Assessment of Pharmacokinetic Similarity of FYB206 in Comparison with Keytruda in Resected Stage II or Stage III Melanoma Patients
This clinical trial is designed for adults who have recently had stage IIB, IIC, or stage III melanoma (a serious form of skin cancer) fully removed with surgery. After surgery, patients often receive medication to help stop cancer cells from returning. This is known as adjuvant therapy. Keytruda (pembrolizumab) is an approved immunotherapy already used on the NHS for this purpose. Researchers are studying a new drug called FYB206, which is designed to be a 'biosimilar' version of Keytruda. A biosimilar is made to work in the exact same way as an existing biological medicine, offering the same safety and effectiveness. In this trial, doctors will compare how the body handles FYB206 compared to Keytruda. By taking regular blood samples, they will see how quickly each drug enters, moves through, and leaves the body. The goal is to prove both drugs behave identically.
At a glance
What is this study about?
Melanoma is a serious type of skin cancer. When melanoma reaches stage IIB, IIC, or stage III, it means the tumour was either deep in the skin or had started spreading to nearby lymph nodes. In many cases, surgeons can cut out the visible cancer completely. However, tiny microscopic cancer cells might still remain in the body, which can cause the cancer to come back later. To lower this risk, patients are often offered follow-up treatment, called adjuvant therapy.
One common adjuvant treatment is an immunotherapy drug called Keytruda (pembrolizumab). Immunotherapies work by helping your own immune system recognise and destroy hidden cancer cells. Keytruda is made from complex biological proteins. When the original patent on a biological drug expires, other companies can create 'biosimilar' versions. FYB206 is a proposed biosimilar to Keytruda.
This study is a Phase I bioequivalence trial. Its main purpose is to test whether FYB206 is processed by the human body in the same way as Keytruda. Researchers will carefully track drug levels in the blood over time. If the two medicines behave identically in the body and show the same safety profile, FYB206 could eventually give the NHS and patients another reliable, more affordable treatment option.
Key takeaways
- The trial compares a new biosimilar drug (FYB206) with Keytruda in adults with stage II or III melanoma.
- It is for patients who have already had their skin cancer completely removed by surgery.
- The study checks whether both medicines move through and leave the body in the same way.
- Every participant receives an active cancer drug; no placebos are used.
- Participation is entirely voluntary and you are free to withdraw at any time.
Who may be eligible?
This trial is open to men and women aged 18 and older who have been diagnosed with stage IIB, IIC, or stage III cutaneous (skin) melanoma.
To be considered, you must have already had surgery that completely removed the melanoma and any affected lymph nodes, leaving no visible cancer behind. You must also be planning to receive adjuvant treatment to help keep the cancer from returning.
You may not be able to take part if you have certain other serious health issues, such as active autoimmune diseases, or if your cancer could not be fully removed by surgery. Your hospital care team will run tests to confirm whether this study is safe and appropriate for your situation.
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.
- I am aged 18 or older.
- I have been diagnosed with stage IIB, IIC, or stage III skin melanoma.
- I have had surgery that completely removed the melanoma tumour.
- My doctor has recommended follow-up (adjuvant) immunotherapy treatment.
- I am able to attend regular hospital appointments for infusions and blood tests.
What does participation involve?
If you take part, you will be randomly assigned by a computer to receive either the study drug (FYB206) or the approved drug (Keytruda). Both medicines are given as a drip into a vein (an intravenous infusion), usually every few weeks at a hospital clinic.
Because this study measures how the medicine moves through your body, you will need regular blood tests before and after your infusions. The team will also check your blood pressure, heart rate, and overall wellbeing at each visit. You will have regular physical check-ups and routine scans to monitor your health. The full study duration usually lasts several months to a year, covering the treatment period and follow-up visits.
Potential risks and benefits
Locations (5)
- —UnverifiedLithuania
- —UnverifiedRomania
- —UnverifiedPoland
- —UnverifiedBulgaria
- —UnverifiedEstonia
Common questions
What is a biosimilar drug?
A biosimilar is a medicine designed to be an exact, highly similar match to an already approved biological drug. It must show the same safety, quality, and effectiveness as the original.
Will I receive a dummy drug (placebo)?
No. In this type of trial, every participant receives an active cancer medicine—either the new medicine (FYB206) or the standard treatment (Keytruda).
How is the medicine given?
Both medicines are given directly into a vein through a small drip (intravenous infusion) in a hospital day unit.
Will taking part cost me anything?
No, the study medicine and all study-related tests are free. Many trials also help cover travel and parking expenses.
Can I leave the study if I change my mind?
Yes. You have the right to leave the trial at any stage, and your regular cancer care will continue as normal.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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