Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365)
This research study, called KEYNOTE-365, is investigating new treatments for men with advanced prostate cancer that has spread to other parts of the body and is no longer responding to standard hormone therapy. This type of cancer is known as metastatic castration-resistant prostate cancer (mCRPC). The study is testing a drug called pembrolizumab, often given alongside other approved cancer medicines. The main goals are to check if these new combinations are safe and if they can help shrink the cancer or slow its growth. Researchers are looking at different treatment groups, each receiving a specific combination of medicines, to find the most promising approaches to improve patient care.
At a glance
What is this study about?
This study is focused on a type of advanced prostate cancer called metastatic castration-resistant prostate cancer (mCRPC). This means the cancer has spread from the prostate to other parts of your body, and hormone therapy, which is often used to treat prostate cancer, is no longer working. Finding effective treatments for mCRPC is very important to help patients live longer and improve their quality of life.
The main drug being studied here is called pembrolizumab, which is a type of immunotherapy. Immunotherapy works by helping your body's own immune system find and fight cancer cells. In this study, pembrolizumab is being tested in combination with several other established cancer treatments. The idea is that combining therapies might be more effective than using them alone. Researchers are carefully looking at how safe these combinations are and how well they work to slow down or shrink the cancer.
There are different groups within the study, and each group receives a specific combination of medicines. For example, some groups get pembrolizumab with olaparib, while others might get it with docetaxel or enzalutamide. Some groups are also testing a new drug combination featuring vibostolimab. The researchers hope that by testing these various combinations, they can discover new and better ways to treat advanced prostate cancer, ultimately leading to improved outcomes for patients.
Key takeaways
- This study is testing new drug combinations for advanced prostate cancer.
- It focuses on cancer that has spread and no longer responds to hormone therapy.
- The main drug being studied is an immunotherapy called pembrolizumab.
- The goal is to find safer and more effective treatments.
- Careful monitoring for safety and effectiveness is a key part of the study.
Who may be eligible?
To join this study, you must be an adult male, at least 18 years old, and have prostate cancer that has spread to other parts of your body and is no longer responding to hormone therapy (mCRPC). The type of prostate cancer also matters; most participants need to have a specific type called adenocarcinoma. For some parts of the study, people with a rare type of prostate cancer that has neuroendocrine cells might be able to join.
Doctors will also need to review your past medical records and possibly take a tissue sample (biopsy) from your cancer, if it hasn't been from an area that was previously treated with radiation. This helps them understand your cancer better and make sure the study treatment is suitable for you. You must also have shown that your prostate cancer has recently worsened or progressed, which might be seen through blood tests (like PSA levels) or scans.
Importantly, your doctor will check many other detailed criteria to ensure you are a good fit for the study and that it's safe for you to participate. If your cancer type doesn't quite fit, or if you've had certain previous treatments, you might not be eligible for certain parts of the study.
- Are you an adult male (18 years or older)?
- Do you have prostate cancer that has spread to other areas of your body?
- Is your prostate cancer no longer responding to hormone treatment?
- Are you willing to provide a recent tissue sample (biopsy) of your cancer?
- Has your cancer shown signs of recently getting worse (e.g., rising PSA levels)?
- Have you discussed your previous cancer treatments with the study doctor?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you are eligible and choose to take part in this study, you would receive the assigned study medications directly from the research team. These treatments are given in different ways, such as intravenous infusions (through a drip into a vein) for drugs like pembrolizumab or oral medication (pills) for others like olaparib or enzalutamide. The exact schedule and number of visits to the clinic would depend on which treatment combination you receive.
Throughout the study, you would have regular appointments for check-ups, blood tests, and scans to monitor your health, how you are responding to the treatment, and to look for any side effects. These assessments help the doctors understand if the treatment is working and if it's safe for you. The duration of your participation would vary, but typically involves a course of treatment cycles followed by ongoing monitoring.
Some parts of this study have already stopped accepting new patients. If you continue with treatment for a long time and your cancer responds very well, you might even have the option to receive further treatment infusions later on if your cancer were to show signs of returning after stopping the first course. The research team will explain the full details of what's involved, including the total expected time commitment and follow-up plan for your specific situation.
Potential risks and benefits
Locations (21)
- Call for Information (Investigational Site 2041)Aurora, United States· Recruiting
- Call for Information (Investigational Site 2091)Cleveland, United States· Recruiting
- Call for Information (Investigational Site 2094)Portland, United States· Recruiting
- Call for Information (Investigational Site 0008)Pittsburgh, United States· Recruiting
- Call for Information (Investigational Site 0019)Myrtle Beach, United States· Recruiting
- Call for Information (Investigational Site 2090)Germantown, United States· Recruiting
- Call for Information (Investigational Site 0016)Seattle, United States· Recruiting
- MSD AustraliaNorth Ryde, Australia· Recruiting
- Merck CanadaKirkland, Canada· Recruiting
- MSD DenmarkGlostrup Municipality, Denmark· Recruiting
- MSD FranceParis, France· Recruiting
- MSD Ireland (Human Health) Ltd.Dublin, Ireland· Recruiting
+9 more sites — see the official record for the full list.
Common questions
What is 'metastatic castration-resistant prostate cancer'?
It's a type of advanced prostate cancer that has spread to other parts of the body and is no longer responding to standard hormone-blocking treatments.
What is pembrolizumab?
Pembrolizumab is an immunotherapy drug that helps your body's own immune system fight cancer cells more effectively.
Why are they testing combinations of drugs?
Researchers believe that combining different cancer treatments might be more effective at fighting the cancer than using just one drug alone.
How long would I be in the study?
The length of time varies depending on your treatment group and how your body responds, but it involves regular check-ups and monitoring over months or even longer.
Can I leave the study if I change my mind?
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
Toll Free Number
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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