A Window of Opportunity (WoO) study evaluating pembrolizumab with or without olaparib in Tertiary Lymphoid Structures (TLS)-positive selected resectable Soft Tissue Sarcoma (STS) followed by adjuvant pembrolizumab (NeoSarc)
This study, called NeoSarc, is for adults with specific types of soft tissue sarcoma, known as undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma, that can be removed by surgery. It aims to see if combining two medicines, pembrolizumab (also known as Keytruda) and olaparib, before surgery, makes the primary treatment more effective. After surgery, patients will continue to receive pembrolizumab. We want to understand how these treatments impact the cancer cells and stop the cancer from coming back. This is a Phase II study, meaning we are exploring new treatments and gathering more information about their safety and effectiveness. Researchers will compare how well the combination works compared to pembrolizumab alone.
At a glance
What is this study about?
This study is looking into better ways to treat certain types of soft tissue sarcoma. Sarcomas are rare cancers that can affect different parts of the body, often in soft tissues like muscle, fat, blood vessels, or nerves. The specific types of sarcoma this study focuses on are undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma.
Researchers are investigating whether adding a drug called olaparib to pembrolizumab (known as Keytruda) can improve treatment before surgery. Pembrolizumab is an immunotherapy, which helps your own immune system fight the cancer. The study will also explore if continuing with pembrolizumab after surgery helps prevent the cancer from returning. By looking at samples of the tumor before and after this treatment, doctors hope to understand how these medicines affect the cancer cells.
The main goal of the study is to see if these treatments can increase the number of certain immune cells (CD8+ T-cells) within the tumor. A higher number of these immune cells suggests that your body's defence system is more actively fighting the cancer. The study also aims to look at how much cancer remains after treatment, how many people respond to the treatment, and how long people stay free from cancer, as well as whether they have a good quality of life.
Key takeaways
- This study evaluates new treatments for specific soft tissue sarcomas.
- It combines pembrolizumab (Keytruda) with or without olaparib before surgery.
- Pembrolizumab continues after surgery to help prevent cancer recurrence.
- The study aims to improve immune response within the tumor.
- It's open to adults whose sarcoma can be surgically removed.
- Your health will be closely monitored throughout.
Who may be eligible?
This study is open to adults of any age, both men and women, who have been diagnosed with either undifferentiated pleomorphic sarcoma or dedifferentiated liposarcoma. Importantly, your cancer must be in a place that can be removed by surgery.
To be considered for the study, doctors will also need to check other aspects of your health and your specific cancer. This is to make sure the treatment being tested is as safe and potentially helpful for you as possible.
It's important to remember that not everyone with these types of cancer will be able to join the study. Your doctor will carefully review your medical history and test results to see if you meet all the criteria.
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 undifferentiated pleomorphic sarcoma or dedifferentiated liposarcoma?
- Can your sarcoma be removed by surgery?
- Are you able to attend regular hospital appointments and tests?
What does participation involve?
If you decide to take part in this study, you will first have a small sample of your tumour (a biopsy) taken. You will then receive the study drugs (either pembrolizumab on its own, or pembrolizumab plus olaparib) for a short period before your planned surgery. Afterwards, you will have your surgery to remove the tumour.
Following surgery, all participants will continue to receive pembrolizumab for a longer period. Throughout the study, you will have regular visits to the hospital for examinations, blood tests, and scans to monitor your health and how the treatment is working. Doctors will also take another sample of your tumour during surgery to compare it with the first one.
The total duration of your participation will involve the pre-surgery treatment, the surgery itself, and then continued pembrolizumab treatment, all followed by regular check-ups to monitor your progress over time.
Potential risks and benefits
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Common questions
What is sarcoma?
Sarcoma is a rare type of cancer that grows in the body's soft tissues, like muscles, fat, nerves, and blood vessels.
What is Keytruda (pembrolizumab)?
Keytruda is an immunotherapy drug that helps your own immune system recognise and fight cancer cells.
What is olaparib?
Olaparib is a drug that works in a different way to target cancer cells and stop them from growing.
Why is it called a 'window of opportunity' study?
This means the treatment is given for a short time before surgery, giving doctors a 'window' to see how it affects the cancer directly.
What is a Phase II study?
A Phase II study explores if new treatments are effective and gathers more information about safety, often involving a smaller group of patients.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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