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

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.

Trial Details

NCT ID
NCT05727904
Phase
PHASE3
Sponsor
Iovance Biotherapeutics, Inc.
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Lifileucel plus Pembrolizumab
  • Pembrolizumab with Optional Crossover Period
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Duarte, California, United States|34.13945,-117.97729
  • Los Angeles, California, United States|34.05223,-118.24368
  • San Francisco, California, United States|37.77493,-122.41942
  • Aurora, Colorado, United States|39.72943,-104.83192

Key Eligibility Criteria

  • Participant has a histologically or pathologically confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma.
  • In the investigator's assessment, the participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated li…
  • Participant is assessed as having at least one resectable lesion (or aggregate lesions) for lifileucel generation.
  • Participant must have at least one measurable disease as defined by RECIST 1.1 following tumor resection.

For full eligibility, visit ClinicalTrials.gov.

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