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NCT05176470 · ClinicalTrials.gov registry record · Phase 1

Neoadj Admin Autologous Tumor Infiltrating Lymphocytes & Pembrolizumab for Treatment of Adv Melanoma Patients

A Phase 1 study of Stage IV Melanoma and Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, sponsored by Richard Wu.

Active
Registry status
Phase 1
Development phase
2
Enrollment target
1
Study location

NCT05176470: Active Phase 1 study of Stage IV Melanoma and Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, sponsored by Richard Wu.

NCT05176470 is a Phase 1 study of Stage IV Melanoma and Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 that is active but no longer recruiting, run by Richard Wu. The registered enrollment target is 2 participants, below the 47-participant average among 13 other Stage IV Melanoma trials with a reported enrollment target (96% 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

NCT05176470, a Phase 1 study of Stage IV Melanoma and Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, is active but no longer recruiting, sponsored by Richard Wu.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
2 participants
Enrollment target
1
Study location

Study Summary

This phase I/II trial tests the safety and side effects of LN-144 (Lifileucel) and pembrolizumab in treating patients with stage IIIB-D or stage IV melanoma that has spread to nearby tissue or lymph nodes. Biological therapies, such as LN-144 (Lifileucel), use substances made from living organisms that may attack specific tumor cells and stop them from growing or kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lifileucel and pembrolizumab may make the tumor smaller.

Primary Outcome

Success rate of tumor infiltrating lymphocyte (TIL) expansion from all screened eligible patients who have had tumor-involved lymph node(s) removed; percentage of all eligible patients who have completed the screening and treated with LN-144/lifileucel.

Conditions Studied

Stage IV Melanoma Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 Locally Advanced Melanoma Pathologic Stage IIIB Cutaneous Melanoma AJCC v8 Pathologic Stage IIID Cutaneous Melanoma AJCC v8

Interventions

  • BIOLOGICAL Pembrolizumab
  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • BIOLOGICAL Lifileucel
  • PROCEDURE Therapeutic Conventional Surgery

Study Locations (1)

Ohio

  • Ohio State University Comprehensive Cancer Center - Columbus

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2022-07-01
Est. Completion 2026-12-31
Phase Phase 1
Richard Wu

1 total trials

What the registry record for NCT05176470 still lists

NCT05176470 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 47-participant average among 13 other Stage IV Melanoma trials with a reported enrollment target (96% lower).

The record links to 5 conditions, with Stage IV Melanoma appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.

NCT05176470 reports a single indexed study location in Ohio.

Frequently Asked Questions

What is clinical trial NCT05176470 about?

NCT05176470 is a clinical study titled "Neoadj Admin Autologous Tumor Infiltrating Lymphocytes & Pembrolizumab for Treatment of Adv Melanoma Patients". This phase I/II trial tests the safety and side effects of LN-144 (Lifileucel) and pembrolizumab in treating patients with stage IIIB-D or stage IV melanoma that has spread to nearby tissue or lymph nodes. Biological therapies, such as LN-144 (Lifileucel), use substances made from living organisms t...

What is the current status of trial NCT05176470?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2022-07-01. Estimated completion is 2026-12-31.

What conditions does trial NCT05176470 study?

This clinical trial studies the following conditions: Stage IV Melanoma, Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, Locally Advanced Melanoma, Pathologic Stage IIIB Cutaneous Melanoma AJCC v8, Pathologic Stage IIID Cutaneous Melanoma AJCC v8.

What interventions are being tested in trial NCT05176470?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Cyclophosphamide (DRUG), Fludarabine (DRUG), Lifileucel (BIOLOGICAL), Therapeutic Conventional Surgery (PROCEDURE).

Who is sponsoring clinical trial NCT05176470?

This trial is sponsored by Richard Wu, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05176470 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Stage IV 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 NCT05176470's enrollment target sits among peer trials

2 14th of 13 the lowest of 13 other Stage IV Melanoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Stage IV 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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Related registry views

Source: ClinicalTrials.gov NCT05176470, the US trial registry maintained by the National Library of Medicine. NCT05176470 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.