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) Who Have Not Tried Hormonal Therapy or Chemotherapy for Metastatic Prostate Cancer
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) compared to placebo in combination with enzalutamide. In the clinical trial, all patients will receive enzalutamide and will be randomized to receive either mevrometostat or a placebo.
You will have a 50% (1/2) chance of receiving the study medicine, a 50% (1/2) chance of receiving the placebo, and a 100% chance of receiving enzalutamide. Enzalutamide is taken as capsules by mouth once-a-day while mevrometostat or placebo are taken as tablets by mouth twice-a-day. Neither you nor the study staff will know whether you are taking mevrometostat or placebo.
WHAT IS THE PURPOSE?
Pfizer MEVPRO-2 (C2321003) is a randomized, double-blind, placebo-controlled 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 placebo and enzalutamide. This trial targets approximately 900 participants and aims to determine if the addition of the study medicine to enzalutamide can delay or prevent hormone therapy resistance and increase overall survival.
WHAT TYPE OF THERAPY IS USED?
All participants will receive enzalutamide, which is the current standard treatment for this type of cancer and is taken as capsules by mouth once a day. 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
- Participants can have received treatments such as chemotherapy or hormone therapy previously, but must not have started any further treatments since their cancer became castrate-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 enzalutamide, or
- A placebo along with enzalutamide
Here’s What to Expect:
- Mevrometostat/Placebo: Take tablets by mouth twice a day.
- Enzalutamide: Take capsules by mouth once a day.
Visits:
- You will need to visit the study site about every 2-8 weeks during the study treatment and every 12 weeks during follow-up.
- Visits will include health assessments, questionnaires, blood tests, ECGs, CT/MRI scans, and optional biopsies (if needed at screening).
Visit Schedule:
You will attend clinic visits every 2 to 8 weeks during treatment, a follow-up 4-5 weeks after, then long-term follow-up every 12 weeks.
Study Timeline:
- 28-day screening period.
- Treatment period.
- 28 to 35-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.
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.Mevpro2.com
Clinicaltrials.gov Information:
- NCT Number: NCT06629779
- Title: A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.
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.
