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Brief Title: Intratumoral Injection of LTX-315 in Combination With Pembrolizumab in Advanced Melanoma
Official Title: A Phase II Study of Intratumoral Injection of LTX-315 in Combination With Pembrolizumab in Patients With Percutaneously Accessible Lesions With Advanced Melanoma Refractory to Pembrolizumab
Study ID: NCT04796194
Brief Summary: ATLAS-IT-05 is an open-label, single-arm study in patients with advanced melanoma accessible for injections (cutaneous, subcutaneous, lymph node, or intramuscular tumors) and who have either exhausted treatment options or are not eligible for, suitable for, or willing to undergo such treatments.
Detailed Description: The study aims to assess the safety and efficacy of LTX-315 in combination with the immune checkpoint inhibitor (ICI) pembrolizumab in patients with advanced melanoma. LTX-315 has been administered with pembrolizumab in a previous Phase I/II study, and there were clear indications that LTX-315 + pembrolizumab was a clinically active combination. Furthermore, the addition of LTX-315 to pembrolizumab dosing did not appear to increase the overall incidence or severity profile of toxicities. The present study will document the preliminary efficacy, clinical safety, and tolerability of LTX-315 in combination with pembrolizumab, in a dose and regimen that is considered to be safe. Patient population consists of patients with unresectable stage III B, C, D and Stage IVm1a, m1b (without liver mets) metastatic melanoma ECOG performance status of 0 or 1, who have received an FDA-approved anti-PD/PD-L1 therapy and have progressed after prior anti-PD-1 or anti-PD-L1 therapy, alone or in combination with systemic therapy.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Levine Cancer Institute - Atrium Health, Charlotte, North Carolina, United States
University of Pittsburgh Medical Center (UPMC) Hilman Cancer Center, Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Centre, Houston, Texas, United States
Centre Hospitalier Regional Universitaire De Lille, Lille, , France
Gustave Roussy Cancer Campus, Paris, , France
Hospital Lyon Sud, Pierre-Bénite, , France
Akershus University Hospital, Lørenskog, , Norway
Oslo University Hospital--Radiumhospitalet, Oslo, , Norway
Clínica Universidad de Navarra, Pamplona, , Spain
Name: Adi Diab
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR