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

NCT04796194 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-11-20

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Lytix Biopharma AS

    lead INDUSTRY

Principal Investigators

  • Oystein Rekdal, PHD · Lytix Biopharma

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2025-02-03
Completion
2025-07-01
FDA Drug
Yes

Countries

  • United States
  • France
  • Norway
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04796194 on ClinicalTrials.gov