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Clinical Trial 21179

Cancer Type: Cutaneous
Study Type: Treatment
NCT#: NCT05050006

Phase: Phase II
Principal Investigator: Sarnaik, Amod

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Study Title

A Phase 2, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Autologous Tumor-infiltrating Lymphocytes (TILs) in Subjects with Advanced Melanoma


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 tumor-infiltrating immune cells (lymphocytes; TILs).


Primary Objectives: The primary objective is to evaluate the efficacy of ITIL-168 in advanced cutaneous melanoma. Secondary and Exploratory Objective(s): The secondary and exploratory objectives will further evaluate the safety and efficacy of ITIL-168, in addition to biomarker and health-related quality-of-life parameters.



Chemotherapy (NOS); Immunotherapy; Therapy (NOS)


IL-2 (Interleukin-2); ITIL-168 (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

Inclusion Criteria

  • Histologically confirmed advanced (unresectable or metastatic) cutaneous melanoma.
  • Cohort 1: Disease that is relapsed after or refractory to at least 1 prior line of systemic therapy that must include a PD-1 inhibitor and, if positive for proto- oncogene BRAF V600 activating mutation, targeted therapy.
  • Cohort 2: Disease that is persistent after discontinuing PD-1 due to toxicity. Patients with a proto-oncogene BRAF V600 activating mutation must have progressed after targeted therapy.
  • Cohort 3: Disease that is stable (SD) after at least 4 doses of a PD-1 inhibitor. Patients with a proto-oncogene BRAF V600 activating mutation must have progressed after targeted therapy.
  • Medically suitable for surgical resection of tumor tissue
  • Following tumor resection for TIL harvest, will have, at minimum, 1 remaining measurable lesion as identified by CT or MRI per > Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate bone marrow and organ function

  • Exclusion Criteria

  • History of another primary malignancy within the previous 3 years
  • Melanoma of uveal, acral, or mucosal origin
  • Previously received an allogeneic stem cell transplant or organ allograft
  • Previously received TIL or engineered cell therapy ( eg, CAR T-cell)
  • Significant cardiac disease
  • Stroke or transient ischemic attack within 12 months of enrollment
  • History of significant central nervous system (CNS) disorder
  • Symptomatic and/or untreated CNS metastases
  • History of significant autoimmune disease within 2 years prior to enrollment
  • Known history of severe, immediate hypersensitivity reaction attributed to cyclophosphamide, fludarabine, or IL-2.

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