LTX-315 + Pembrolizumab for Advanced Melanoma
(ATLAS-IT-05 Trial)
Trial Summary
What is the purpose of this trial?
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.
Research Team
Adi Diab
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
Adults with advanced melanoma that's not removable by surgery or treatable with radiation, who've tried and progressed after anti-PD-1/PD-L1 therapy. They must have a life expectancy of at least 3 months, be willing to undergo biopsies, use contraception if of childbearing potential, and cannot be pregnant or breastfeeding. Excluded are those with ocular/mucosal melanoma, excessive tumor burden, certain allergies/hypersensitivities, serious illnesses like HIV/hepatitis B/C (unless treated), heart issues, CNS metastases/meningitis.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intratumoral injections of LTX-315 in combination with pembrolizumab IV infusions
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- LTX-315
- Pembrolizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lytix Biopharma AS
Lead Sponsor
Covance
Industry Sponsor
Dr. Paul Kirchgraber
Covance
Chief Executive Officer since 2019
MD
Dr. Robert Dow
Covance
Chief Medical Officer since 2020
MD
Laboratory Corporation of America
Industry Sponsor
OWL
Collaborator