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NCT04407247 · ClinicalTrials.gov registry record · Phase 1
Infliximab or Vedolizumab in Treating Immune Checkpoint Inhibitor-Related Colitis in Patients With Genitourinary Cancer or Melanoma
A Phase 1 study of Melanoma and Malignant Solid Neoplasm, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
- 1
- Study location
NCT04407247: Active Phase 1 study of Melanoma and Malignant Solid Neoplasm, sponsored by M.D. Anderson Cancer Center.
NCT04407247 is a Phase 1 study of Melanoma and Malignant Solid Neoplasm that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 47 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04407247, a Phase 1 study of Melanoma and Malignant Solid Neoplasm, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial studies the side effects of infliximab and vedolizumab and to see how well they work in treating inflammation of the colon (colitis) caused by immune checkpoint inhibitor therapy in patients with cancer of the genital and urinary organs (genitourinary) or melanoma. Monoclonal antibodies, such as infliximab or vedolizumab, may help to treat immunotherapy induced colitis/diarrhea. This study may help to identify the optimal treatment strategy for immune checkpoint inhibitor-related colitis in patients with genitourinary cancer or melanoma.
Primary Outcome
The difference of the remission rate between standard of care (infliximab + corticosteroid) and the treatment with vedolizumab + corticosteroid will be calculated along with the 95% confidence interval.
Conditions Studied
Interventions
- BIOLOGICAL Infliximab
- BIOLOGICAL Vedolizumab
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2020-07-09 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What the registry record for NCT04407247 still lists
NCT04407247 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (93% lower).
The record links to 5 conditions, with Melanoma appearing as the primary indexed condition, and to 2 interventions - of which Infliximab is the first listed.
NCT04407247 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04407247 about?
NCT04407247 is a clinical study titled "Infliximab or Vedolizumab in Treating Immune Checkpoint Inhibitor-Related Colitis in Patients With Genitourinary Cancer or Melanoma". This phase I/II trial studies the side effects of infliximab and vedolizumab and to see how well they work in treating inflammation of the colon (colitis) caused by immune checkpoint inhibitor therapy in patients with cancer of the genital and urinary organs (genitourinary) or melanoma. Monoclonal a...
What is the current status of trial NCT04407247?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2020-07-09. Estimated completion is 2027-12-31.
What conditions does trial NCT04407247 study?
This clinical trial studies the following conditions: Melanoma, Malignant Solid Neoplasm, Lung Non-Small Cell Carcinoma, Malignant Genitourinary System Neoplasm, Colitis.
What interventions are being tested in trial NCT04407247?
The interventions under investigation include: Infliximab (BIOLOGICAL), Vedolizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04407247?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04407247 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Melanoma
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 NCT04407247's enrollment target sits among peer trials
47 170th of 266 higher than 97 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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