Background Information:
Prostate cancer, one of the most common types of cancer, becomes metastatic when it spreads to other parts of the body. Surgery or radiation alone cannot fully treat metastatic prostate cancer, so patients often undergo hormone therapy. Unfortunately, prostate cancer can develop resistance to hormone therapy and continue to progress despite ongoing treatment. This stage is known as metastatic-castration-resistant prostate cancer (mCRPC). Scientists have discovered higher levels of a protein called EZH2 in certain cancers, particularly prostate cancer, which has been shown to correlate with resistance to hormone therapy. Mevrometostat, the study medicine, blocks EZH2 and is thought to work by stopping the growth of cells with abnormal EZH2 levels, thereby delaying hormone therapy resistance and cancer progression.
Study Medicine Mevrometostat in Phase 3 Trial of Patients Diagnosed with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated with Abiraterone Acetate (Zytiga ®)
Overview
The primary objective of this clinical trial is to assess the efficacy of combining the study medicine (mevrometostat) with a standard therapy (enzalutamide) to treat metastatic castration-resistant prostate cancer (mCRPC), which will be compared to standard treatments alone (either enzalutamide or docetaxel). In the clinical trial, patients will receive:
- Study medicine (mevrometostat) AND enzalutamide
OR
- Enzalutamide or docetaxel (depending on the study doctor’s decision)
What is the Purpose?
Pfizer MEVPRO-1 (C2321014) is a randomized, open-label, multi-center clinical trial evaluating whether combining the study medicine (mevrometostat) with enzalutamide is safe and effective for treating metastatic castration-resistant prostate cancer (mCRPC) compared to a physician’s choice of either second-line androgen receptor (AR) directed therapy (enzalutamide) or docetaxel (chemotherapy). This trial targets approximately 600 participants and aims to determine if the combination of mevrometostat and enzalutamide is superior to standard treatments alone after progression on prior abiraterone acetate treatment.
What Type of Therapy is Used?
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. Hormone therapy reduces hormones or blocks their effects to treat prostate cancer. 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. By blocking the abnormal EZH2 activity in cells, mevrometostat may prevent or delay hormone therapy resistance and cancer growth and progression.
The length of study participation varies based on how the cancer responds and how well the study medicine is tolerated.
Who can Participate?
- Male adults ≥ 18 years of age
- Adults diagnosed with metastatic castration-resistant prostate cancer that has progressed despite treatment with abiraterone acetate (Zytiga®) may be eligible to participate
- Participants must not have received prior treatment with enzalutamide
- Participants must not have received chemotherapy since their cancer became castration-resistant
- These are not the only eligibility criteria for this clinical trial
Key exclusion criteria include:
- History of any other cancer in the last 3 years (except for some skin cancers or early-stage cancers that have been cured)
- Major surgery or palliative localized radiation therapy within 14 days before joining the clinical trial
- Significant heart, kidney, or liver disease
The above is not an exhaustive list. For further information please speak to the study doctor.
What’s Involved?
- Participants in the clinical trial will receive either:
- A study medicine, mevrometostat, along with a standard treatment called enzalutamide, or
- One of the standard treatments: either enzalutamide or docetaxel, based on the study doctor’s choice.
Here’s What to Expect:
- Mevrometostat: Take tablets by mouth twice a day.
- Enzalutamide: Take capsules by mouth once a day.
- Docetaxel: Receive an intravenous (IV) infusion once every three weeks.
Visits:
- You will need to visit the study site about every 2-4 weeks during study treatment and every 12 weeks during follow-up.
- Treatment cycles are every 3 weeks for docetaxel and every 4 weeks for enzalutamide groups.
- Visits will include health assessments, questionnaires, blood tests, ECGs, CT/MRI scans, and optional biopsies (if needed at screening).
Visit Schedule:
- If you are on mevrometostat and enzalutamide or just enzalutamide: two visits in the first two cycles, and then one visit per cycle after that.
- If you are on docetaxel: one visit per cycle, up to 10 cycles.
Study Timeline:
- 28-day screening period.
- Treatment period.
- 28-day safety follow-up.
- Long-term follow-up every 12 weeks until you leave the clinical trial, or it ends.
Participation Length:
- The length of your participation depends on how your cancer responds, how well you tolerate the treatment, and your choice.
- You can continue taking the study medicine until your cancer progresses or side effects become too severe.
- Participants can stay in the study if it is a clinical benefit or until the clinical trial ends. Docetaxel treatment can last up to 30 weeks.
Tracking:
- You will need to keep an electronic diary of your medication schedule.
Possible Patient Benefits
- This could slow and stop the progression of prostate cancer and potentially prolong life as determined by radiographic progression analysis.
- Patients will be under close medical supervision for safety during the clinical trial.
Possible Patient Risks
- The use of the study medicine (mevrometostat) with enzalutamide (standard treatment) may provide no benefit for preventing disease progression in patients with castration-resistant prostate cancer.
- The use of the study medicine (mevrometostat) may also cause side effects.
ORGANIZATION:
- Pfizer
- If you are interested in learning more, please go to www.Mevpro1.com
Clinicaltrials.gov Information:
- NCT Number: NCT06551324
- Title: A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men with mCRPC Who Were Previously Treated with Abiraterone
Use the “clinical trials glossary” and “dictionary” for words, phrases and treatments that you may not understand.
Register your interest or comments about this trial with PHEN
Please Note: This information is provided for educational and awareness purposes. A decision on clinical trials participation is to be made between the patient and his doctor.
