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Monoclonal Antibodies

Infliximab for 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

Study 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 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

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%

Change in urination

10%

Heartburn

10%

Fatigue

10%

Nausea

10%

Dizziness

10%

Itchiness

Menstruation

Pain in joints

Migraine

Stomach ache

Syncope

Chest pain

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

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteOTHER

1,079 Previous Clinical Trials

340,944 Total Patients Enrolled

32 Trials studying Melanoma

2,868 Patients Enrolled for Melanoma

Massachusetts General HospitalLead Sponsor

2,933 Previous Clinical Trials

13,198,459 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What has been the Food and Drug Administration's opinion on Infliximab?

"According to our evaluation, Infliximab was assigned a safety score of 2 due to the fact that only preliminary data points towards its efficacy and there is some evidence for its security."

Answered by AI

To what medical issues is Infliximab typically administered as a treatment?

"Infliximab is widely accepted as a viable treatment for ulcerative colitis, yet its impact can also be seen in patients with varicella-zoster virus acute retinal necrosis, crohn disease, and tuberculous meningitis."

Answered by AI

How many individuals are being recruited for participation in this research?

"Affirmative. According to clinicaltrials.gov, this experiment was posted on August 31st 2020 and has been actively seeking participants since then. Consequently, the team is looking for 42 patients from two distinct medical centres."

Answered by AI

Is this experiment currently enrolling test subjects?

"Affirmative. Clinicaltrials.gov declares that this medical trial is actively enrolling participants since its initial posting on August 31st, 2020; the study was recently amended as of October 26th, 2021 and requires 42 volunteers from two different locations."

Answered by AI

What have been the past findings related to Infliximab research?

"At this current moment in time, 450 clinical trials are taking place researching Infliximab. Of these active investigations, 122 have advanced to Phase 3 status. The bulk of the research is occurring in Duarte, California; however, 17762 medical locations across the globe are running tests for this treatment option."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis

Michael Dougan 2020. "Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04305145.

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