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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (6 UK sites)
Queen Elizabeth Hospital Birmingham
Birmingham B15 2GW, United Kingdom
Freeman Hospital
Newcastle upon Tyne NE7 7DN, United Kingdom
Royal Marsden Hospital
Chelsea SW3 6JJ, United Kingdom
Beaston West of Scotland Canter Centre
Glasgow G120YN, United Kingdom
Guy's Hospital
London SE1 9RT, United Kingdom
Sarah Cannon Research Institute UK
London W1G 6AD, United Kingdom
How to Get in Touch
Iovance Biotherapeutics https://www.tilvance-301.com
Sponsor contactCONTACT
Iovance Biotherapeutics Study Team
Sponsor contactCONTACT
