ITIL-168 in Advanced Melanoma (DELTA-1)
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)
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Clinical Trial Information
Trial Contact: Donaldson, Karin M; Grofsik, Kiera; Frankos, Marie
Trial Phone: 321.841.9821 ; 321.841.6626 ; 321.841.7303
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IRB No: S21.005.01
Protocol Abbrev: ITIL-168-101
Principal Investigator: Sajeve Samuel Thomas, MD
Phase: Drug: Phase II
Age Group: Adult
Secondary Protocol No: ITIL-168
Treatment: Lymphodepleting Chemotherapy ITIL-168/interleukin-2 (IL-2) Administration
Therapies Involved: Chemotherapy
ClinicalTrials.gov ID: NCT05050006
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Objective
The primary objective is to evaluate the efficacy of ITIL-168 in advanced cutaneous melanoma.
• Secondary and exploratory objectives will further evaluate the safety and efficacy of ITIL-168, in addition to biomarker and health-related quality-of-life parameters. -
Key Eligibility
To be eligible to participate in this study, an individual must meet the following criteria:
101. Voluntarily agreed to participate by providing informed consent in accordance with ICH, Good Clinical Practice (GCP) guidelines and applicable local regulations
102. Histologically confirmed advanced (unresectable or metastatic) cutaneous malignant melanoma
Note: Archival tissue confirmation of unresectable or metastatic melanoma is acceptable except in the case of disease recurrence after complete resection as described in eligibility criterion 103.
103. Relapsed after or refractory to at least 1 prior line of systemic therapy that must include a PD-1 blocking antibody and, if positive for proto-oncogene BRAF V600 activating mutation, a BRAF inhibitor alone or in combination with a MEK inhibitor.
Note: Treatment with an adjuvant PD-1 inhibitor satisfies the requirement for prior PD-1 treatment provided that the subject experienced biopsy-proven disease recurrence during or within 6 months of completion of a full course of adjuvant therapy.
Note: Treatment with an adjuvant BRAF inhibitor qualifies as prior BRAF inhibitor treatment, provided that the subject experienced biopsy-proven disease recurrence during or within 6 months of completion of a full course of adjuvant BRAF inhibitor a MEK inhibitor (eg, dabrafenib or vemurfenib trametinib).
Note: Subjects who have been treated with a PD-1 inhibitor for unresectable or metastatic disease must show unequivocal disease progression by meeting at least 1 of the following criteria:
• Symptomatic deterioration consistent with progression of cancer accompanied by an increase in tumor burden
• Significant new lesion(s) or significant growth of existing lesion(s) on diagnostic CT scan or MRI
Note: Subjects who have been treated with a PD-1 inhibitor for unresectable or metastatic disease and who are suspected of having disease progression but tumor growth is equivocal must repeat a diagnostic CT scan or MRI at least 4 weeks later and show at least 1 of the following:
• Continued growth of existing measurable lesion(s) amounting to at least a 5% increase in the sum of lesion diameters on repeat of a diagnostic CT scan or MRI compared with the most recent scan
• Unequivocal continued growth of unmeasurable lesions
• Confirmed presence or growth of new lesion(s) seen on the previous scan
