Pfizer MEVPRO Prostate Cancer Clinical Trials

Help advance metastatic prostate cancer treatment research

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

  • Recruiting
MEVPRO-1
For people with abiraterone-resistant metastatic prostate cancer
Clinicaltrials.gov
Clinicaltrialsregister.eu
A Phase 3 clinical trial evaluating the investigational drug (mevrometostat) in combination with enzalutamide compared to enzalutamide or docetaxel alone in adults with mCRPC previously treated with abiraterone acetate.
Study details
MEVPRO-1 is a Phase 3, randomised, open-label clinical trial to evaluate an investigational drug called mevrometostat for men with metastatic castrate-resistant prostate cancer (mCRPC) that has progressed after treatment with abiraterone acetate. MEVPRO-1 will investigate whether mevrometostat in combination with enzalutamide is superior to either enzalutamide or docetaxel in prolonging radiographic progression-free survival in the mCRPC setting.
Approximately 600 participants will be randomly assigned in a 1:1 ratio to Arm A or Arm B.
  • Investigational Arm A:
    Mevrometostat 875 mg BID plus
    enzalutamide 160 mg QD
  • Comparator Arm B:
    Study doctor’s choice of enzalutamide 160 mg QD OR
    docetaxel 75 mg/m2 IV every cycle (21 days) for up to a maximum of 10 cycles.
Participants will receive investigational treatment until radiographic disease progression, unacceptable toxicity, protocol violation, withdrawal or study termination. The length of participation in MEVPRO-1 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 and a 28- to 35-day safety follow-up. The treatment period in the study will consist of cycles of 3 weeks (docetaxel group) or 4 weeks (enzalutamide groups). Participants receiving investigational mevrometostat and enzalutamide or enzalutamide alone will attend 2 study visits in Cycles 1 and 2, then 1 study visit per cycle thereafter. Participants receiving standard-of-care docetaxel will attend 1 study visit per cycle for up to 10 cycles.
Long-term safety follow-up will consist of visits every 12 weeks from the last dose 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.
  • Evidence of disease progression on or after treatment with at least 12 weeks of abiraterone acetate in the metastatic castrate-sensitive prostate (mCSPC) cancer or first-line mCRPC setting.
  • Key exclusion criteria:
  • Treatment with chemotherapy since becoming castrate-resistant.
  • 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.
  • Prior treatment for prostate cancer at any stage with any cytotoxic chemotherapy, radioligand therapy, ARSi (including enzalutamide, apalutamide, darolutamide), PARP monotherapy or other systemic anti-cancer treatment.
  • Major surgery or palliative localised radiation therapy within 14 days before randomisation.
Thank you for considering this clinical trial for your patients.

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

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