Infliximab for treating colitis caused by immune checkpoint inhibitors in skin cancer patients
Phase II Study of Infliximab for the Treatment of Immune Checkpoint Inhibitor Colitis
This study is testing whether infliximab can help skin cancer patients with colitis caused by their treatment feel better and avoid using steroids.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | infliximab, chemotherapy, immunotherapy, prednisone, ipilimumab |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT04305145 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and effectiveness of infliximab compared to steroids for treating immune checkpoint inhibitor-induced colitis in patients with stage III or IV skin cancer. It is a phase II, randomized trial that will assess how many patients achieve steroid-free disease resolution after 7 weeks of treatment. Participants will receive a CTLA-4 inhibitor, such as ipilimumab, and undergo flexible sigmoidoscopies or colonoscopies for clinical and research purposes. Blood samples will also be collected to support the study's findings.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with stage III or IV skin cancer who have experienced clinically significant diarrhea due to immune checkpoint inhibitors.
Not a fit: Patients with a prior history of inflammatory colitis requiring significant immunosuppressive treatment or those currently on systemic corticosteroids may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from colitis due to immune checkpoint inhibitors.
How similar studies have performed: Other studies have shown promise in using infliximab for similar conditions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts and 1 other locations
- Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States (Recruiting)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Michael Dougan, MD, PHD — Massachusetts General Hospital
- Study coordinator: Michael Dougan, MD, PHD
- Email: Michael_Dougan@DFCI.HARVARD.EDU
- Phone: 617-726-3527
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.