Prospective, non randomized, Phase II study on MK-3475 in recurrent, platinum-resistant, CPS ≥1 positive ovarian, Fallopian tube and primary peritoneal cancer patients
This Phase II clinical trial is looking at a drug named Keytruda (pembrolizumab) for women with ovarian, fallopian tube, or primary peritoneal cancer. It is designed for patients whose cancer has come back and is no longer responding well to standard platinum-based chemotherapy (known as platinum-resistant cancer). Keytruda is an immunotherapy. Instead of attacking cancer cells directly like standard chemotherapy, it helps your own immune system recognize and fight the cancer. To take part, a patient's tumour must have a positive score (CPS 1 or higher) for a protein called PD-L1. The main goal of the trial is to see if Keytruda helps patients live longer. Researchers will also check how well the drug shrinks tumours, how long it keeps the cancer from growing, what side effects occur, and how the treatment affects everyday quality of life.
At a glance
What is this study about?
Ovarian, fallopian tube, and primary peritoneal cancers are closely linked conditions that affect the female reproductive system and the lining of the abdomen. Standard treatment usually involves surgery and platinum-based chemotherapy. While these treatments often work well at first, the cancer can sometimes come back and stop responding to platinum drugs. When this happens, doctors need new and better treatment options.
This trial is testing a medicine called Keytruda (also known as pembrolizumab). Keytruda is a type of immunotherapy. It works by blocking a signal that cancer cells use to hide from your body's natural defences. By turning this signal off, Keytruda helps your own immune system find and attack the cancer cells.
The study focuses on patients whose tumours have a specific marker called PD-L1, measured using a 'CPS' score. If your score is 1 or higher, it means your tumour has the targets that Keytruda is designed to find. Researchers want to see whether giving this drug can safely shrink tumours, keep the cancer under control, and ultimately help women live longer, fuller lives.
Key takeaways
- Tests an immunotherapy drug called Keytruda (pembrolizumab) given by an intravenous drip.
- Aimed at women with ovarian, fallopian tube, or peritoneal cancer that has returned.
- Designed specifically for cancers that no longer respond well to platinum chemotherapy.
- Requires a tumour biomarker score (CPS) of 1 or higher to take part.
- Measures if the drug helps patients live longer, improves quality of life, and manages tumours safely.
Who may be eligible?
This trial is for adult women aged 18 and over who have been diagnosed with cancer of the ovary, fallopian tube, or peritoneum.
To be considered, your cancer must have returned after previous chemotherapy and must be classified as 'platinum-resistant'. This generally means the cancer began growing again within six months of finishing a platinum-based chemotherapy treatment.
Your tumour tissue will also need to be tested in a laboratory for a specific protein marker. Only patients whose tumours test positive with a 'CPS' score of 1 or more are eligible. Your hospital care team can check your previous medical records or test a tissue sample to see if you meet these requirements.
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.
- I am a woman aged 18 or older.
- I have ovarian, fallopian tube, or primary peritoneal cancer.
- My cancer has returned after prior chemotherapy.
- My cancer is considered platinum-resistant by my doctor.
- My tumour sample tests positive for the PD-L1 marker (CPS score of 1 or higher).
What does participation involve?
If you take part, you will receive Keytruda as a liquid medicine given directly into a vein through a drip (an intravenous infusion). This is usually done in the hospital day unit every few weeks. Before each treatment, you will have routine checks such as blood tests, blood pressure measurements, and a review of any symptoms.
During the study, you will have regular imaging scans (such as CT scans) so doctors can monitor how your cancer is responding to the medicine. You will also be asked to fill out short questionnaires about your daily wellbeing and quality of life. The trial team will keep track of your health for as long as you are on the treatment and will continue to check in on you regularly afterwards to see how you are getting on.
Potential risks and benefits
Locations (1)
- —UnverifiedItaly
Common questions
Is Keytruda a type of chemotherapy?
No, Keytruda is an immunotherapy. Chemotherapy kills rapidly growing cells directly, whereas immunotherapy trains your own immune system to recognise and fight cancer cells.
What does 'platinum-resistant' mean?
It means the cancer has returned or started growing again within six months of receiving standard platinum-based chemotherapy drugs, such as carboplatin or cisplatin.
What is a CPS score?
CPS stands for Combined Positive Score. It is a laboratory test on a tumour sample that measures how much of a protein called PD-L1 is present. A score of 1 or higher is needed for this study.
Will I have to pay to take part?
No, clinical trial medicines and study-related tests are provided free of charge, and taking part will not cost you anything.
What happens if I change my mind after joining?
You can leave the trial at any time for any reason. Your medical team will support your decision and discuss other treatment options with you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.