Intratumoral Injection of LTX-315 in Combination With Pembrolizumab in Advanced Melanoma — ATLAS-IT-05  

Advanced Melanoma Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Advanced Melanoma
• Melanoma

• NCT number: NCT04796194
• Study type: Interventional
• Source: Lytix Biopharma AS
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 1, 2021
• Completion date: December 31, 2024