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 May 8, 2026, 11:51 PM 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

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

Conditions

Interventions

Lifileucel plus Pembrolizumab Biological
Pembrolizumab with Optional Crossover Period Biological

Biological

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: Apr 2, 2026

2023 – 2030

United States locations

U.S. sites: 22
U.S. states: 16
U.S. cities: 21

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University of Illinois Hospital & Health Sciences System	Chicago	Illinois	60612	Withdrawn
University of Kansas	Kansas City	Kansas	66205	Withdrawn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
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
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 53 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 Apr 2, 2026 · Synced May 8, 2026

Open the official record

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

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