ITIL-168 in Advanced Melanoma

Advanced Cutaneous Melanoma Clinical Trial

— DELTA-1  

Official 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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05050006
• Other study ID #: ITIL-168-101
• Secondary ID: 2020-003862-37
• Status: Terminated
• Phase: Phase 2
• Start date: October 7, 2021
• Est. completion date: February 27, 2023

Study information

• Verified date: April 2024
• Source: Instil Bio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: February 27, 2023
• Est. primary completion date: February 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key 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

Key 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.

Related Conditions & MeSH terms

• Advanced Cutaneous Melanoma
• Melanoma

Intervention

Biological:
• ITIL-168
ITIL-168 is a cell therapy product derived from a patient's own TILs. A tumor sample is removed from each patient to make a personalized ITIL-168 product. Once ITIL-168 has been made, the patient is treated with 5 days of lymphodepleting chemotherapy including cyclophosphamide and fludarabine, followed by a single infusion of ITIL-168, and up to 8 doses of IL-2.

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
United Kingdom	Cambridge University Hospital NHS Foundation Trust - Addenbrooke's Hospital	Cambridge	England
United States	University of Colorado - Anschutz Cancer Pavilion	Aurora	Colorado
United States	St. Luke's University Health Network	Bethlehem	Pennsylvania
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Rush University Cancer Center	Chicago	Illinois
United States	Cleveland Clinic - Taussig Cancer Center	Cleveland	Ohio
United States	University of California San Diego, Moores Cancer Center	La Jolla	California
United States	The Angeles Clinic and Research Institute	Los Angeles	California
United States	UCLA Health - Westwood Cancer Care	Los Angeles	California
United States	USC - Norris Comprehensive Cancer Center	Los Angeles	California
United States	University of Louisville, James Graham Brown Cancer Center	Louisville	Kentucky
United States	Loyola University Chicago	Maywood	Illinois
United States	The University of Miami - Sylvester Comprehensive Cancer Center	Miami	Florida
United States	University of Minnesota, Masonic Cancer Center	Minneapolis	Minnesota
United States	Atlantic Health System - Morristown Medical Center	Morristown	New Jersey
United States	Orlando Health Cancer Institute	Orlando	Florida
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Stanford Cancer Institute	Stanford	California
United States	Moffitt Cancer Center	Tampa	Florida
United States	Georgetown University Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Instil Bio

Countries where clinical trial is conducted

United States,  Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	Objective response rate (ORR), defined as the incidence of a complete response (CR) or a partial response (PR) per a modified Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria, as assessed by central review.	Up to 60 months
Secondary	Duration of Response	For subjects who experience an objective response, duration of response (DOR) is defined as the time from their first objective response to disease progression or death.	Up to 60 months
Secondary	Progression-free Survival	Progression-free survival (PFS) is defined as the time from the ITIL-168 infusion date to the date of disease progression or death from any cause.	Up to 60 months
Secondary	Overall Survival	Overall survival (OS) is defined as the time from the ITIL-168 infusion date to the date of death from any cause.	Up to 60 months
Secondary	ORR as determined by investigators	ORR as determined by investigators is defined as the incidence of a CR or a PR per a modified RECIST v1.1, as determined by study investigators.	Up to 60 months
Secondary	Frequency, duration, and severity of ITIL-168 treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest		Up to 60 months
Secondary	Disease Control Rate	Disease control rate (DCR), defined as the incidence of CR, PR, or stable disease (SD) per a modified RECIST v1.1 criteria, as determined by central review.	Up to 60 months
Secondary	Best Overall Response		Up to 60 months
Secondary	Time to Response		Up to 60 months