LTX-315 + Pembrolizumab for Advanced Melanoma

(ATLAS-IT-05 Trial)

Recruiting at 9 trial locations

Overseen By Øystein Rekdal

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Lytix Biopharma AS

Must be taking: Anti-PD-1, Anti-PD-L1

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Ocular melanoma, CNS metastases, Cardiac disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

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

I have a skin or muscle tumor that can be safely injected and is the right size.

My cancer cannot be treated with more surgery or radiation.

I have at least one tumor that can be measured and won't be treated with LTX-315 or biopsied.

Exclusion Criteria

I may need surgery or radiation to relieve my cancer symptoms.

You are allergic to certain types of medications used to treat allergies and stomach issues.

I haven't had cancer immunotherapy in the last 4 weeks or have recovered from its side effects.

Treatment Details

Interventions

• LTX-315
• Pembrolizumab

Trial Overview The trial is testing LTX-315 injections directly into the tumor in combination with pembrolizumab for patients whose melanoma has spread and isn't responding to standard treatments. It's an open-label study meaning everyone knows what treatment they're getting; there's no placebo group.

Participant Groups

Group I: LTX-315 in combination with pembrolizumab Experimental Treatment 1 Intervention

LTX-315 will be injected directly into the selected tumor lesion(s). Pembrolizumab will be dispensed and administered as an IV infusion.

Who Is Running the Clinical Trial?

Lytix Biopharma AS

Lead Sponsor

Trials

9

Recruited

420+

Covance

Industry Sponsor

Trials

124

Recruited

13,300+

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

Trials

32

Recruited

18,800+

OWL

Collaborator

Trials

1

Recruited

20+