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

Part of paid clinical trials in New York, New York.

Sponsor
Lytix Biopharma AS
Study ID
NCT04796194
Phase
PHASE2
Status
Completed

Conditions

  • Advanced Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LTX-315 in combination with pembrolizumab — COMBINATION_PRODUCT
    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.

Study Details

ATLAS-IT-05 was an open-label, single-arm study in patients with advanced melanoma accessible for injections (cutaneous, subcutaneous, lymph node, or intramuscular tumors) and who had either exhausted treatment options or were not eligible for, suitable for, or willing to undergo such treatments.

Key Dates

First listed
Mar 12, 2021
Start date
Nov 5, 2021
Status verified
Jun 2026
Primary completion
Feb 3, 2025
Completion
Jul 1, 2025

Study Design

Enrollment
23 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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 Measure

Objective Response Rate (ORR) [ Time Frame: Patients were followed throughout the treatment period of up to 24 months and then for an additional 90 days after the end of treatment. ]

Locations (4)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Levine Cancer Institute - Atrium HealthCharlotteNorth Carolina28204-
University of Pittsburgh Medical Center (UPMC) Hilman Cancer CenterPittsburghPennsylvania15232-
MD Anderson Cancer CentreHoustonTexas77030-

Related coverage on Hipa.ai

Find similar trials in New York, NY

By research site
Icahn School of Medicine at Mount Sinai· New York, NYLevine Cancer Institute - Atrium Health· Charlotte, NCUniversity of Pittsburgh Medical Center (UPMC) Hilman Cancer Center· Pittsburgh, PAMD Anderson Cancer Centre· Houston, TX

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