Status:
RECRUITING
Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Dana-Farber Cancer Institute
Conditions:
Melanoma Stage III
Melanoma Stage IV
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
This is a phase II, randomized, signal-detection trial to evaluate the efficacy and safety of the drugs infliximab, methylprednisolone, and prednisone to manage the side of effect of colitis caused by...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2030
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04305145
Start Date
August 31 2020
End Date
June 30 2030
Last Update
September 22 2025
Active Locations (2)
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1
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215