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Combining lifileucel with pembrolizumab for advanced melanoma treatment

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

Phase 3 Interventional Iovance Biotherapeutics, Inc. · NCT05727904

This study is testing if combining a new treatment called lifileucel with pembrolizumab can help people with advanced melanoma feel better compared to just using pembrolizumab alone.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment670 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorIovance Biotherapeutics, Inc. Industry-sponsored
Drugs / interventionspembrolizumab
Locations75 sites (Birmingham, Alabama and 74 other locations)
Trial IDNCT05727904 on ClinicalTrials.gov

What this trial studies

This Phase 3, multicenter, open-label trial investigates the effectiveness and safety of lifileucel in combination with pembrolizumab compared to pembrolizumab alone in patients with untreated, unresectable or metastatic melanoma. Participants will be randomly assigned to receive either the combination therapy or pembrolizumab alone, with an option for crossover to lifileucel if their disease progresses. The study aims to enroll individuals with specific stages of melanoma who have not received prior treatment for metastatic disease, ensuring a focused evaluation of the new treatment regimen.

Who should consider this trial

Good fit: Ideal candidates are individuals with Stage IIIC, IIID, or IV unresectable or metastatic melanoma who have not received prior therapy for metastatic disease.

Not a fit: Patients with melanoma of uveal/ocular origin or those who have received prior treatment for metastatic disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective option for patients with advanced melanoma, potentially improving survival rates.

How similar studies have performed: Other studies have shown promising results with similar combination therapies in melanoma, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Participant has a histologically or pathologically confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma.
2. 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.
3. Participant is assessed as having at least one resectable lesion (or aggregate lesions) for lifileucel generation.
4. Participant must have at least one measurable disease as defined by RECIST 1.1 following tumor resection.
5. Participants must have adequate organ function.
6. Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control.
7. Participants who are \> 70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.

Exclusion Criteria:

1. Participant has melanoma of uveal/ocular origin.
2. Participant has symptomatic untreated brain metastases.
3. Participant received more than 1 prior line of therapy.
4. Participant received prior therapy for metastatic disease
5. Participants with a BRAF V600 mutation-positive tumor received prior adjuvant/neoadjuvant ICI therapy only
6. 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.
7. Participant has any form of primary or acquired immunodeficiency (eg, SCID or AIDS).
8. 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.)
9. Participant has a history of allogeneic cell or organ transplant.

Other protocol defined inclusion/exclusion criteria could apply.

Where this trial is running

Birmingham, Alabama and 74 other locations

+25 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic MelanomaUnresectable MelanomaMelanomaTumor Infiltrating LymphocytesTILCell TherapyCellular Immuno-therapyIL-2
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.