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NCT04953104 · ClinicalTrials.gov registry record · Phase 2
ARID1A and/or KDM6A Mutation and CXCL13 Expression
A Phase 2 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT04953104 is a Phase 2 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 6 participants, below the 131-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04953104, a Phase 2 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies the effect of nivolumab in urothelial cancer that has spread to other places in the body (metastatic), specifically in patients with aberrations in ARID1A gene (ARID1A mutation) and correlate with expression level of CXCL13, an immune cytokine. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab may help control the disease in patients with urothelial cancer or solid tumors. This trial aims at enriching patient selection based on genomic and immunological attributes of the tumor.
Conditions Studied
Interventions
- DRUG Relatlimab
- BIOLOGICAL Nivolumab
- OTHER Diagnostic Laboratory Biomarker Analysis
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2021-09-21 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04953104
The ClinicalTrials.gov registry entry for NCT04953104 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 131-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (95% 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 10 conditions, with Metastatic Urothelial Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Relatlimab is the first listed.
NCT04953104 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT04953104 about?
NCT04953104 is a clinical study titled "ARID1A and/or KDM6A Mutation and CXCL13 Expression". This phase II trial studies the effect of nivolumab in urothelial cancer that has spread to other places in the body (metastatic), specifically in patients with aberrations in ARID1A gene (ARID1A mutation) and correlate with expression level of CXCL13, an immune cytokine. Immunotherapy with monoclon...
What is the current status of trial NCT04953104?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2021-09-21. Estimated completion is 2026-12-31.
What conditions does trial NCT04953104 study?
This clinical trial studies the following conditions: Metastatic Urothelial Carcinoma, Locally Advanced Urothelial Carcinoma, Metastatic Bladder Urothelial Carcinoma, Locally Advanced Bladder Urothelial Carcinoma, Metastatic Ureter Urothelial Carcinoma.
What interventions are being tested in trial NCT04953104?
The interventions under investigation include: Relatlimab (DRUG), Nivolumab (BIOLOGICAL), Diagnostic Laboratory Biomarker Analysis (OTHER).
Who is sponsoring clinical trial NCT04953104?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04953104 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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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.