Melanoma Clinical Trial

ITIL-168 in Advanced Melanoma

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).

View Eligibility Criteria

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.

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

130

Study ID:

NCT05050006

Recruitment Status:

Active, not recruiting

Sponsor:

Instil Bio

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There are 22 Locations for this study

See Locations Near You

University of California San Diego, Moores Cancer Center
La Jolla California, 92093, United States
The Angeles Clinic and Research Institute
Los Angeles California, 90025, United States
USC - Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
UCLA Health - Westwood Cancer Care
Los Angeles California, 90095, United States
Stanford Cancer Institute
Stanford California, 94305, United States
University of Colorado - Anschutz Cancer Pavilion
Aurora Colorado, 80045, United States
Georgetown University Medical Center
Washington District of Columbia, 20007, United States
The University of Miami - Sylvester Comprehensive Cancer Center
Miami Florida, 33136, United States
Orlando Health Cancer Institute
Orlando Florida, 32806, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Rush University Cancer Center
Chicago Illinois, 60612, United States
Loyola University Chicago
Maywood Illinois, 60153, United States
University of Louisville, James Graham Brown Cancer Center
Louisville Kentucky, 40202, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
University of Minnesota, Masonic Cancer Center
Minneapolis Minnesota, 55455, United States
Atlantic Health System - Morristown Medical Center
Morristown New Jersey, 07962, United States
Cleveland Clinic - Taussig Cancer Center
Cleveland Ohio, 44195, United States
St. Luke's University Health Network
Bethlehem Pennsylvania, 18015, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
Cambridge University Hospital NHS Foundation Trust - Addenbrooke's Hospital
Cambridge England, CB2 0, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

130

Study ID:

NCT05050006

Recruitment Status:

Active, not recruiting

Sponsor:


Instil Bio

How clear is this clinincal trial information?

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