colitis.~* Infliximab: Predetermined dose of intravenous infliximab, up to 3 times over 7 weeks~* Crossover for inadequate response: Patients who do not respond to initial treatment within 3 days with a decrease in symptoms by one grade, or who do not improve to grade 2 or less symptoms by 5 days will add combination therapy from the other treatment arm (corticosteroids) at full initial dosing.
Experimental: Corticosteroids
Patients randomized to this arm will receive IV steroids or oral steroids depending on whether the severity of their colitis requires hospitalization (inpatient).~* Inpatient: Predetermined intravenous dose of methylprednisolone, 2x daily up until patients can safely be transitioned to an oral prednisone taper~* Outpatient: Predetermined oral dose of predisone, daily over 7 weeks~Crossover for inadequate response: Patients who do not respond to initial treatment within 3 days with a decrease in symptoms by one grade, or who do not improve to grade 2 or less symptoms by 5 days will add combination therapy from the other treatment arm (infliximab) at full initial dosing.
Related Therapeutic Areas
Sponsors
Collaborators: Dana-Farber Cancer Institute
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov