RECRUITING

Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis

Conditions

Melanoma Stage III Melanoma Stage IV Skin Cancer Stage III Skin Cancer Stage IV Drug-Induced Colitis Drug Toxicity Immune-related Adverse Event Melanoma Skin cancer Colitis Immune checkpoint inhibitor Immunotherapy toxicity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to compare the safety and effectiveness of infliximab compared to steroids for the treatment of immune checkpoint inhibitor-induced colitis (ICI colitis) in patients with stage III/IV skin cancer. The main questions this study aims to answer are: * How many patients treated with infliximab experience steroid-free disease resolution after 7 weeks? * How many patients treated with steroids experience steroid-free disease resolution after 7 weeks?

Official Title

Phase II Study of Infliximab for the Treatment of Immune Checkpoint Inhibitor Colitis

Quick Facts

Study Start:2020-08-31

Study Completion:2030-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04305145

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age ≥ 18 * Stage III/IV skin cancer * Treatment with CTLA-4 inhibitor alone or in combination with PD-1or PD-L1 blockade within the past 8 weeks * Clinically significant diarrhea resulting in the decision to pause immunotherapy treatment * Endoscopically visible colitis (Mayo 1-3) at the time of screening	* Prior history of inflammatory colitis related to immune checkpoint inhibitors requiring treatment with \> 10 mg/day of prednisone or equivalent, or any other immunosuppressive medication * Concurrent immune-related Adverse Event (irAE) requiring treatment with systemic corticosteroids (dose equivalent of prednisone 10 mg/day or higher) or another systemic immune suppressing medication within the past 10 days * Current use of any immune suppressing biologic medication, or use within the last 4 weeks; immune stimulating medications such as checkpoint blockade are explicitly permitted * Current use of combination treatment with an investigation immunotherapy targeting a pathway other than PD-1 or PD-L1, concurrent chemotherapy, or targeted therapy * Previous adverse reaction to infliximab or corticosteroids * Colonic perforation or abscess present at the time of screening * History of Hepatitis B or C with a positive viral load, untreated mycobacterium tuberculosis, or active herpes zoster infection * Current bacterial infection requiring antibiotic treatment, or systemic fungal infection * Prior history of inflammatory bowel disease, microscopic colitis or segmental colitis associated with diverticulosis * Received more than 3 doses of systemic corticosteroids, or receive dsystemic corticosteroids at a dose exceeding 2mg/kg methylprednisolone or equivalent, within 72 hours prior to endoscopy

Inclusion Criteria

Exclusion Criteria

* Age ≥ 18
* Stage III/IV skin cancer
* Treatment with CTLA-4 inhibitor alone or in combination with PD-1or PD-L1 blockade within the past 8 weeks
* Clinically significant diarrhea resulting in the decision to pause immunotherapy treatment
* Endoscopically visible colitis (Mayo 1-3) at the time of screening

* Prior history of inflammatory colitis related to immune checkpoint inhibitors requiring treatment with \> 10 mg/day of prednisone or equivalent, or any other immunosuppressive medication
* Concurrent immune-related Adverse Event (irAE) requiring treatment with systemic corticosteroids (dose equivalent of prednisone 10 mg/day or higher) or another systemic immune suppressing medication within the past 10 days
* Current use of any immune suppressing biologic medication, or use within the last 4 weeks; immune stimulating medications such as checkpoint blockade are explicitly permitted
* Current use of combination treatment with an investigation immunotherapy targeting a pathway other than PD-1 or PD-L1, concurrent chemotherapy, or targeted therapy
* Previous adverse reaction to infliximab or corticosteroids
* Colonic perforation or abscess present at the time of screening
* History of Hepatitis B or C with a positive viral load, untreated mycobacterium tuberculosis, or active herpes zoster infection
* Current bacterial infection requiring antibiotic treatment, or systemic fungal infection
* Prior history of inflammatory bowel disease, microscopic colitis or segmental colitis associated with diverticulosis
* Received more than 3 doses of systemic corticosteroids, or receive dsystemic corticosteroids at a dose exceeding 2mg/kg methylprednisolone or equivalent, within 72 hours prior to endoscopy

Contacts and Locations

Study Contact

Michael Dougan, MD, PHD

CONTACT

617-726-3527

Michael_Dougan@DFCI.HARVARD.EDU

Keri Sullivan

CONTACT

617-724-0195

ksullivan79@mgh.harvard.edu

Principal Investigator

Michael Dougan, MD, PHD

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114

United States

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Michael Dougan, MD, PHD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-31

Study Completion Date2030-06-30

Study Record Updates

Study Start Date2020-08-31

Study Completion Date2030-06-30

Terms related to this study

Keywords Provided by Researchers

Melanoma
Skin cancer
Drug toxicity
Colitis
Immune checkpoint inhibitor
Immunotherapy toxicity
Immune-related adverse event

Additional Relevant MeSH Terms

Melanoma Stage III
Melanoma Stage IV
Skin Cancer Stage III
Skin Cancer Stage IV
Drug-Induced Colitis
Drug Toxicity
Immune-related Adverse Event