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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: Active Phase 2 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma, sponsored by M.D. Anderson Cancer Center.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Defined as the rate of confirmed complete responses + partial responses as determined by Response Evaluation Criteria in Solid Tumors 1.1 criteria and as assessed by the investigator. In addition, will also calculate the posterior probability that ORR is bigger in CXCL13 high group than in the CXCL low group.

Conditions Studied

Metastatic Urothelial Carcinoma Locally Advanced Urothelial Carcinoma Metastatic Bladder Urothelial Carcinoma Locally Advanced Bladder Urothelial Carcinoma Metastatic Ureter Urothelial Carcinoma Metastatic Urethral Urothelial Carcinoma Locally Advanced Ureter Urothelial Carcinoma Metastatic Renal Pelvis Urothelial Carcinoma Locally Advanced Renal Pelvis Urothelial Carcinoma Locally Advanced Urethral Urothelial Carcinoma

Interventions

  • DRUG Relatlimab
  • BIOLOGICAL Nivolumab
  • OTHER Diagnostic Laboratory Biomarker Analysis

Study Locations (1)

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2021-09-21
Est. Completion 2026-12-31
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

What the registry record for NCT04953104 still lists

NCT04953104 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 131-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (95% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Metastatic Urothelial Carcinoma

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 NCT04953104's enrollment target sits among peer trials

6 29th of 30 higher than 1 of 30 other Metastatic Urothelial Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Metastatic Urothelial Carcinoma 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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Related registry views

Source: ClinicalTrials.gov NCT04953104, the US trial registry maintained by the National Library of Medicine. NCT04953104 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.