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-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 castration-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 across approximately 174 investigational sites 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. 
*Docetaxel is given in combination with prednisone or prednisolone, 5 mg BID for 21 days, and premedication of oral dexamethasone 8 mg at 12 hours, 3 hours, and 1 hour (or IV dexamethasone per standard of care) before the docetaxel infusion. 
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 safety follow-up visit that occurs within 28-35 days of treatment discontinuation and the long term follow-up period. 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 safety follow-up visit 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 (neuroendocrine differentiation and other histologic components are permitted if adenocarcinoma is the primary histology).
  • Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan.
  • Progressive disease in the setting of surgical or medical castration as defined by 1 or more of the following 3 criteria:
    • PSA progression defined as a minimum of two rising PSA levels with an interval of ≥1 week between each determination, within the last 12 months. The PSA value at the Screening must be ≥1 ng/mL if confirmed rise in PSA is the only indication of progression per PCWG3 criteria;
    • Soft tissue disease progression as defined by RECIST v1.1.
    • Bone disease progression defined by PCWG3 with 2 or more new metastatic bone lesions on a whole-body radionuclide bone scan.
  • Note: Evidence of disease progression upon treatment for at least 12 weeks with abiraterone acetate in the metastatic castration-sensitive prostate (mCSPC) cancer or first-line mCRPC setting.
  • Key exclusion criteria:
  • Treatment with cytotoxic chemotherapy, radioligand therapy (i.e. 177Lu-PSMA-617, radium-223), ARSI, PARP monotherapy or other systemic anticancer treatment (approved or experimental compounds such as antibody therapy immunotherapy, gene therapy, angiogenesis inhibitors, CDK4/6 inhibitors, EZH2 inhibitors) since becoming castration-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.

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 postcode and select the optimal distance to view on the map from the drop-down menu:

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