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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
All Individual Drugs Already Approved
Approved for 50 Other Conditions
No Placebo-Only Group
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.
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ the duration of time from start of randomization to time of death or up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the duration of time from start of randomization to time of death or up to 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of patients with Steroid-Free Colitis
Secondary study objectives
Cumulative steroid exposure
Overall Response Rate
Overall Survival
+8 moreSide effects data
From 2020 Phase 4 trial • 42 Patients • NCT0300639352%
Laceration
38%
Headache
24%
Bruises
19%
Sore throat
14%
Muscle tension
10%
Nausea
10%
Change in urination
10%
Heartburn
10%
Fatigue
10%
Dizziness
10%
Itchiness
5%
Pain in joints
5%
Chest pain
5%
Stomach ache
5%
Syncope
5%
Menstruation
5%
Migraine
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
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 50 Other Conditions
This treatment demonstrated efficacy for 50 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Methylprednisolone hemisuccinate
FDA approved
Prednisone
FDA approved
Infliximab
FDA approved
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteOTHER
1,113 Previous Clinical Trials
358,707 Total Patients Enrolled
32 Trials studying Melanoma
2,836 Patients Enrolled for Melanoma
Massachusetts General HospitalLead Sponsor
3,026 Previous Clinical Trials
13,413,769 Total Patients Enrolled
22 Trials studying Melanoma
1,071 Patients Enrolled for Melanoma
Michael Dougan, MD, PHDPrincipal Investigator - Massachusetts General Hospital
Massachusetts General Hospital, Massachusetts General Physicians Organization Inc