Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT 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 stage III B, C, D and Stage IVm1a, m1b unresectable metastatic melanoma with 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.
Study:
NCT04796194
Study Brief:
Protocol Section:
NCT04796194