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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-503140-41-00

Acronym

IOV-MEL-301

Enrollment

280

Registered

2023-12-13

Start date

2024-11-29

Completion date

Unknown

Last updated

2025-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Brief summary

PFS is defined as the time from the date of randomization until disease progression assessed by the BIRC per RECIST v1.1 or death due to any cause

Detailed description

OS is defined as the time from the date of randomization to death due to any cause

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGEndoxan 1000 mg milteliai injekciniam tirpalui

DRUGLifileucel

DRUGProleukin 18 x 106 IE Poeder voor oplossing voor injectie of infusie

DRUGEndoxan

DRUGFludarabine Accord 25 mg/ml koncentratas injekciniam ar infuziniam tirpalui

DRUGPROLEUKIN® 18 x 106 IU Powder for solution for injection or infusion

DRUGCyclophosphamide 1000 mg Powder for Solution for Injection or Infusion

DRUGFludarabine Teva 25 mg/ml concentraat voor oplossing voor injectie of infusie

DRUGFludarabine Phosphate 25 mg/ml Concentrate for Solution for Injection or Infusion

DRUGCyclophosphamide Injection 1 g

DRUGFludarabine Teva 25 mg/ml solution à diluer pour injection ou perfusion

DRUGMESNA

DRUGFludarabine phosphate 25 mg/ml Concentrate for Solution for Injection or Infusion

DRUGFludarabine - PCH 25 mg/ml

DRUGconcentraat voor oplossing voor intraveneuze infusie of injectie

DRUGФлударабин Актавис 25 mg/ml концентрат за инжекционен или инфузионен разтвор

DRUGFLUDARABINE

DRUGFludarabina Teva 25 mg/ml concentrado para solución para perfusión o inyección EFG

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
PFS is defined as the time from the date of randomization until disease progression assessed by the BIRC per RECIST v1.1 or death due to any cause	—

Secondary

Measure	Time frame
OS is defined as the time from the date of randomization to death due to any cause	—

Countries

Belgium, Czechia, Finland, France, Germany, Greece, Italy, Netherlands, Poland, Slovenia, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026