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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04407247
The ClinicalTrials.gov registry entry for NCT04407247 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (93% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.