A Phase 3 Study of LN-144 in Patients with Metastatic Melanoma

• Research type

  Research Study

• Full title

  A Phase 3, multicentre, randomized, open-label, parallel group, treatment study to assess the efficacy and safety of the lifileucel (LN-144, autologous tumour-infiltrating lymphocytes [TIL]) regimen in combination with pembrolizumab compared with pembrolizumab monotherapy in participants with untreated, unresectable or metastatic melanoma

• IRAS ID

  1007866

• Contact name

  Ran Xu

• Contact email

  info@iovance.com

• Sponsor organisation

  Iovance Biotherapeutics, Inc.

• Eudract number

  2022-503140-41

• Research summary

  The main purpose of this study is to see if lifileucel plus pembrolizumab works better than pembrolizumab alone to make the size of a patient’s tumour smaller and maybe make the tumor go away completely. The study doctor will also look at how long a patient will live before the tumour grows, and how long they will live after treatment. The other purpose of this study is to see how safe the study drugs are.

  Lifileucel is a new type of immunotherapy that uses the body’s immune system to kill cancer cells. Lifileucel is also called “tumour infiltrating lymphocytes” (TIL). It is made of a type of white blood cells called lymphocytes or T cells that are taken from a piece of the patient’s own tumour and grown into millions of cells in a laboratory. These T cells are good at finding and attacking the patient’s tumour.
  Pembrolizumab is a marketed immunotherapy medicine that works by connecting to a specific protein on T cells. This allows the T cells to find the hidden cancer cells and kill them. Researchers believe that lifileucel combined with pembrolizumab may help treat advanced melanoma that has not been treated before.

  About 670 patients will take part in this study at about 100 clinics worldwide. All patients will be assigned to 1 of the 2 treatment arms, Arm A or Arm B. All patients will have a 50-50 chance of being in either of the treatment arms. This study will consist of the following:
  - Screening Period
  - Enrolment (also known as randomization)
  - Treatment and Assessment Period
  - Follow-Up Period

  The study will last about 7 years. The length of the study for each patient will vary. The patients in the study will visit the clinic about 30 times in the first year. Only the patients in Arm A will have surgery to remove a piece of a tumour that will be used to make lifileucel. Patients in Arm B may have the option to get the lifileucel regimen if the melanoma gets worse or comes back while they are taking pembrolizumab (optional Arm B crossover).

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  23/SC/0249

• Date of REC Opinion

  13 Oct 2023

• REC opinion

  Further Information Favourable Opinion