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Recruiting Phase 3 Interventional

Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.

ClinicalTrials.gov ID: NCT05727904

Public ClinicalTrials.gov record NCT05727904. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 2, 2026, 6:56 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Multicenter, Randomized, Open-label, Parallel Group, Treatment Study to Assess the Efficacy and Safety of the Lifileucel (LN-144, Autologous Tumor Infiltrating Lymphocytes [TIL]) Regimen in Combination With Pembrolizumab Compared With Pembrolizumab Monotherapy in Participants With Untreated, Unresectable or Metastatic Melanoma

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a Phase 3, multicenter, open-label, randomized, parallel group, treatment study to assess the efficacy and safety of lifileucel in combination with pembrolizumab compared with pembrolizumab alone in participants with untreated, unresectable or metastatic melanoma. Participants randomized to the pembrolizumab monotherapy arm who subsequently have a blinded independent central review- verified confirmed progressive disease (PD) will be offered lifileucel monotherapy in an optional crossover period.

Study identification

NCT ID
NCT05727904
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Iovance Biotherapeutics, Inc.
Industry
Enrollment
670 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 70 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 29, 2023
Primary completion
Feb 29, 2028
Completion
Feb 28, 2030
Last update posted
Jun 25, 2026

2023 – 2030

United States locations

U.S. sites
24
U.S. states
18
U.S. cities
23
Facility City State ZIP Site status
University of Alabama at Birmingham: The Kirklin Clinic Birmingham Alabama 35233 Recruiting
City of Hope Duarte California 91010 Recruiting
USC Norris Comprehensive Cancer Center Los Angeles California 90007 Recruiting
California Pacific Medical Center San Francisco California 94107 Recruiting
University of Colorado Cancer Center Aurora Colorado 80045 Recruiting
Orlando Health Cancer Institute Orlando Florida 32806 Recruiting
University of Illinois Hospital & Health Sciences System Chicago Illinois 60612 Withdrawn
University of Kansas Kansas City Kansas 66205 Withdrawn
University of Louisville - James Graham Brown Cancer Center Louisville Kentucky 40202 Withdrawn
National Cancer Institute Bethesda Maryland 20814 Recruiting
Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center Detroit Michigan 48201 Withdrawn
Henry Ford Health Detroit Michigan 48202 Recruiting
University of Minnesota Minneapolis Minnesota 55455 Recruiting
Dartmouth-Hitchcock Medical Center (DHMC) - Norris Cotton Cancer Center Lebanon New Hampshire 03756 Recruiting
MD Anderson Cancer Center at Cooper Camden New Jersey 08103 Recruiting
Oncology Hematology Care Cincinnati Ohio 45226 Recruiting
Ohio State University Columbus Ohio 43201 Recruiting
St. Luke's Cancer Center - Anderson Easton Pennsylvania 18045 Withdrawn
Allegheny Health Network Pittsburgh Pennsylvania 15224 Recruiting
Baptist Cancer Center Bartlett Tennessee 37920 Recruiting
SCRI Oncology Partners Nashville Tennessee 37203 Recruiting
Intermountain Health Salt Lake City Utah 84112 Recruiting
Virginia Commonwealth University Richmond Virginia 23298 Withdrawn
Swedish Cancer Institute Edmonds Washington 98026 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 57 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05727904, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 25, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05727904 live on ClinicalTrials.gov.

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