TACTI-003 (Two ACTive Immunotherapeutics): A multicenter, open label, randomized, Phase II trial to investigate a soluble LAG-3 fusion protein, eftilagimod alpha (efti; IMP321) in combination with pembrolizumab (PD-1 antagonist) for first line treatment of subjects with unresectable recurrent or metastatic squamous cell carcinoma of the head and neck (HNSCC)
This study, called TACTI-003, is investigating a new treatment for a type of head and neck cancer that has either come back or spread to other parts of the body. The treatment combines a new experimental drug, eftilagimod alpha (efti), with pembrolizumab (Keytruda), a drug already used to treat certain cancers. Researchers want to see if this combination treatment can shrink tumours more effectively than current approaches. It's a Phase II study, meaning it's still in the earlier stages of testing in people. Participants will be randomly assigned to receive one of the treatments, and doctors will carefully monitor their progress and side effects. Generally, adults aged 18 and over can take part.
At a glance
What is this study about?
This research study, known as TACTI-003, is designed to investigate a new way to treat a specific type of head and neck cancer called 'squamous cell carcinoma' that has either returned after initial treatment or has spread to other parts of the body. This kind of cancer can sometimes be difficult to treat, so researchers are always looking for better options.
The study combines a new, experimental drug called eftilagimod alpha (often shortened to 'efti') with a drug that is already approved and used for some cancers, called pembrolizumab (also known as Keytruda). Pembrolizumab works by helping the body's own immune system fight cancer. Efti is also designed to boost the immune system's response to cancer. The idea is that using these two drugs together might be more effective at shrinking tumours than using just one.
This is a 'Phase II' study, which means it’s an early-stage trial focusing on whether the new combination treatment works and is safe. The main goal is to see how many people respond to the treatment, meaning their tumours shrink or stop growing. Researchers will also be closely watching for any side effects and how the treatment affects participants' overall health and quality of life.
Key takeaways
- This study tests a new two-drug combination for advanced head and neck cancer.
- The drugs aim to boost your immune system to fight cancer.
- It's a Phase II study, looking at effectiveness and safety.
- You must be 18 or older with specific types of head and neck cancer.
- Participation involves regular hospital visits for treatment and monitoring.
Who may be eligible?
To be considered for this study, you must be 18 years old or older. The study is open to both men and women.
The study is specifically for people who have squamous cell carcinoma of the head and neck that has either returned after previous treatment or has spread to other parts of the body. Importantly, the doctors must consider your cancer as 'unresectable,' which means it cannot be completely removed by surgery.
There might be other health conditions or medications that could prevent someone from joining, even if they meet these main criteria. A study doctor will review all your medical information carefully to decide if this study is suitable for you.
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 head and neck squamous cell carcinoma?
- Has your cancer returned or spread to other parts of your body?
- Has your doctor told you that your cancer cannot be removed by surgery?
- Are you able to attend regular hospital appointments?
What does participation involve?
If you decide to join this study, you will receive either the combination therapy of eftilagimod alpha and pembrolizumab, or pembrolizumab alone. The drugs will be given through a drip into your arm (an infusion). You will have regular visits to the hospital or clinic for these infusions, as well as for various tests and check-ups.
These visits will include physical examinations, blood tests, and scans (like CT or MRI) to see how your cancer is responding to the treatment. You will also be asked to complete questionnaires about your quality of life. The study team will monitor you closely for any side effects. The exact number of visits and the total duration in the study will vary, but you should expect to attend frequent appointments, especially at the beginning.
Potential risks and benefits
Locations (5)
- —UnverifiedGermany
- —UnverifiedSpain
- —UnverifiedRomania
- —UnverifiedDenmark
- —UnverifiedBelgium
Common questions
What is head and neck squamous cell carcinoma?
It's a type of cancer that starts in the flat cells lining the moist surfaces inside the head and neck, such as the mouth, throat, or voice box.
What does 'unresectable' mean?
It means the cancer cannot be completely removed through surgery.
What is a 'Phase II' study?
It's an early-stage study that tests if a new treatment is effective and safe in a larger group of people after initial safety tests.
Will I know which treatment I'm getting?
Yes, this is an 'open label' study, meaning both you and your doctor will know which treatment you are receiving.
What is 'objective response rate'?
It measures how many patients have their tumours shrink or completely disappear after treatment. It's a key way to judge if a treatment is working.
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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