We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

ITIL-168 in Advanced Melanoma (DELTA-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05050006
Recruitment Status : Active, not recruiting
First Posted : September 20, 2021
Last Update Posted : November 3, 2022
Sponsor:
Information provided by (Responsible Party):
Instil Bio

Tracking Information
First Submitted Date  ICMJE September 9, 2021
First Posted Date  ICMJE September 20, 2021
Last Update Posted Date November 3, 2022
Actual Study Start Date  ICMJE October 7, 2021
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2021)
Objective response rate [ Time Frame: Up to 60 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2021)
  • Duration of Response [ Time Frame: Up to 60 months ]
    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 [ Time Frame: Up to 60 months ]
    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 [ Time Frame: Up to 60 months ]
    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 [ Time Frame: Up to 60 months ]
    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 [ Time Frame: Up to 60 months ]
  • Disease Control Rate [ Time Frame: Up to 60 months ]
    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 Frame: Up to 60 months ]
  • Time to Response [ Time Frame: Up to 60 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ITIL-168 in Advanced Melanoma
Official Title  ICMJE 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)
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
All enrolled participants are assigned to be treated with a single dose of ITIL-168
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Cutaneous Melanoma
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Cohort 1
    Patients who relapsed after or were refractory to at least 1 prior line of systemic therapy including a PD-1 inhibitor.
    Intervention: Biological: ITIL-168
  • Experimental: Cohort 2
    Patients who were intolerant to a PD-1 inhibitor and have persistent disease after stopping PD-1 therapy.
    Intervention: Biological: ITIL-168
  • Experimental: Cohort 3
    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: Biological: ITIL-168
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 9, 2021)
130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2028
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05050006
Other Study ID Numbers  ICMJE ITIL-168-101
2020-003862-37 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Instil Bio
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Instil Bio
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Instil Study Director Instil Bio, Inc.
PRS Account Instil Bio
Verification Date November 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP