Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.
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
Who can join
Ages 18 to 70 · All sexes
Full eligibility 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.
About the study
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.
What is being tested
- Lifileucel plus Pembrolizumab (biological)
- Pembrolizumab with Optional Crossover Period (biological)
Sponsor: Iovance Biotherapeutics, Inc. · Participants: 670 · Started: Mar 30, 2023
Contact the study team
- Iovance Biotherapeutics https://www.tilvance-301.com · Phone: 1-844-845-4682
- Iovance Biotherapeutics Study Team · Phone: 1-844-845-4682
Official record on ClinicalTrials.gov — NCT05727904
Locations in the U.S.
| Alabama | University of Alabama at Birmingham: The Kirklin Clinic, Birmingham |
| California | City of Hope, Duarte USC Norris Comprehensive Cancer Center, Los Angeles |
| Colorado | University of Colorado Cancer Center, Aurora |
| Florida | Orlando Health Cancer Institute, Orlando |
| Maryland | National Cancer Institute, Bethesda |
| Minnesota | University of Minnesota, Minneapolis |
| New Hampshire | Dartmouth-Hitchcock Medical Center (DHMC) - Norris Cotton Cancer Center, Lebanon |
| New Jersey | MD Anderson Cancer Center at Cooper, Camden |
| Ohio | Oncology Hematology Care, Cincinnati Ohio State University, Columbus |
| Pennsylvania | Allegheny Health Network, Pittsburgh |
| Tennessee | Baptist Cancer Center, Bartlett SCRI Oncology Partners, Nashville |
| Utah | Intermountain Health, Salt Lake City |
| Washington | Swedish Cancer Institute, Edmonds |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.