BelieveIT-201: A Randomized, Phase 2, Open-label Trial of TransCon TLR7/8 Agonist in Combination with Pembrolizumab, TransCon TLR7/8 Agonist in Combination with TransCon IL-2 β/γ, or Pembrolizumab Monotherapy as Neoadjuvant Therapy in Participants with Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)
This study, called BelieveIT-201, is exploring new treatments for a specific type of head and neck cancer (Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma) that can be removed by surgery. Researchers are comparing different approaches before surgery: one new medicine called TransCon TLR7/8 Agonist combined with another medicine called pembrolizumab, or TransCon TLR7/8 Agonist combined with TransCon IL-2 β/γ. They are also looking at pembrolizumab on its own. The main aim is to see how much the cancer shrinks after these treatments before surgery. This research is important because it could lead to better ways to prepare patients for surgery and potentially improve their outcomes.
At a glance
What is this study about?
This study is called BelieveIT-201 and it's looking into new ways to treat a specific type of head and neck cancer. This cancer is quite advanced (Stage III-IVA) but doctors believe it can still be removed by surgery. The study focuses on giving treatments *before* surgery, which doctors call "neoadjuvant therapy." The main idea is that if we can shrink the cancer effectively before surgery, it might make the surgery more successful or improve the patient's overall outcome.
Researchers are comparing three different treatment approaches. One approach involves a new medicine called TransCon TLR7/8 Agonist given together with another medicine called pembrolizumab (which you might know as KEYTRUDA). Another approach combines TransCon TLR7/8 Agonist with a different new medicine called TransCon IL-2 β/γ. The third approach uses only pembrolizumab. The study is trying to understand which of these treatments, or combinations, works best to reduce the cancer before surgery.
The main thing the doctors will be checking is how much the cancer has shrunk or disappeared in the removed tissue after these treatments, before surgery. They will also look at other important things like how long people live without their cancer coming back, how long people live overall, and any side effects the treatments might cause. This is a "Phase 2" study, which means it's still in the earlier stages of testing new treatments to see if they are safe and effective.
Key takeaways
- This study is testing new treatments for a specific type of advanced head and neck cancer before surgery.
- It aims to see if these new medicines can effectively shrink the cancer.
- Different combinations of new medicines and an existing drug are being compared.
- Participant safety and how well the treatment shrinks the cancer are key measures.
- This is an early-stage study (Phase 2) looking for promising new options.
- You have the right to withdraw from the study at any time.
Who may be eligible?
To be considered for this study, you would need to have been diagnosed with a specific type of head and neck cancer that is considered advanced (Stage III-IVA) but can still be removed by surgery. The doctors would need to confirm that your cancer meets these specific criteria.
Both men and women are welcome to take part in this study. You would also need to be at least 18 years old, and there is no upper age limit, meaning older adults can also participate if they meet the other health requirements.
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 at least 18 years old?
- Have you been diagnosed with advanced (Stage III-IVA) head and neck squamous cell carcinoma?
- Do doctors believe your cancer can be removed by surgery?
- Are you willing to potentially receive various combinations of study drugs before surgery?
What does participation involve?
If you decide to take part in this study, you would be randomly assigned to receive one of the three treatment approaches discussed earlier. This is like flipping a coin to decide which group you are in. You would receive injections or infusions of the study medicines as determined by the treatment plan.
The study would involve regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how the treatment is working. Doctors would closely watch for any side effects. After your treatment before surgery, you would undergo surgery to remove the cancer. Following surgery, there would be continued follow-up appointments to monitor your recovery and long-term health. The total duration of your involvement could vary, but it would include the treatment phase, surgery, and a period of ongoing monitoring.
Potential risks and benefits
Locations (5)
- —UnverifiedSpain
- —UnverifiedHungary
- —UnverifiedPoland
- —UnverifiedGermany
- —UnverifiedItaly
Common questions
What kind of cancer is this study for?
This study is for a specific type of advanced head and neck cancer (Stage III-IVA) that doctors believe can still be removed with surgery.
What does 'neoadjuvant therapy' mean?
It means the treatment is given *before* surgery to try and shrink the cancer first, which might make the surgery more effective.
What are the main treatments being tested?
The study tests different combinations of new medicines, including TransCon TLR7/8 Agonist, TransCon IL-2 β/γ, and a known medicine called pembrolizumab (KEYTRUDA).
How will doctors know if the treatment is working?
They will mainly check how much the cancer has shrunk or disappeared in the tissue removed during surgery.
Can I choose which treatment I receive?
No, you would be randomly assigned to one of the treatment groups, like a lottery system.
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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