← Back to Search

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
Age ≥ 18
Diagnosed with Stage III/IV skin cancer
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I have been diagnosed with advanced stage skin cancer.
Select...
I had severe diarrhea that stopped my immunotherapy treatment.
Select...
My screening showed visible signs of colitis.

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%
Change in urination
10%
Fatigue
10%
Heartburn
10%
Nausea
10%
Dizziness
10%
Itchiness
5%
Menstruation
5%
Pain in joints
5%
Migraine
5%
Stomach ache
5%
Syncope
5%
Chest pain
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
1,078 Previous Clinical Trials
340,830 Total Patients Enrolled
32 Trials studying Melanoma
2,868 Patients Enrolled for Melanoma
Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,313 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
~27 spots leftby Jun 2030