← Back to Search

Monoclonal Antibodies

Infliximab for Colitis in Melanoma

Phase 2
Recruiting
Led By Michael Dougan, MD, PHD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the duration of time from start of randomization to time of death or up to 24 months
Awards & highlights

Summary

This trial is testing a new treatment for colitis caused by ipilimumab in people with advanced melanoma.

Who is the study for?
This trial is for adults over 18 with stage III/IV melanoma who've had recent treatment with specific immune therapies and are experiencing moderate to severe diarrhea as a side effect. It's not for those on other immune suppressants, have certain infections or hepatitis, inflammatory bowel diseases, or previous bad reactions to infliximab or steroids.Check my eligibility
What is being tested?
The study compares infliximab against steroids in treating colitis caused by cancer immunotherapy. Participants will be randomly assigned to receive either infliximab or steroids and monitored for steroid-free disease resolution after 7 weeks.See study design
What are the potential side effects?
Infliximab may cause infusion-related reactions, risk of infection, potential liver issues, and could worsen heart failure. Steroids can lead to increased appetite, mood changes, high blood pressure, bone weakening over time and raise the risk of infections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the duration of time from start of randomization to time of death or up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and the duration of time from start of randomization to time of death or up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients with Steroid-Free Colitis
Secondary outcome measures
Cumulative steroid exposure
Overall Response Rate
Overall Survival
+8 more

Side effects data

From 2020 Phase 4 trial • 42 Patients • NCT03006393
52%
Laceration
38%
Headache
24%
Bruises
19%
Sore throat
14%
Muscle tension
10%
Fatigue
10%
Change in urination
10%
Heartburn
10%
Nausea
10%
Dizziness
10%
Itchiness
5%
Migraine
5%
Menstruation
5%
Pain in joints
5%
Syncope
5%
Chest pain
5%
Stomach ache
5%
Swelling
5%
Bloody stool
5%
Pain in leg
5%
Allergies
5%
Change in blood pressure
5%
Vertigo
5%
Change in appetite
5%
Numbness
5%
Motor vehicle accident
100%
80%
60%
40%
20%
0%
Study treatment Arm
Infliximab
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Group I: InfliximabExperimental Treatment1 Intervention
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.
Group II: CorticosteroidsExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Infliximab
FDA approved
Methylprednisolone hemisuccinate
FDA approved
Prednisone
FDA approved

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteOTHER
1,085 Previous Clinical Trials
341,738 Total Patients Enrolled
32 Trials studying Melanoma
2,868 Patients Enrolled for Melanoma
Massachusetts General HospitalLead Sponsor
2,955 Previous Clinical Trials
13,212,636 Total Patients Enrolled
22 Trials studying Melanoma
1,057 Patients Enrolled for Melanoma
Michael Dougan, MD, PHDPrincipal Investigator - Massachusetts General Hospital
Massachusetts General Hospital, Massachusetts General Physicians Organization Inc
~25 spots leftby Jun 2030
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top