At a glance
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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.
In Brief
A Phase 2 clinical trial evaluating LTX-315 in combination with pembrolizumab for Advanced Melanoma. Completed, enrolled 23 participants across 10 sites in 4 countries.
Detailed 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.
Study Details
Timeline
Interventions
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.