A Phase I Open-Label, Dose-escalation Clinical Trial of Tumor Necrosis Factor Alpha and Interleukin-2 Coding Oncolytic Adenovirus TILT-123 in combination with avelumab in injectable solid tumor patients (melanoma and SCCHN) refractory to or progressing after anti-PD(L)1 immunotherapy
This is an early-stage medical study, called a Phase 1 trial, looking into a new treatment. It's for adults with advanced skin cancer (melanoma) or head and neck cancer (SCCHN) that has either stopped responding to, or gotten worse after, a type of immune system treatment called anti-PD(L)1 immunotherapy. The study treatment combines two things: an altered virus called TILT-123, which is designed to attack cancer cells, and a drug called avelumab. Researchers want to find out if this combination is safe and what the best dose is. They will also look at how well it might work against the cancer.
At a glance
What is this study about?
This study is a Phase 1 clinical trial, which means it's one of the first times this new treatment combination is being tested in people. The main goals at this stage are to make sure the treatment is safe and to find the highest dose that can be given without causing too many side effects. Researchers will also start to see if the treatment has any effect on the cancer.
The treatment being tested combines two different approaches. One is TILT-123, which is a modified virus. This virus is specially designed to target and destroy cancer cells while leaving healthy cells alone. It also helps to boost the body's own immune system to fight the cancer. The other part of the treatment is a drug called avelumab, which is an existing immunotherapy that helps the immune system recognise and attack cancer.
This study is for people with two specific types of cancer: melanoma (a serious kind of skin cancer) and squamous cell carcinoma of the head and neck (SCCHN). Importantly, it's for those whose cancer has either not responded to previous immunotherapy treatments (specifically anti-PD(L)1 medicines) or has started to grow again after these treatments. By combining TILT-123 with avelumab, doctors hope to find a new way to help people whose cancer is currently difficult to treat.
Key takeaways
- Tests a new virus-based treatment (TILT-123) with an existing drug (avelumab).
- Aimed at advanced melanoma and head/neck cancers not responsive to prior immunotherapy.
- Phase 1 study focused on safety and finding the best dose.
- Potential for a new treatment option for difficult-to-treat cancers.
- Participation involves regular hospital visits and medical checks.
Who may be eligible?
To join this study, you must be 18 years old or older. Both men and women can take part.
You would be considered for this study if you have melanoma (a type of skin cancer) or squamous cell carcinoma of the head and neck (a type of head and neck cancer). A key requirement is that your cancer has not responded well to, or has gotten worse after, receiving a specific type of immunotherapy called anti-PD(L)1 treatment in the past.
There will be other detailed health checks to make sure the study treatment is safe for you, such as checks on your general health, organ function, and any other medical conditions you might have. The study doctors will go through all these details with you to see if you are a good fit for the trial.
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 melanoma or a type of head and neck cancer?
- Has your cancer either not responded or gotten worse after anti-PD(L)1 immunotherapy?
- Are you able to travel to study appointments?
What does participation involve?
If you decide to take part, you'll have regular hospital visits for check-ups, treatment, and tests. These tests might include blood samples, scans (like CT or MRI), and possibly biopsies (small tissue samples) to see how your body is reacting to the treatment and if the cancer is changing. The specific details of how often you visit and for how long will be explained by the study team.
You will receive the study medication as prescribed by the doctors. The total time you spend in the study can vary. Sometimes, you'll continue treatment as long as it's helping and not causing severe side effects, followed by a period of follow-up where doctors will monitor your health even after treatment stops.
Potential risks and benefits
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Common questions
What is a Phase 1 clinical trial?
A Phase 1 trial is the first step where a new treatment is tested in people. The main goals are to check its safety and find the right dose, rather than seeing how well it works yet.
What is TILT-123?
TILT-123 is a special virus that has been changed so it can find and destroy cancer cells, and also help your immune system fight the cancer.
What is avelumab?
Avelumab is a type of immunotherapy that helps your body's immune system recognise and attack cancer cells more effectively.
Who is this study for?
This study is for adults with advanced melanoma or a type of head and neck cancer that has stopped responding to or gotten worse after previous anti-PD(L)1 immunotherapy treatments.
Can I stop participating in the study at any time?
Yes, you can choose to leave the study at any point, and it won't affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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