Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2 Study of Intratumoral Injection of LTX-315 in Combination with Pembrolizumab in Patients with Percutaneously Accessible Lesions with Advanced Melanoma Refractory to PD-1/PD-L1 Inhibitor Therapy

This research is testing a new way to treat advanced melanoma, a type of skin cancer, when standard immunotherapy hasn't worked. The study focuses on injecting a drug called LTX-315 directly into the tumour, alongside giving another existing cancer medicine called Pembrolizumab (also known as Keytruda). The main aim is to see how many people's tumours shrink or disappear, and how long people live after treatment. Researchers will also be checking how safe the combination treatment is and if there are any side effects. These types of studies are important for finding better treatments for cancers that are difficult to treat, offering hope to patients and their families.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Lytix Biopharma AS

Enrolment target

Start

26 Aug 2022

Advanced Melanoma

What is this study about?

This study is designed to explore a new treatment approach for advanced melanoma, a serious form of skin cancer. Specifically, it's for people whose melanoma has not responded to a type of treatment called PD-1/PD-L1 inhibitors (also known as immunotherapy). The main idea behind this trial is to combine two different treatments: a new drug called LTX-315, which is injected directly into the tumour, and an existing cancer drug called Pembrolizumab (Keytruda), which is given into the bloodstream.

The researchers want to see if this combination can help shrink the tumours or stop them from growing. They will be carefully measuring how well the treatment works by looking at how many people's tumours respond. They will also be very interested in the overall health and well-being of the participants, including how long people live after starting the treatment.

This is a 'Phase 2' study, which means it builds on earlier research and aims to get a better understanding of how safe and effective the new treatment combination is. Finding new and more effective treatments for advanced melanoma is incredibly important, especially for those who haven't benefited from current therapies. This study hopes to offer a new option for these patients.

Key takeaways

This study tests a new combination treatment for advanced melanoma.
It's for people whose melanoma hasn't responded to previous immunotherapy.
Treatment involves an injected drug (LTX-315) and an existing drug (Pembrolizumab).
Researchers will check if tumours shrink and monitor side effects.
Participation might offer a new treatment option, but side effects are possible.
You can leave the study at any time.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women. You must have advanced melanoma that can be reached easily with an injection and has not responded well to previous immune-boosting cancer treatments.

There will be other detailed medical checks to make sure the study is a safe and suitable option for you. These checks are important to ensure that the treatment is given to people who are most likely to benefit and who can safely take part. Your doctor will discuss all the specific criteria with you to determine if you are a good fit for this research.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have advanced melanoma?
Has your melanoma not responded to immune-boosting cancer treatments (PD-1/PD-L1 inhibitors)?
Do you have tumours that can be easily injected?
Are you willing to have regular medical checks and tests?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll receive the study drugs LTX-315 and Pembrolizumab according to a set schedule. LTX-315 will be injected directly into your tumour, while Pembrolizumab will be given through a drip into your vein. You may also be given other commonly used medicines like Cimetidine, Chlorphenamine, and Montelukast, which can help manage potential side effects or allergic reactions related to the study treatments.

Throughout the study, you'll have regular visits to the clinic for medical check-ups, blood tests, and scans to see how you're responding to the treatment and to monitor your general health. Researchers will carefully check vital signs like your heart rate, temperature, and blood pressure, and perform ECGs to monitor your heart. They'll also check the injection site for any pain, swelling, or redness. The study will continue until the end of your treatment, with follow-up to monitor your progress and health.

Potential risks and benefits

Participating in this study might offer a chance to try a new treatment combination for your advanced melanoma if other therapies haven't worked. This could potentially lead to your tumour shrinking or stopping its growth. However, like all medical treatments, there are potential risks, including side effects from the study drugs. Medicines like Cimetidine, Chlorphenamine, and Montelukast are given to help reduce some of these. You will be closely monitored by the study team, and you are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
France
—
Unverified
Norway
—
Unverified
Spain

Common questions

What is advanced melanoma?

Advanced melanoma is a serious type of skin cancer that has spread from where it first started to other parts of the body.

What does 'refractory to PD-1/PD-L1 inhibitor therapy' mean?

This means your melanoma has not responded well to a common type of cancer treatment called immunotherapy, specifically drugs that target PD-1 or PD-L1.

What is Pembrolizumab (Keytruda)?

Pembrolizumab, also known as Keytruda, is an existing immunotherapy drug that helps your immune system fight cancer.

What is LTX-315?

LTX-315 is a new drug being tested that is injected directly into the tumour.

Will I get other medicines?

You might also receive other common medicines like Cimetidine, Chlorphenamine, and Montelukast, which are used to manage possible side effects or allergic reactions.