Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma. (NCT05727904)
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-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham: The Kirklin Clinic — Birmingham, Alabama
Age range: 18 Years to 70 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (81 Sites)
Showing the first 25 of 81 sites.
- University of Alabama at Birmingham: The Kirklin Clinic — Birmingham, Alabama
- City of Hope — Duarte, California
- USC Norris Comprehensive Cancer Center — Los Angeles, California
- California Pacific Medical Center — San Francisco, California
- University of Colorado Cancer Center — Aurora, Colorado
- Orlando Health Cancer Institute — Orlando, Florida
- University of Illinois Hospital & Health Sciences System — Chicago, Illinois
- University of Kansas — Kansas City, Kansas
- University of Louisville - James Graham Brown Cancer Center — Louisville, Kentucky
- National Cancer Institute — Bethesda, Maryland
- Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center — Detroit, Michigan
- Henry Ford Health — Detroit, Michigan
- University of Minnesota — Minneapolis, Minnesota
- Dartmouth-Hitchcock Medical Center (DHMC) - Norris Cotton Cancer Center — Lebanon, New Hampshire
- MD Anderson Cancer Center at Cooper — Camden, New Jersey
- Oncology Hematology Care — Cincinnati, Ohio
- Ohio State University — Columbus, Ohio
- St. Luke's Cancer Center - Anderson — Easton, Pennsylvania
- Allegheny Health Network — Pittsburgh, Pennsylvania
- Baptist Cancer Center — Bartlett, Tennessee
- SCRI Oncology Partners — Nashville, Tennessee
- Intermountain Health — Salt Lake City, Utah
- Virginia Commonwealth University — Richmond, Virginia
- Swedish Cancer Institute — Edmonds, Washington
- Greenslopes Private Hospital — Greenslopes, Queensland
📞 Contact the Study Coordinator
Phone: (844) 845-4682
Email: Clinical.Inquiries@iovance.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Metastatic Melanoma
- Abbreviated MAPK Targeted Therapy Plus Pembrolizumab in Melanoma — Boston, Massachusetts
- IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18) — Orange City, Florida
- Cediranib Maleate and Selumetinib Sulfate in Treating Patients With Solid Malignancies — Jacksonville, Florida
- Genetically Modified T-Cells Followed by Aldesleukin in Treating Patients With Stage III-IV Melanoma — Houston, Texas
- Adjuvant, Combined Interleukin 2 (Proleukin) and DTIC (Dacarbazine) in High-risk Melanoma Patients — Louisville, Kentucky
- Comparison of High-dose IL-2 and High-dose IL-2 With Radiation Therapy in Patients With Metastatic Melanoma. — Portland, Oregon
Explore by condition: All Metastatic Melanoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.