Back to resultsITIL-168 in Advanced Melanoma (DELTA-1)
Primary Purpose
Advanced Cutaneous Melanoma
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ITIL-168
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Cutaneous Melanoma focused on measuring ITIL-168, Cell Therapy, melanoma, Autologous cell therapy, Cellular Immunotherapy, TIL, Autologous Adoptive Cell Transfer, Immuno-oncology, IL-2, Autologous Adoptive Cell Therapy, Tumor Infiltrating Lymphocytes, T-cell therapy
Eligibility Criteria
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.
Sites / Locations
- University of California San Diego, Moores Cancer Center
- The Angeles Clinic and Research Institute
- USC - Norris Comprehensive Cancer Center
- UCLA Health - Westwood Cancer Care
- Stanford Cancer Institute
- University of Colorado - Anschutz Cancer Pavilion
- Georgetown University Medical Center
- The University of Miami - Sylvester Comprehensive Cancer Center
- Orlando Health Cancer Institute
- Moffitt Cancer Center
- Rush University Cancer Center
- Loyola University Chicago
- University of Louisville, James Graham Brown Cancer Center
- Massachusetts General Hospital
- Beth Israel Deaconess Medical Center
- University of Minnesota, Masonic Cancer Center
- Atlantic Health System - Morristown Medical Center
- Cleveland Clinic - Taussig Cancer Center
- St. Luke's University Health Network
- Fox Chase Cancer Center
- Princess Margaret Cancer Centre
- Cambridge University Hospital NHS Foundation Trust - Addenbrooke's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Cohort 3
Arm Description
Patients who relapsed after or were refractory to at least 1 prior line of systemic therapy including a PD-1 inhibitor.
Patients who were intolerant to a PD-1 inhibitor and have persistent disease after stopping PD-1 therapy.
Patients who had a best response of stable disease despite being treated with at least 4 doses of a PD-1 inhibitor in the previous line of therapy.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Overall Survival
Overall survival (OS) is defined as the time from the ITIL-168 infusion date to the date of death from any cause.
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.
Frequency, duration, and severity of ITIL-168 treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest
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.
Best Overall Response
Time to Response
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05050006
Brief Title
ITIL-168 in Advanced Melanoma
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Business Decision
Study Start Date
October 7, 2021 (Actual)
Primary Completion Date
February 27, 2023 (Actual)
Study Completion Date
February 27, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instil Bio
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Cutaneous Melanoma
Keywords
ITIL-168, Cell Therapy, melanoma, Autologous cell therapy, Cellular Immunotherapy, TIL, Autologous Adoptive Cell Transfer, Immuno-oncology, IL-2, Autologous Adoptive Cell Therapy, Tumor Infiltrating Lymphocytes, T-cell therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
All enrolled participants are assigned to be treated with a single dose of ITIL-168
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Patients who relapsed after or were refractory to at least 1 prior line of systemic therapy including a PD-1 inhibitor.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Patients who were intolerant to a PD-1 inhibitor and have persistent disease after stopping PD-1 therapy.
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Patients who had a best response of stable disease despite being treated with at least 4 doses of a PD-1 inhibitor in the previous line of therapy.
Intervention Type
Biological
Intervention Name(s)
ITIL-168
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective response rate
Description
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.
Time Frame
Up to 60 months
Secondary Outcome Measure Information:
Title
Duration of Response
Description
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.
Time Frame
Up to 60 months
Title
Progression-free Survival
Description
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.
Time Frame
Up to 60 months
Title
Overall Survival
Description
Overall survival (OS) is defined as the time from the ITIL-168 infusion date to the date of death from any cause.
Time Frame
Up to 60 months
Title
ORR as determined by investigators
Description
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.
Time Frame
Up to 60 months
Title
Frequency, duration, and severity of ITIL-168 treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest
Time Frame
Up to 60 months
Title
Disease Control Rate
Description
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.
Time Frame
Up to 60 months
Title
Best Overall Response
Time Frame
Up to 60 months
Title
Time to Response
Time Frame
Up to 60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Instil Study Director
Organizational Affiliation
Instil Bio, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of California San Diego, Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
The Angeles Clinic and Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
USC - Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA Health - Westwood Cancer Care
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford Cancer Institute
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado - Anschutz Cancer Pavilion
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
The University of Miami - Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Orlando Health Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Rush University Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Loyola University Chicago
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
University of Louisville, James Graham Brown Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Minnesota, Masonic Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Atlantic Health System - Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Cleveland Clinic - Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
St. Luke's University Health Network
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Cambridge University Hospital NHS Foundation Trust - Addenbrooke's Hospital
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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ITIL-168 in Advanced Melanoma
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