The MEVPRO-1 clinical trial is exploring a new potential treatment for men who have metastatic prostate cancer which is not responding to hormone therapy (abiraterone acetate, also known as Zytiga®).
The purpose of MEVPRO-1 is to see if taking the study medicine (mevrometostat) alongside a standard treatment (enzalutamide) is safe and works to slow down or stop the growth of metastatic prostate cancer compared with standard treatment alone (either enzalutamide or docetaxel).
Watch a short video about the study medicine
About mevrometostat
The study medicine is called mevrometostat and is taken as tablets by mouth twice-a-day.
Prostate cancer cells need hormones (such as testosterone) to grow and divide and can often become resistant to hormone therapy and continue to progress and spread to other parts of the body.
EZH2 is a gene that directs the production of proteins which control the growing, dividing or repairing of cells. In some people, the EZH2 gene may become abnormal or make too much of the proteins, which can cause prostate cancer cells to grow and the cancer to progress.
Mevrometostat, the study medicine, is thought to work by blocking the abnormal EZH2 activity in cells, which may help prevent or delay hormone therapy resistance and cancer growth and progression.
Who may participate
The MEVPRO-1 clinical trial may be an option for adults with metastatic castrate-resistant prostate cancer that has become resistant to hormone therapy. Specifically, participants must have previously been treated with abiraterone acetate (Zytiga®) for at least 12 weeks.
Participants can have received chemotherapy previously, but must not have received chemotherapy since their cancer became castrate-resistant.
Condition
Metastatic Prostate Cancer
Age
18+ years
Sex
Male
Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.
Get started — See if you may be eligible
Answer a 2-minute questionnaire.
A first step as you consider this study is to answer a 2-minute online questionnaire about your health and medical history. If your answers show the study might be a good fit for you, you may choose to have your contact information shared with a Pfizer Clinical Trial Contact Center Navigator.
Speak with a study representative.
If you’re interested, a Pfizer Clinical Trial Contact Center Navigator will call you and do a more detailed review of the study and your medical history to see if you may be able to participate and be referred to a study clinic that you select.
Confirm your eligibility.
Your answers to these questions will only be linked to you if your responses indicate that you may be eligible to participate in this study and you choose to share your contact information with the study team. Pfizer study team members and our partners will have access to reports containing aggregated data that will not be directly linked back to you. Only the study staff can determine if you meet the study’s eligibility criteria and are able to enroll in the study.
What to expect
Participants will be assigned randomly (like tossing a coin) to receive either:
- Study medicine (mevrometostat) AND enzalutamide
OR
- Enzalutamide OR docetaxel (depending on the study doctor’s decision)
Mevrometostat is taken as tablets by mouth twice-a-day and enzalutamide is taken as capsules by mouth once-a-day.
Docetaxel is given as an intravenous infusion once every 3 weeks.
Participants will have a visit when they stop treatment and a follow-up visit after 1 month. They will have follow-up visits or calls every 12 weeks from the end of treatment.
Length of study treatment
Depends on how the cancer responds and how well the study medicine is tolerated
Number of study visits
3 or 4 in the first 2 months, then every 3 or 4 weeks
Long-term follow up
Every 12 weeks
Frequently asked questions
Study visits may last about 2-3 hours. Participants will need to visit the study site about every 2-4 weeks during the study treatment period and every 12 weeks during follow up. Participants taking enzalutamide with or without mevrometostat will continue until their cancer worsens, they have any side effects that become too severe, they or their doctor decide they should stop, or the trial ends. Participants receiving docetaxel may be treated for up to 30 weeks.
There are no guaranteed benefits to joining a clinical trial. You will have regular visits to the study site and your health and cancer will be closely monitored for the duration of the clinical trial. Participating in clinical trials helps researchers learn more about the disease and advance potential treatment options.
Participant safety is the top priority of this clinical trial. It is possible your condition or health may improve, worsen, or stay the same. Your study doctor will discuss all the possible risks and benefits of participating with you before you choose to enroll.
Your participation in this clinical trial is completely voluntary. You can choose to stop participating at any time, for any reason. Choosing not to participate in this clinical trial will not affect your future medical care or prostate cancer treatment.
What happens at each study visit will vary, but may include questions about your medical history, medications, physical exams, blood draws, biopsies (optional), electrocardiograms (ECGs), and CT/MRI/bone scans.
