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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 81 to 82 Eligibility criteria expanded, about 16 words · Study description revised Show 2 more changesShow less
    • Eligibility criteria expanded, about 16 words
    • Study description revised
  2. Trial sites expanded: 75 → 81 locationsv49
  3. Study sites: 72 to 75v48
  4. Study sites: 71 to 72v47
  5. Study sites: 72 to 71v46
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  1. Study sites: 71 to 72v45
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  17. Re-verified, no change to tracked fieldsv29
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  32. Re-verified, no change to tracked fieldsv14
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  43. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Mar 1, 2023 to Mar 30, 2023v3 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 1, 2023 to Mar 30, 2023
  44. Study title shortened, about 16 wordsv2 See this version in full on ClinicalTrials.gov ↗
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Iovance Biotherapeutics
12 trials monitored
See 1 trial at risk
Melanoma
1,026 trials monitored
See 48 trials at risk
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 Number NCT05727904
Lead Sponsor Iovance Biotherapeutics, Inc.
Conditions Metastatic Melanoma, Unresectable Melanoma, Melanoma
Enrollment 670 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov