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

Duration: 6 months

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of treatments for people with advanced melanoma, a type of skin cancer that has spread and is difficult to treat. It uses two drugs, LTX-315 (an experimental treatment) and pembrolizumab, to determine if they can work together to shrink tumors that cannot be removed through surgery or treated with radiation. Ideal participants are those with melanoma who have already tried other treatments, such as anti-PD-1 or anti-PD-L1 therapies, and still have tumors that can be safely injected. As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group of people.

Is there any evidence suggesting that LTX-315 and pembrolizumab are likely to be safe?

Research shows that patients generally tolerate the combination of LTX-315 and pembrolizumab well. Studies have found that injecting LTX-315 directly into tumors, along with pembrolizumab, is mostly safe. While not every possible side effect is detailed, the research suggests that this treatment does not cause serious or unexpected issues for most people. Early results also indicate potential benefits, which is encouraging for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about LTX-315 combined with pembrolizumab for advanced melanoma because this approach offers a unique mechanism of action. Unlike traditional treatments that often target melanoma cells indirectly, LTX-315 is injected directly into the tumor, breaking down cancer cell membranes and triggering an immune response. When combined with pembrolizumab, an immune checkpoint inhibitor, the treatment enhances the body's ability to recognize and destroy cancer cells. This combination has the potential to boost the effectiveness of existing immunotherapies, providing renewed hope for patients with advanced melanoma.

What evidence suggests that LTX-315 in combination with pembrolizumab could be effective for advanced melanoma?

Research has shown that using LTX-315 with pembrolizumab may help treat advanced melanoma. One study found that more than 34% of patients with advanced melanoma were still alive ten years after receiving pembrolizumab, proving its effectiveness. In this trial, participants will receive a combination of LTX-315, injected directly into tumors, and pembrolizumab. LTX-315 has shown early signs of effectiveness and is generally safe when used with pembrolizumab. This combination has demonstrated initial success in shrinking tumors, offering hope to those with few treatment options. ^{2 4 6 7 8}

Who Is on the Research Team?

Adi Diab

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intratumoral injections of LTX-315 in combination with pembrolizumab IV infusions

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. merck.com merck.com/news/ten-year-data-for-mercks-keytruda-pembrolizumab-demonstrates-sustained-overall-survival-benefit-versus-ipilimumab-in-advanced-melanoma/

Ten-Year Data for Merck's KEYTRUDA® (pembrolizumab ... At 10 years, more than one-third (34.0%) of patients with advanced melanoma were alive after treatment with KEYTRUDA, compared to 23.6% of patients treated ...

2. annalsofoncology.org annalsofoncology.org/article/S0923-7534(23)03027-2/pdf

1051P Intratumoral injection of LTX-315 in combination ... Conclusions: Intratumoral LTX-315 administration in combination with pem- brolizumab appears to be well tolerated and showed preliminary efficacy in patients.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10732595/

LTX-315 and adoptive cell therapy using tumor-infiltrating ... Standard treatment for advanced STS is chemotherapy, but even with treatment the median overall survival is approximately 14–17 months. Thus, ...

4. clinicaltrials.eu clinicaltrials.eu/trial/study-of-ltx-315-and-pembrolizumab-for-patients-with-resectable-stage-iii-iv-melanoma/

Study of LTX-315 and Pembrolizumab for Patients with ... This clinical trial investigates the efficacy and safety of LTX-315 and pembrolizumab in shrinking resectable stage III-IV melanoma tumors ...

5. sciencedirect.com sciencedirect.com/journal/ejc-skin-cancer/vol/3/suppl/S1?page=3

EJC Skin Cancer | EADO Congress 2025 - Book of Abstracts A-331 - Neoadjuvant LTX-315 in combination with pembrolizumab in resectable stage III/IV melanoma (NeoLIPA trial): Protocol for a single ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04796194

NCT04796194 | Intratumoral Injection of LTX-315 in ... The present study will document the preliminary efficacy, clinical safety, and tolerability of LTX-315 in combination with pembrolizumab, in a dose and regimen ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04796194?cond=LTX-315&viewType=Table&rank=1

Intratumoral Injection of LTX-315 in Combination With ... A phase of research to describe clinical trials that gather more information about a drug's safety and effectiveness by studying different populations and ...

8. withpower.com withpower.com/trial/phase-3-neoplasms-5-2021-45a2a

LTX-315 + Pembrolizumab for Advanced Melanoma ... 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' ...