Pfizer MEVPRO Prostate Cancer Clinical Trials

Help advance metastatic prostate cancer treatment research

For more information about the MEVPRO study medicine, please watch the short video below.

Explore Pfizer’s MEVPRO Clinical Trials as potential options for people with prostate cancer

  • Recruiting
MEVPRO-3
For your patients with metastatic castration-sensitive prostate cancer who have not received treatment for their castration-sensitive cancer, except for androgen-deprivation (chemical or surgical) therapy
Clinicaltrials.gov
Clinicaltrialsregister.eu
A Phase 3 clinical trial evaluating the investigational drug (mevrometostat) in combination with enzalutamide compared to a placebo in combination with enzalutamide in adults with treatment naïve mCSPC.
Study details
MEVPRO-3 is a Phase 3, randomised, double-blind clinical trial of an investigational drug called mevrometostat in combination with enzalutamide compared to a placebo in combination with enzalutamide in adults with mCSPC (metastatic castration-sensitive prostate cancer).  

MEVPRO-3 will investigate whether mevrometostat plus enzalutamide can delay or prevent anti-androgen resistance to provide superior clinical benefit compared to placebo plus enzalutamide in participants with mCSPC who have not tried novel hormonal therapy or chemotherapy in the castration-sensitive setting. 

Approximately 1000 participants will be randomly assigned in a 1:1 ratio to Arm A or Arm B.  
  • Investigational Arm A:
    Mevrometostat 875 mg twice daily (BID)
    plus enzalutamide 160 mg once daily (QD)
  • Control Arm B:
    Placebo tablets BID plus enzalutamide 160 mg QD

Participants will receive investigational treatment until radiographic disease progression, unacceptable toxicity, protocol violation, withdrawal, or study termination. The length of participation in MEVPRO-3 will vary depending on how well participants tolerate the study treatment or time to disease progression.

The study includes a 28-day screening period, the treatment period, a 28 to 35-day safety follow-up, and long-term follow-up period.
The treatment period in the study will consist of cycles every 4 weeks (28 days). Participants will attend visits every 4 weeks until Cycle 14 and then every 8 weeks thereafter while receiving the study drug. Participants will have imaging assessments every 8 weeks until Week 25, then every 12 weeks thereafter.

Long-term safety follow-up will consist of visits every 8 weeks until Week 25 then every 12 weeks thereafter until the study is complete, which may take many years, or until the participant withdraws consent. 

Participant eligibility
  • Key inclusion criteria:
  • Male participants ≥18 years of age at screening.
  • Histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell features.
  • Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan.
  • Metastatic prostate cancer documented by positive bone scan (for bone disease), or metastatic lesion(s) on CT or MRI scan (for soft tissue/visceral disease).
    • Measurable soft tissue/visceral disease (per RECIST v1.1) is required if there is not an evaluable bone lesion (per PCWG3 criteria).
    • For participants with measurable soft tissue disease only, regional lymph node disease (e.g. below aortic bifurcation) alone does not qualify the participant for the study.
    • PET and SPECT are not evaluable imaging modalities for this study.
    • A bone scan showing intense symmetric activity in the bones (referred to as a superscan) is not considered evaluable.
  • Participants must have ECOG PS 0 or 1.
  • Participants cannot have received any cytotoxic chemotherapy, ARPIs (e.g. enzalutamide, apalutamide, abiraterone acetate or darolutamide), any other systemic anticancer therapies for mCSPC, with the following exceptions:
    • ADT (chemical or surgical) must be started prior to randomisation and must continue throughout the study. Prior therapy with up to 3 months of ADT (with or without anti-androgens) is allowed with no radiographic evidence of disease progression or rising PSA levels prior to Day 1.
    • Treatment with oestrogens, cyproterone acetate or first-generation anti-androgens is allowed until randomisation, but must be discontinued prior to randomisation.
    • Participants may have received 1 course of palliative radiation or surgery for symptomatic control secondary to prostate cancer, which should be completed at least 2 weeks prior to randomisation.
      Note: Radical prostatectomy or definitive radiotherapy to the primary prostate tumour for mCSPC with curative intent is not permitted.
  • Key exclusion criteria:
  • Prior treatment with:
    • ADT in the adjuvant/neoadjuvant setting, where the completion of ADT was <12 months prior to randomisation and the total duration of ADT was >36 months.
    • ARPI’s such as abiraterone, apalutamide, darolutamide, enzalutamide or other investigational ARPI’s.
    • Cytochrome P17 enzyme inhibitors such as oral ketoconazole as anticancer treatments for prostate cancer.
    • Chemotherapy including docetaxel or immunotherapy for prostate cancer.
    • Radiopharmaceuticals (i.e. 177Lu-PSMA-617, radium-223).
    • CDK4/6 inhibitors.
    • Any other anticancer treatment for metastatic prostate cancer, excluding palliative radiotherapy/surgery and ADT as discussed above.
  • History of any other cancer in the last 3 years (except for some skin cancers or early-stage cancers that have been cured).
  • Clinically significant cardiovascular disease, renal disease or liver disease.

Please speak to the study team or a Pfizer Field Medical representative for the full eligibility criteria.

Thank you for considering this clinical trial.

Find a study site near you

The Pfizer MEVPRO Prostate Cancer Clinical Trials are taking place at research sites in multiple countries worldwide. 
To find your nearest study site, please enter your postal code and select the optimal distance to view on the map from the drop-down menu:

      Thank you for considering Pfizer’s MEVPRO Prostate Cancer Clinical Trials.

      How clinical trials work

      Steps to join a clinical trial
      Protecting your safety and privacy
      FAQ