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Taking people in SpainPhase 3

Tests lifileucel with pembrolizumab in untreated advanced melanoma

Tests lifileucel plus pembrolizumab against pembrolizumab alone in adults with advanced melanoma.

Key facts

Who runs it
Iovance Biotherapeutics, Inc.
Where
Barcelona, L'Hospitalet de Llobregat, Madrid, Málaga, Pamplona, Pozuelo de Alarcón, Santander, Sevilla, and Valencia, SpainSee the 14 sitesAlso in 19 other countries, 73 sites
Registry title
Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.
Status
Recruiting
Phase
Phase 3
People taking part
670 people, planned
Started
30 Mar 2023
Expected to end
1 Mar 2030
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Lifileucel plus Pembrolizumab
  • Pembrolizumab with Optional Crossover Period
Record updated
24 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with melanoma that cannot be removed by surgery or has spread, and who have not yet been treated for it.

Age
18 to 70 years. People over 70 may be allowed after the investigator talks with the medical monitor.
Sex
All sexes can join.
Disease stage
Stage IIIC, IIID or IV melanoma that cannot be removed by surgery or has spread. At least one lesion must be removable for making lifileucel. At least one measurable lesion is needed after tumor removal.
Earlier treatment
No earlier treatment for spread disease. No more than 1 prior line of therapy.

Main reasons for not taking part

  • Melanoma that started in the eye (uveal or ocular)
  • Brain metastases with symptoms that have not been treated
  • Any inherited or acquired immune system failure (for example SCID or AIDS)
  • Earlier allogeneic cell or organ transplant
  • Another primary cancer in the past 3 years (with some exceptions)

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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 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 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 a history of allogeneic cell or organ transplant; Other protocol defined inclusion/exclusion criteria could apply
  • Participant has melanoma of uveal/ocular origin
  • Participant has symptomatic untreated brain metastases
  • Participant has any form of primary or acquired immunodeficiency (eg, SCID or AIDS)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 70 years old?

Where in Spain

Also in 19 other countries, 73 sites

  • Hospital Clinic de BarcelonaBarcelona, SpainTaking people
  • Hospital Universitari Dexeus Grupo QuironsaludBarcelona, SpainTaking people
  • Institut Catala D'oncologiaL'Hospitalet de Llobregat, SpainTaking people
  • Clinica Universidad de NavarraMadrid, SpainTaking people
  • Hospital General Universitario Gregorio MarañónMadrid, SpainTaking people
  • Hospital Universitario 12 de OctubreMadrid, SpainTaking people
  • Hospital Universitario HM SanchinarroMadrid, SpainTaking people
  • Hospital Universitario Ramón y CajalMadrid, SpainTaking people
  • Hospital Universitario Regional de MálagaMálaga, SpainTaking people
  • Clínica Universidad de navarraPamplona, SpainTaking people
  • Hospital Universitario Quironsalud MadridPozuelo de Alarcón, SpainTaking people
  • Hospital Universitario Marqués de ValdecillaSantander, SpainTaking people
  • Hospital Universitario Virgen De La MacarenaSevilla, SpainTaking people
  • Hospital General Universitario de ValenciaValencia, SpainTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Arm ATreatment being tested

    Lifileucel plus Pembrolizumab

    Treatment: Lifileucel plus Pembrolizumab

  • Arm BExisting treatment, for comparison

    Pembrolizumab alone with Optional Crossover Period

    Treatment: Pembrolizumab with Optional Crossover Period

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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
Plain-language title
Tests lifileucel with pembrolizumab in untreated advanced melanomaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT05727904, who can take part
Record updated
24 September 2026