NCT05727904Recruiting
Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.
Summary
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.
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.
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Italy, United States, Australia, Belgium, Canada, Finland, Israel, Netherlands, Singapore, South Korea, Spain, Sweden, United Kingdom
- Sponsor
- Iovance Biotherapeutics, Inc.(Industry)
- Protocol no.
- IOV-MEL-301
- Conditions
- Metastatic Melanoma, Unresectable Melanoma, Melanoma
- Interventions
- Biological
Treatments studied
- Lifileucel plus Pembrolizumab
- Pembrolizumab with Optional Crossover Period
Locations · 71
- Lausanne, SwitzerlandCentre Hospitalier Universitaire Vaudois LausanneRecruiting at this site
- Marseille, FranceInstitut Paoli CalmettesRecruiting at this site
- Nantes, FranceCentre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-DieuRecruiting at this site
- Paris, FranceHopital Saint LouisRecruiting at this site
- Berlin, GermanyCharité - Universitätsmedizin BerlinRecruiting at this site
- Würzburg, GermanyUniversitätsklinikum WürzburgRecruiting at this site
- Dresden, GermanyUniversitätsklinikum Carl Gustav CarusRecruiting at this site
- Hamburg, GermanyUniversitätsklinikum Hamburg-EppendorfRecruiting at this site
- Lübeck, GermanyUniversitätsklinikum Schleswig-Holstein - Campus LübeckRecruiting at this site
- Munich, GermanyKlinikum Rechts der Isar der Technischen Universität MünchenRecruiting at this site
- Meldola, ItalyIstituto Romagnolo per lo Studio dei TumoriRecruiting at this site
- Aviano, ItalyCentro di Riferimento Oncologico IRCCSRecruiting at this site
- Naples, ItalyIstituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni PascaleRecruiting at this site
- Pisa, ItalyAzienda Ospedaliero Universitaria PisanaRecruiting at this site
- Siena, ItalyAzienda Ospedaliera Universitaria SeneseRecruiting at this site
- Birmingham, United StatesUniversity of Alabama at Birmingham: The Kirklin ClinicRecruiting at this site
- Duarte, United StatesCity of HopeRecruiting at this site
- Los Angeles, United StatesUSC Norris Comprehensive Cancer CenterRecruiting at this site
- Aurora, United StatesUniversity of Colorado Cancer CenterRecruiting at this site
- Orlando, United StatesOrlando Health Cancer InstituteRecruiting at this site
- Bethesda, United StatesNational Cancer InstituteRecruiting at this site
- Minneapolis, United StatesUniversity of MinnesotaRecruiting at this site
- Lebanon, United StatesDartmouth-Hitchcock Medical Center (DHMC) - Norris Cotton Cancer CenterRecruiting at this site
- Camden, United StatesMD Anderson Cancer Center at CooperRecruiting at this site
- Cincinnati, United StatesOncology Hematology CareRecruiting at this site
- Columbus, United StatesOhio State UniversityRecruiting at this site
- Pittsburgh, United StatesAllegheny Health NetworkRecruiting at this site
- Bartlett, United StatesBaptist Cancer CenterRecruiting at this site
- Nashville, United StatesSCRI Oncology PartnersRecruiting at this site
- Salt Lake City, United StatesIntermountain HealthRecruiting at this site
In total, worldwide, 71 of the 82 sites listed in the registry are recruiting; the other 11 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: September 24, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 41 more locations
Other identifiers
- TILVANCE-301 · other identifier
- TILVANCE · other identifier
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.