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NCT04305145 · ClinicalTrials.gov registry record · Phase 2
Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis
A Phase 2 study of Melanoma Stage IV and Melanoma Stage III, sponsored by Massachusetts General Hospital.
- Active
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
- 2
- Study locations
NCT04305145: Active Phase 2 study of Melanoma Stage IV and Melanoma Stage III, sponsored by Massachusetts General Hospital.
NCT04305145 is a Phase 2 study of Melanoma Stage IV and Melanoma Stage III that is active but no longer recruiting, run by Massachusetts General Hospital. The registered enrollment target is 42 participants, below the 100-participant average among 17 other Melanoma Stage IV trials with a reported enrollment target (58% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04305145, a Phase 2 study of Melanoma Stage IV and Melanoma Stage III, is active but no longer recruiting, sponsored by Massachusetts General Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
- 2
- Study locations
Study 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 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?
Primary Outcome
Proportion of Patients with Steroid-Free Colitis at seven weeks with steroid-free colitis remission defined as less than 7.5 mg a day of prednisone or equivalent and grade-1 or lower symptoms.
Conditions Studied
Interventions
- DRUG Prednisone
- DRUG Methylprednisolone
- DRUG Infliximab
Study Locations (2)
Massachusetts
- Massachusetts General Hospital Cancer Center - Boston
- Dana-Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2020-08-31 |
| Est. Completion | 2030-06-30 |
| Phase | Phase 2 |
What the registry record for NCT04305145 still lists
NCT04305145 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 100-participant average among 17 other Melanoma Stage IV trials with a reported enrollment target (58% lower).
The record links to 7 conditions, with Melanoma Stage IV appearing as the primary indexed condition, and to 3 interventions - of which Prednisone is the first listed.
NCT04305145 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04305145 about?
NCT04305145 is a clinical study titled "Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis". 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 patie...
What is the current status of trial NCT04305145?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2020-08-31. Estimated completion is 2030-06-30.
What conditions does trial NCT04305145 study?
This clinical trial studies the following conditions: Melanoma Stage IV, Melanoma Stage III, Drug Toxicity, Skin Cancer Stage III, Skin Cancer Stage IV.
What interventions are being tested in trial NCT04305145?
The interventions under investigation include: Prednisone (DRUG), Methylprednisolone (DRUG), Infliximab (DRUG).
Who is sponsoring clinical trial NCT04305145?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04305145 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04305145's enrollment target sits among peer trials
42 13th of 17 higher than 5 of 17 other Melanoma Stage IV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma Stage IV trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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