A Randomized, Phase 2 Study of Pembrolizumab And Chemotherapy With or Without MK-4830 as Neoadjuvant Treatment for High-Grade Serous Ovarian Cancer
This study is for women with advanced ovarian, fallopian tube, or primary peritoneal cancer. Researchers are testing a new approach to treatment given before surgery, often called 'neoadjuvant' treatment. They want to see if adding new drugs, like pembrolizumab (Keytruda) or MK-4830, to standard chemotherapy (carboplatin and paclitaxel) can shrink tumours more effectively. The main way they'll check this is by looking for tiny bits of cancer DNA in a blood sample, which is a very early sign of how well the treatment is working. They'll also monitor tumour shrinkage during surgery and check for any side effects. This research aims to find better ways to treat these cancers.
At a glance
What is this study about?
This study is focusing on advanced ovarian, fallopian tube, and primary peritoneal cancers. These cancers are often treated with surgery, followed by chemotherapy. However, sometimes doctors give chemotherapy first, before surgery, to shrink the tumours and make the surgery more effective. This is called 'neoadjuvant' treatment.
In this study, researchers are exploring if adding new drugs to the standard chemotherapy given before surgery can improve how well the treatment works. They are particularly interested in drugs like pembrolizumab (which you might know as Keytruda) and MK-4830. Pembrolizumab works by helping your own immune system fight the cancer. MK-4830 also targets cancer cells in a different way. By combining these with standard chemotherapy, the hope is to shrink the tumours more effectively before surgery.
A key part of this study involves looking at your blood for tiny fragments of cancer DNA. This is a very sensitive test that can show how the cancer is responding to treatment much earlier than traditional methods. Researchers will also be checking how much the tumours have shrunk during surgery and keeping a close eye on any side effects to make sure the treatments are safe.
Key takeaways
- Tests new drugs combined with standard chemotherapy before surgery.
- Uses a special blood test (ctDNA) to check treatment success early.
- Aims to improve outcomes for advanced ovarian, fallopian tube, and primary peritoneal cancers.
- Involves close monitoring for tumour changes and side effects.
- Open to women aged 18 and over.
Who may be eligible?
This study is specifically designed for women aged 18 or older who have been diagnosed with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. These are related cancers that often require similar treatments.
To join, you would need to meet certain medical criteria, which a doctor involved in the study would discuss with you in detail. This ensures that the treatment is suitable and safe for you, and that the study results are meaningful.
There will also be some reasons why you might not be able to join, such as having other serious health conditions or having received certain treatments recently. Your doctor will carefully review your medical history to see if this study is a good fit for you.
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 ovarian, fallopian tube, or primary peritoneal cancer?
- Are you a woman?
- Are you able to attend regular hospital visits for treatment and check-ups?
What does participation involve?
If you decide to take part in this study, you would receive treatments including chemotherapy and potentially one of the new study drugs. These treatments would be given before any planned surgery. You would have regular visits to the hospital for infusions, blood tests, and check-ups to monitor your health and how the treatment is working. This will involve giving blood samples to check for circulating tumour DNA, which helps doctors understand the treatment's effect.
Doctors would closely watch for any side effects you might experience. After your pre-surgery treatment, you would likely have surgery followed by more standard care as needed. The total duration of your participation could vary, but it would involve a period of active treatment before surgery, followed by careful monitoring. You would be given a detailed schedule of visits and procedures if you consider joining.
Potential risks and benefits
Locations (4)
- —UnverifiedItaly
- —UnverifiedSpain
- —UnverifiedPoland
- —UnverifiedBelgium
Common questions
What is 'neoadjuvant treatment'?
This is treatment, like chemotherapy, given before surgery to shrink the tumour and make the operation easier or more effective.
What is 'Keytruda'?
Keytruda is a brand name for a drug called pembrolizumab, which helps your immune system fight cancer cells.
How will doctors know if the treatment is working?
They will take blood samples to look for tiny pieces of cancer DNA, and also check how much the tumour has shrunk during surgery.
Are there new drugs involved in this study?
Yes, the study is looking at adding new drugs like pembrolizumab and MK-4830 to standard chemotherapy.
What kind of cancers is this study for?
It's for advanced ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.
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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