Can a rheumatoid arthritis drug tame immunotherapy side effects?
NCT ID NCT04305145
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether infliximab, a drug used for inflammatory conditions, can treat colitis (colon inflammation) caused by immune checkpoint inhibitors in people with stage III or IV skin cancer. About 42 participants will receive either infliximab or steroids, and researchers will compare how many achieve symptom relief without needing long-term steroids after 7 weeks. The goal is to find a safer, more effective way to manage this common side effect.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- infliximab (a drug that blocks inflammation)
- What this could lead to
- If it works, this could offer a more effective, steroid-free way to manage severe colitis caused by immunotherapy, allowing patients to better tolerate cancer treatment.
- What could go wrong
- This is a small, early-phase trial with only 42 participants. Infliximab may not work better than steroids, and it carries risks like infection or allergic reactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Aug 2020
- Expected to finish
-
Jun 2030
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion 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 Exclusion Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
-
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
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Other studies related to the condition(s) this trial covers.
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