Active (not recruiting) Phase 3 2022-503140-41-00

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

Phase 3 – large-scale trial before approval

Conditions: Melanoma

Sponsor: Iovance Biotherapeutics Inc.

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Overview

Trial status: Authorised OS is defined as the time from the date of randomization to death due to any cause 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

Description

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

Who can participate

Age group: 65+ years, 18-64 years Gender: Female, Male Target enrollment: 290 participants

Interventions

KEYTRUDA 25 mg/mL concentrate for solution for infusion

Drug

FLUDARABINE

Drug

Endoxan 1000 mg milteliai injekciniam tirpalui

Drug

KEYTRUDA 25 mg/mL concentrate for solution for infusion

Drug

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

Drug

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

Drug

Lifileucel

Drug

Fludarabine - PCH 25 mg/ml, concentraat voor oplossing voor intraveneuze infusie of injectie

Drug

KEYTRUDA 25 mg/mL concentrate for solution for infusion

Drug

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

Drug

KEYTRUDA 25 mg/mL concentrate for solution for infusion

Drug

Cyclophosphamide Injection 1 g

Drug

Endoxan

Drug

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

Drug

KEYTRUDA 25 mg/mL concentrate for solution for infusion

Drug

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

Drug

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

Drug

Cyclophosphamide 1000 mg Powder for Solution for Injection or Infusion

Drug

KEYTRUDA 25 mg/mL concentrate for solution for infusion

Drug

Fludarabine Accord 25 mg/ml koncentratas injekciniam ar infuziniam tirpalui

Drug

KEYTRUDA 25 mg/mL concentrate for solution for infusion

Drug

KEYTRUDA 25 mg/mL concentrate for solution for infusion

Drug

MESNA

Drug

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

Drug

MESNA

Drug

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

Drug

Locations 12

Belgium (1)

Czech Republic (1)

Finland (1)

France (1)

Germany (1)

Greece (1)

Italy (1)

Netherlands (1)

Poland (1)

Slovenia (1)

Spain (1)

Sweden (1)

Status

Active (not recruiting)

Phase

Phase 3

Study type

INTERVENTIONAL

Sex

Male and female

Minimum age

18 Years

Healthy volunteers

Start date

13.12.2023

Registry ID

2022-503140-41-00

Source

euclinicaltrials.eu

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