What is the purpose of the CLEAR clinical research study?
If you were diagnosed with early-stage CSCC, please know that you are not alone in your medical journey. CSCC is the second most common type of non-melanoma skin cancer and more people have been diagnosed with it in recent years. Surgery is the usual treatment that patients have for early-stage CSCC, but it still has some limitations, and many patients experience post-surgical complications.
Currently, we are working on developing potential non-surgical treatments for early-stage CSCC. CLEAR is a clinical research study that aims to see if an investigational treatment may be effective and well-tolerated compared to surgery in adults with early-stage CSCC.
Am I eligible?
What are the study treatments?
Investigational treatment:
This investigational treatment may help the immune system fight cancer. The investigational treatment will be given by an injection into the tumour. This is called an intralesional injection.
This investigational treatment may help the immune system fight cancer. The investigational treatment will be given by an injection into the tumour. This is called an intralesional injection.
Control treatment (surgery):
Surgery is the usual treatment for patients with early-stage CSCC and it is considered the standard of care.
Surgery is the usual treatment for patients with early-stage CSCC and it is considered the standard of care.
Once the study doctor confirms that you qualify, you will be randomly assigned to 1 of 2 treatment groups: the investigational group or the control group. The treatment group into which you will be placed is decided by chance, similar to flipping a coin. If you are in the investigational group, you will receive injections of the investigational treatment. If you are in the control group, your tumour will be removed by surgery. This is to allow researchers to compare how well the investigational treatment works against the standard of care (surgery).
What can I expect if I participate?
Study participation is 100% voluntary (your choice). You will receive information on what to expect, as well as your roles and responsibilities if you join the CLEAR study. You may leave the study at any time without it affecting your regular health care.
If you join the study, there are certain things you will be expected to do. This includes attending study visits and undergoing certain assessments and procedures, such as blood draws, tumour photographs and possibly a biopsy.
The study team will discuss all of this with you.
How can I take part?
If you wish to take part in CLEAR, you can fill in a short pre-screener questionnaire to see if you may be eligible.
Am I eligible?
What else should I know?
As with all medicines, there are possible risks when taking the investigational treatment. If you qualify and choose to participate, you will be provided with an Informed Consent Form that explains any possible risks and side effects. It is also possible that the study treatment may affect you in unknown ways. Your health and safety are our top priorities and will be closely monitored throughout your participation.
There is no guarantee that you will receive a medical benefit from participating in this study. Your condition may get better, stay the same or may even get worse. You are free to withdraw from the study for any reason and at any time.
This clinical trial will use an investigational drug product, the safety and efficacy of which has not been fully evaluated by Regulatory Authorities.
Find a study site near you
To find out more about the CLEAR study, and whether it may be right for you, please contact your closest study site – they will be more than happy to help.
English (Australia) 
English (United States)