A Multicenter, Open-label, Phase 2 study of Intratumoral Vidutolimod (CMP-001) in Combination with Intravenous Cemiplimab in Subjects with Selected Types of Advanced or Metastatic Cancer
This research study is looking at a new way to treat certain advanced cancers, including Merkel Cell Carcinoma, Basal Cell Carcinoma, and some breast and lung cancers. It combines two medicines: Vidutolimod, which is given directly into a tumour, and Cemiplimab (also known as LIBTAYO), which is given into a vein. This study is in an earlier stage (Phase 2), where doctors want to understand if this new combination can effectively shrink tumours and if it is safe for patients. Researchers will closely monitor volunteers to see how their cancer responds and if they experience any side effects. This helps determine if these treatments could be a good option for future cancer care.
At a glance
What is this study about?
This study is exploring a new combination of treatments for people who have advanced cancer. This means the cancer has spread from where it started. The types of cancer included in this study are Merkel Cell Carcinoma, a rare skin cancer; Cutaneous Squamous Cell Carcinoma and Basal Cell Carcinoma, which are common types of skin cancer; Triple Negative Breast Cancer, a specific type of breast cancer; and Non-Small Cell Lung Cancer, a common form of lung cancer.
The study uses two different medicines. One is called Vidutolimod, and it's given directly into a tumour. The other medicine is Cemiplimab, also known as LIBTAYO, and it's given into a vein. Doctors want to see if using these two treatments together can help shrink tumours more effectively than other treatments, and if it's a safe way to treat these cancers. This is a "Phase 2" study, which means it's an important step in finding out more about how new treatments work and if they could be helpful for more people in the future.
Throughout the study, doctors will carefully watch how your cancer responds to the treatment. They will measure the size of your tumours to see if they get smaller or if the cancer stops growing. They will also keep a close eye on any side effects you might experience. This information is really important for understanding if this treatment combination is promising and could eventually become a standard treatment option for certain cancers.
Key takeaways
- This study is testing a new combination of two cancer drugs.
- It's for adults with certain types of advanced or metastatic cancer.
- Doctors will monitor tumour size and side effects very closely.
- This is an early-stage study to understand effectiveness and safety.
- Taking part involves regular hospital visits for treatments and checks.
Who may be eligible?
To join this study, you would generally need to be an adult, 18 years or older, with a diagnosis of advanced or metastatic cancer. This means your cancer has spread from its original site.
The specific types of cancer being looked at are Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, Basal Cell Carcinoma, Triple Negative Breast Cancer, and Non-Small Cell Lung Cancer. If you have one of these types of cancer, you might be able to take part.
There will be other health checks and requirements to make sure the study treatment is suitable and as safe as possible for you. Your doctor will discuss all of these details with you to see if you're a good fit.
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 advanced or metastatic cancer?
- Is your cancer one of these types: Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, Basal Cell Carcinoma, Triple Negative Breast Cancer, or Non-Small Cell Lung Cancer?
- Are you willing to attend regular hospital appointments for treatment and check-ups?
What does participation involve?
If you decide to take part in this study, you would receive two medications: Vidutolimod and Cemiplimab (or LIBTAYO). Vidutolimod is injected directly into one of your tumours, while Cemiplimab is given through a drip into a vein, like a regular infusion. You would have regular appointments at the hospital or clinic. These visits would involve check-ups with the study doctors, blood tests, and scans (like X-rays or CT scans) to see how your cancer is responding and to monitor your general health.
The study would involve ongoing treatment and follow-up for a period of time, which your doctor will explain. This is to carefully track any changes in your cancer and any side effects you might experience. The total duration of your participation, including follow-up after the treatment phase, would be fully explained before you join.
Potential risks and benefits
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Common questions
What does 'advanced or metastatic cancer' mean?
It means the cancer has spread from where it first started to other parts of your body.
What are the treatments being tested?
Two medicines are being tested together: Vidutolimod (injected into a tumour) and Cemiplimab (given through a drip into a vein).
Is this a new treatment?
Yes, this specific combination of treatments is being studied to understand how well it works and if it's safe. It's not yet a standard treatment.
What will happen during the study?
You'll have regular treatments, check-ups, blood tests, and scans to monitor your health and how your cancer is responding.
Can I stop being in the study if I want to?
Yes, you can choose to leave the study at any time, for any reason, and it won't affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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