A Randomized, Controlled, Open-Label, Phase 2 Study of Cemiplimab as a Single Agent and in Combination With RP1 in Patients With Advanced Cutaneous Squamous Cell Carcinoma [CERPASS]
This study is investigating a new approach to treating advanced cutaneous squamous cell carcinoma, a type of skin cancer that has spread or is difficult to treat. Researchers want to find out how effective a drug called cemiplimab is, both on its own and when combined with another treatment called Vusolimogene oderparepvec. They will be carefully watching to see how much tumours shrink or disappear, which they call 'response rates'. They will also be checking for any side effects to make sure the treatments are safe for patients. This is a Phase 2 study, which means it’s still in the earlier stages of testing new treatments in a larger group of people to see if they work well enough to move to bigger studies.
At a glance
What is this study about?
This research study, called CERPASS, focuses on a type of skin cancer known as cutaneous squamous cell carcinoma, specifically when it is advanced. 'Advanced' means the cancer has spread or is hard to treat with usual methods. The main goal is to test two different treatment approaches: one using a drug called cemiplimab by itself, and another using cemiplimab together with a different treatment called Vusolimogene oderparepvec. The doctors want to see if these treatments can shrink or get rid of the cancer, and how safe they are for patients.
The researchers will be looking very closely at how well the treatments work. They will use scans and physical exams to measure how much the tumours respond. A 'response' could mean the tumour shrinks, or in some cases, completely disappears. If the doctors think a tumour has completely gone away based on clinical checks, they might take a small tissue sample (a biopsy) to confirm this. This careful monitoring helps them understand if the treatments are effective.
They will also be tracking many other things, like how long patients live, how long they stay free of cancer worsening, and how the treatments affect their general well-being and quality of life. This helps paint a full picture of the benefits and any challenges of these potential new treatments. This is important research because it could lead to better ways to treat this type of advanced skin cancer.
Key takeaways
- This study explores new treatments for advanced skin cancer (cutaneous squamous cell carcinoma).
- It tests a drug, cemiplimab, alone or combined with Vusolimogene oderparepvec.
- The main aim is to see how well tumours respond and if the treatments are safe.
- This is a Phase 2 study, an earlier step in testing new medical treatments.
- Patients would have regular scans and check-ups to monitor their progress.
- Both men and women aged 18 and over can be considered for enrolment.
Who may be eligible?
To join this study, people generally need to be at least 18 years old. Both men and women can take part.
There might be other specific health requirements or conditions that would mean someone could or couldn't join. For example, sometimes studies have rules about what other medical conditions you have, if you've had certain treatments before, or how your body's organs are working. These are put in place to ensure the study is safe for everyone involved and that the results are clear.
It's important to remember that the research team will check all these details carefully to see if this study is the right fit. If you're interested, they will explain everything clearly.
- Are you 18 years old or older?
- Do you have advanced cutaneous squamous cell carcinoma (a type of skin cancer)?
- Are you willing to attend regular clinic visits and have medical tests?
- Are you happy for doctors to take blood tests and perform scans?
- Are you able to understand and agree to the study requirements?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
Taking part in this study would involve regular visits to the clinic. You would receive one of the study treatments, either cemiplimab on its own or cemiplimab combined with Vusolimogene oderparepvec, which is given as an infusion (through a drip).
You would have special medical assessments throughout the study. These could include regular scans (like CT scans) to check if your cancer is responding, blood tests, and physical examinations. These tests help the doctors understand how well the treatment is working and monitor your health carefully. If early scans show your cancer is responding, or if it's getting worse, you may have follow-up scans a few weeks later to confirm this.
In some cases, if a doctor thinks your cancer has completely disappeared, they might suggest a small biopsy (taking a tissue sample) to confirm this. The study would continue for a certain period, with ongoing check-ups for some time after you finish treatment to monitor your long-term health and any effects.
Potential risks and benefits
Locations (6)
- —Spain
- —Greece
- —Germany
- —Poland
- —Bulgaria
- —France
Common questions
What type of cancer is this study for?
This study is for people with advanced cutaneous squamous cell carcinoma, which is a type of skin cancer that has spread or is harder to treat.
What treatments are being tested?
They are testing a drug called cemiplimab, either by itself or together with another treatment called Vusolimogene oderparepvec.
What does 'Phase 2' mean?
Phase 2 means the study is in an earlier stage, testing new treatments in a larger group of people to see if they are effective and safe enough to move to bigger studies.
Will I know which treatment I'm getting?
This study is 'open-label,' which means you would generally know which treatment you are receiving.
Are there any age limits for joining?
Yes, you must be at least 18 years old to be considered for this study.
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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