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

Phase 2

Active, not recruiting

• Conditions: Advanced Melanoma
• Interventions: Combination Product: LTX-315 in combination with pembrolizumab

• 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.

Study Timeline

• Study First Submitted: 2021-03-02
• Study First Submitted QC: 2021-03-11
• Study First Posted: 2021-03-12
• Study Start: 2021-06-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-11-08
• Last Update Posted: 2023-11-09
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LTX-315 in combination with pembrolizumab	LTX-315 in combination with pembrolizumab	LTX-315 will be injected directly into the selected tumor lesion(s). Pembrolizumab will be dispensed and administered as an IV infusion.

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	Through study completion, an average of 6 months	...evaluated as time from baseline until death
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

Trial Locations

Locations (10)

Levine Cancer Institute - Atrium Health; 🇺🇸 Charlotte, North Carolina, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

Oslo University Hospital--Radiumhospitalet; 🇳🇴 Oslo, Norway

Clínica Universidad de Navarra; 🇪🇸 Pamplona, Spain

Gustave Roussy Cancer Campus; 🇫🇷 Paris, France

Akershus University Hospital; 🇳🇴 Lørenskog, Norway

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

Hospital Lyon Sud; 🇫🇷 Pierre-Bénite, France