Intratumoral Injection of LTX-315 in Combination With Pembrolizumab in Advanced Melanoma
- Conditions
- Advanced Melanoma
- Registration Number
- NCT04796194
- Lead Sponsor
- Lytix Biopharma AS
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Objective response rate (ORR) Through study completion, an average of 6 months ...defined as the proportion of patients who achieved partial response (PR) and/or complete response (CR) per local investigator assessment using RECIST version 1.1.
Clinical benefit rate (CBR) Through study completion, an average of 6 months ...defined as the proportion of patients who respond to treatment, estimated as the proportion of patients who achieve stable disease (SD), PR, or CR per local investigator assessment using RECIST version 1.1
Overall survival (OS) Through study completion, an average of 6 months ...evaluated as time from baseline until death
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
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
Icahn School of Medicine at Mount Sinai🇺🇸New York, New York, United States