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-2
For people who have not tried hormonal therapy or chemotherapy for metastatic castrate-resistant prostate cancer
Clinicaltrialsregister.eu
A Phase 3 clinical trial evaluating the investigational medicine in combination with enzalutamide compared to a placebo in combination with enzalutamide in adults with mCRPC who have not tried hormonal therapy or chemotherapy in the castrate-resistant setting.
Study details
MEVPRO-2 is a Phase 3, randomized, double-blind clinical trial of an investigational medicine in combination with enzalutamide compared to a placebo in combination with enzalutamide in adults with mCRPC (metastatic castration resistant prostate cancer).
MEVPRO-2 will investigate whether investigational medicine plus enzalutamide can delay or prevent anti-androgen resistance to provide superior clinical benefit compared to enzalutamide alone in participants with mCRPC who have not tried hormonal therapy or chemotherapy in the castrate-resistant setting.
Approximately 900 participants will be randomly assigned in a 1:1 ratio to Arm A or Arm B.
  • Investigational Arm A:
    Investigational medicine 875 mg BID plus
    enzalutamide 160 mg 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-2 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 every 28 days. Participants will attend visits every 2 weeks until week 9, then every 4 weeks until week 53, and then every 8 weeks while receiving the study medicine.
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. 
  • Progressive disease in the setting of medical or surgical castration as defined by meeting 1 or more of the following 3 criteria:
    • PSA progression defined by a minimum of two rising PSA levels with an interval of ≥1 week between each determination, with a PSA value at the Screening visit being ≥2 μg/L.
    • Soft tissue disease progression as defined by RECIST 1.1.
    • Bone disease progression defined by PCWG3 with 2 or more new metastatic bone lesions on a whole-body radionuclide bone scan.
  • Key exclusion criteria:
  • Participants must be treatment naïve at the mCRPC stage, e.g., participants cannot have received any cytotoxic chemotherapy (includes but not limited to docetaxel), received ARSI/ abiraterone acetate in mCRPC, mCSPC or non-metastatic PC. Prior docetaxel in mCSPC is allowed.
  • 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 localized radiation therapy within 14 days before randomization.

Thank you for considering this clinical trial.

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

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