ITIL-168 in Advanced Melanoma

Official Title

A Phase 2, Open-label, Multicentre Study Evaluating the Safety and Efficacy of Autologous Tumour-infiltrating Lymphocytes (TILs) in Subjects With Advanced Melanoma (DELTA-1)


DELTA-1 is a phase 2 clinical trial to evaluate the efficacy and safety of ITIL-168 in adult subjects with advanced melanoma who have previously been treated with a PD-1 inhibitor. ITIL-168 is a cell therapy derived from a patient's own tumour-infiltrating immune cells (lymphocytes; TILs).

Trial Description

Primary Outcome:

  • Objective response rate
Secondary Outcome:
  • Duration of Response
  • Progression-free Survival
  • Overall Survival
  • ORR as determined by investigators
  • Frequency, duration, and severity of ITIL-168 treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest
  • Disease Control Rate
  • Best Overall Response
  • Time to Response

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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society