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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 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.

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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.

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

Sponsor

Richard Wu

1 total trials

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What the Registry Record Tells You About NCT05176470

The ClinicalTrials.gov registry entry for NCT05176470 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 47-participant average among 13 other Stage IV Melanoma trials with a reported enrollment target (96% lower). The listed sponsor is Richard Wu, which has 1 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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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.