NCT05050006TerminatedPhase 2
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)
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Instil Bio
- Enrollment
- 29
- Locations
- 44
- Primary Endpoint
- Objective response rate
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Overall Survival(Up to 60 months)
- 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)
- Progression-free Survival(Up to 60 months)
- Duration of Response(Up to 60 months)
- Best Overall Response(Up to 60 months)
- Disease Control Rate(Up to 60 months)
- Time to Response(Up to 60 months)
Investigators
Study Sites (44)
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