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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

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

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 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%

Nausea

10%

Change in urination

10%

Heartburn

10%

Fatigue

10%

Dizziness

10%

Itchiness

Pain in joints

Chest pain

Stomach ache

Syncope

Menstruation

Migraine

Swelling

Bloody stool

Pain in leg

Allergies

Change in blood pressure

Vertigo

Change in appetite

Numbness

Motor vehicle accident

100%

80%

60%

40%

20%

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

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