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NCT06414590 · ClinicalTrials.gov registry record · Phase 2

Neoadjuvant Tebentafusp for Uveal Melanoma

A Phase 2 study of Locally Advanced Unresectable Uveal Melanoma, sponsored by Thomas Jefferson University.

Recruiting
Registry status
Phase 2
Development phase
19
Enrollment target
2
Study locations

NCT06414590: Recruiting Phase 2 study of Locally Advanced Unresectable Uveal Melanoma, sponsored by Thomas Jefferson University.

NCT06414590 is a Phase 2 study of Locally Advanced Unresectable Uveal Melanoma that is actively recruiting participants, run by Thomas Jefferson University. The registered enrollment target is 19 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06414590, a Phase 2 study of Locally Advanced Unresectable Uveal Melanoma, is actively recruiting participants, sponsored by Thomas Jefferson University.

RECRUITING
Registry status
Phase 2
Development phase
19 participants
Enrollment target
2
Study locations

Study Summary

This phase II trial tests how well tebentafusp works to shrink tumors prior to primary treatment with surgery or radiation in patients with uveal (eye) melanoma that has spread to nearby tissue or lymph nodes (locally advanced) or that cannot be removed by surgery (unresectable). Tebentafusp is a drug that binds to melanoma tumor cells as well as immune cells called T-cells. This binding causes an immune response against the melanoma cells, which leads to tumor cell death. Tebentafusp has been approved for the treatment of locally advanced and unresectable uveal melanoma. Giving tebentafusp before primary treatment with surgery or radiation may help shrink the tumor, prevent the disease from spreading, or reduce the likelihood that patients will require total eye removal (called enucleation).

Primary Outcome

Regression is defined as ≥ 20% reduction in tumor volume. All estimates of rates will be presented with corresponding 95% exact confidence intervals. For regression rate, the method of Atkinson and Brown will be used to allow for the two-stage design.

Interventions

  • DRUG Tebentafusp-Tebn

Study Locations (2)

Pennsylvania

  • Sidney Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
  • Wills Eye Hospital - Philadelphia

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2025-09-05
Est. Completion 2032-03
Phase Phase 2
Thomas Jefferson University

292 total trials

What NCT06414590 shows while recruiting

NCT06414590 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).

The record links to 1 condition, with Locally Advanced Unresectable Uveal Melanoma appearing as the primary indexed condition, and to 1 intervention - of which Tebentafusp-Tebn is the first listed.

NCT06414590 reports a single indexed study location in Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT06414590 about?

NCT06414590 is a clinical study titled "Neoadjuvant Tebentafusp for Uveal Melanoma". This phase II trial tests how well tebentafusp works to shrink tumors prior to primary treatment with surgery or radiation in patients with uveal (eye) melanoma that has spread to nearby tissue or lymph nodes (locally advanced) or that cannot be removed by surgery (unresectable). Tebentafusp is a dr...

What is the current status of trial NCT06414590?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2025-09-05. Estimated completion is 2032-03.

What conditions does trial NCT06414590 study?

This clinical trial studies the following conditions: Locally Advanced Unresectable Uveal Melanoma.

What interventions are being tested in trial NCT06414590?

The interventions under investigation include: Tebentafusp-Tebn (DRUG).

Who is sponsoring clinical trial NCT06414590?

This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06414590 being conducted?

This trial has 2 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT06414590's enrollment target sits among peer trials

19 1894th of 2000 higher than 103 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT06414590, the US trial registry maintained by the National Library of Medicine. NCT06414590 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.