NCT04796194

Intratumoral Injection of LTX-315 in Combination With Pembrolizumab in Advanced Melanoma

A Phase 2 Study of Intratumoral Injection of LTX-315 in Combination With Pembrolizumab in Patients With Percutaneously Accessible Lesions With Advanced Melanoma Refractory to PD-1/PD-L1 Inhibitor Therapy.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Lytix Biopharma AS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Melanoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	LTX-315 in combination with pembrolizumab	Phase A Pembrolizumab will be given as 200 mg IV infusion over 30 minutes on Days 1 and 22. Phase B Pembrolizumab will be given as 400 mg IV infusion over 30 minutes every 6 weeks starting at Day 43 (3 weeks after the last dose of pembrolizumab in Phase A) until discontinuation from the study or for a maximum of 24 months' total therapy, whichever comes first.

Timeline

• Start date: 2021-06-01
• Primary completion: 2025-02-03
• Completion: 2025-07-01
• First posted: 2021-03-12
• Last updated: 2025-11-20

Locations

10 sites across 4 countries: United States, France, Norway, Spain

Regulatory

• FDA-regulated drug study