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Looking for participantsPhase3

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

Sponsor: Iovance Biotherapeutics, Inc.

NCT ID: NCT05727904

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Lifileucel plus Pembrolizumab (biological), Pembrolizumab with Optional Crossover Period (biological)
How long the study runs
Study runs about 84 months (dates as stated)
About the drug or intervention
Lifileucel plus Pembrolizumab — biological: A tumor sample is resected from each patient for Lifileucel manufacturing. · Pembrolizumab with Optional Crossover Period — biological: Patient will receive Pembrolizumab monotherapy every 6 weeks until disease progression.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 70 Years
Who
All
Number of participants
670
Started
2023-03-30
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for metastatic melanoma
  • • Phase3 - 670 participants
  • • 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

Who can take part?

  • • Ages 18 Years to 70 Years
  • • Diagnosed with metastatic melanoma

Where?

  • • Birmingham - Queen Elizabeth Hospital Birmingham
  • • Newcastle upon Tyne - Freeman Hospital
  • • Chelsea - Royal Marsden Hospital
  • • Glasgow - Beaston West of Scotland Canter Centre
  • • +2 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

The study will enroll participants with unresectable or metastatic melanoma (Stage IIIC, IIID, or IV per the American Joint Committee on Cancer \[AJCC\] staging system) who have had no prior therapy for metastatic disease. Previous adjuvant/neoadjuvant therapy with a single line of protooncogene B-Raf (BRAF) inhibitor with or without a mitogen-activated protein kinase (MEK) inhibitor, PD-1 inhibitor, or cytotoxic T-lymphocyte-associated antigen-4 \[CTLA-4\] inhibitor is allowed, provided such treatment was completed ≥6 months before progression to metastatic disease.

Metastatic MelanomaUnresectable MelanomaMelanoma

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 70 Years
  • Who can join: All genders

Biomarkers mentioned

BRAF

Treatment history

Treatments you must have had:

  • ✓ at least one measurable disease as defined by RECIST 1
  • ✓ adequate organ function

What the study is looking for

  • ✓Participant has a histologically or pathologically confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or...
  • ✓In the investigator's assessment, the participant has an activity scale (ECOG) performance...
  • ✓Participant is assessed as having at least one resectable lesion (or aggregate lesions) for lifileucel generation.
  • ✓Participant must have at least one cancer that can be measured on scans as defined by (standard scan measurements) following tumor resection.
  • ✓Participants must have healthy organ.

Who cannot take part

  • ✗Participant has melanoma of uveal/ocular origin.
  • ✗Participant has causing symptoms untreated brain metastases.
  • ✗Participant received more than 1 previous treatments.
  • ✗Participant received prior therapy for that has spread disease
  • ✗Participants with a BRAF V600 mutation-positive tumor received prior after surgery/before surgery ICI therapy only
See the full 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 Is This Study? (6 UK sites)

Queen Elizabeth Hospital Birmingham

Birmingham B15 2GW, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

Freeman Hospital

Newcastle upon Tyne NE7 7DN, United Kingdom

Recruiting

Royal Marsden Hospital

Chelsea SW3 6JJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

Beaston West of Scotland Canter Centre

Glasgow G120YN, United Kingdom

Recruiting
Hospital R&D contact (matched)

Jennifer McLean

jennifer.mclean@health.scot.nhs.uk0131 537 4718

Guy's Hospital

London SE1 9RT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

Sarah Cannon Research Institute UK

London W1G 6AD, United Kingdom

Recruiting

How to Get in Touch

Iovance Biotherapeutics https://www.tilvance-301.com

Sponsor contact

CONTACT

1-844-845-4682 Clinical.Inquiries@iovance.com

Iovance Biotherapeutics Study Team

Sponsor contact

CONTACT

1-844-845-4682 Clinical.Inquiries@iovance.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09