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

Recruiting now · Phase 3

Conditions studied: Metastatic Melanoma, Unresectable Melanoma, Melanoma

In brief

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.

Key facts

Study ID

NCT05727904

Run by

Iovance Biotherapeutics, Inc.

People needed

670

Starts

2023-03-30

Expected to finish

2030-03-01

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant has a histologically or pathologically confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma.
• In the investigator's assessment, the participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of > 6 months.
• Participant is assessed as having at least one resectable lesion (or aggregate lesions) for lifileucel generation.
• Participant must have at least one measurable disease as defined by RECIST 1.1 following tumor resection.
• Participants must have adequate organ function.
• Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control.
• Participants who are > 70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.

You may not qualify if…

• Participant has melanoma of uveal/ocular origin.
• Participant has symptomatic untreated brain metastases.
• Participant received more than 1 prior line of therapy.
• Participant received prior therapy for metastatic disease
• Participants with a BRAF V600 mutation-positive tumor received prior adjuvant/neoadjuvant ICI therapy only
• Participant has an active medical illness(es) that, in the opinion of the investigator, would pose increased risks for study participation, such as systemic infections; seizure disorders; coagulation disorders; or other active major medical illnesses of the cardiovascular, respiratory, or immune systems.
• Participant has any form of primary or acquired immunodeficiency (eg, SCID or AIDS).
• Participant had another primary malignancy within the previous 3 years (except for those that do not require treatment or were curatively treated >1 year ago, and in the judgment of the investigator do not pose a significant risk of recurrence.)
• Participant has a history of allogeneic cell or organ transplant.
• Other protocol defined inclusion/exclusion criteria could apply.

Where it is running

• Universitair Ziekenhuis Brussel - Oncologisch Centrum — Jette, Belgium (enrolling)
• University of Alabama at Birmingham: The Kirklin Clinic — Birmingham, Alabama, United States (enrolling)
• Fiona Stanley Hospital — Murdoch, Western Australia, Australia (enrolling)
• Westmead Hospital — Westmead, Australia (enrolling)
• Orlando Health Cancer Institute — Orlando, Florida, United States (enrolling)
• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
• California Pacific Medical Center — San Francisco, California, United States (enrolling)
• Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (enrolling)
• National Cancer Institute — Bethesda, Maryland, United States (enrolling)
• Flinders Medical Centre — Bedford Park, Australia (enrolling)
• Henry Ford Health — Detroit, Michigan, United States (enrolling)
• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• Dartmouth-Hitchcock Medical Center (DHMC) - Norris Cotton Cancer Center — Lebanon, New Hampshire, United States (enrolling)
• MD Anderson Cancer Center at Cooper — Camden, New Jersey, United States (enrolling)
• Oncology Hematology Care — Cincinnati, Ohio, United States (enrolling)
• Ohio State University — Columbus, Ohio, United States (enrolling)
• City of Hope — Duarte, California, United States (enrolling)
• Allegheny Health Network — Pittsburgh, Pennsylvania, United States (enrolling)
• Baptist Cancer Center — Bartlett, Tennessee, United States (enrolling)
• SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
• Intermountain Health — Salt Lake City, Utah, United States (enrolling)
• University of Colorado Cancer Center — Aurora, Colorado, United States (enrolling)
• Swedish Cancer Institute — Edmonds, Washington, United States (enrolling)
• Greenslopes Private Hospital — Greenslopes, Queensland, Australia (enrolling)
• Centre hospitalier de l'Université de Montréal — Montreal, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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