ITIL-168 in Advanced Melanoma
- Conditions
- Advanced Cutaneous Melanoma
- Registration Number
- NCT05050006
- Lead Sponsor
- Instil Bio
- 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 available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 29
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Objective response rate 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.
- Secondary Outcome Measures
Name Time Method Overall Survival 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.
Frequency, duration, and severity of ITIL-168 treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest Up to 60 months ORR as determined by investigators 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.
Progression-free Survival 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.
Duration of Response 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.
Best Overall Response Up to 60 months Disease Control Rate 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.
Time to Response Up to 60 months
Trial Locations
- Locations (22)
University of California San Diego, Moores Cancer Center
🇺🇸La Jolla, California, United States
The Angeles Clinic and Research Institute
🇺🇸Los Angeles, California, United States
USC - Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
UCLA Health - Westwood Cancer Care
🇺🇸Los Angeles, California, United States
Stanford Cancer Institute
🇺🇸Stanford, California, United States
University of Colorado - Anschutz Cancer Pavilion
🇺🇸Aurora, Colorado, United States
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
The University of Miami - Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
Orlando Health Cancer Institute
🇺🇸Orlando, Florida, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Scroll for more (12 remaining)University of California San Diego, Moores Cancer Center🇺🇸La Jolla, California, United States