Pfizer MEVPRO Prostate Cancer Clinical Trials

Help advance metastatic prostate cancer treatment research

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

Explore Pfizer’s MEVPRO Clinical Trials as potential options for your patients

  • Recruiting
MEVPRO-2
For your patients who have not tried hormone therapy or chemotherapy for metastatic castration-resistant prostate cancer
Clinicaltrials.gov
Clinicaltrialsregister.eu
A Phase 3 clinical trial evaluating the investigational medicine (mevrometostat) 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, randomised, double-blind clinical trial of an investigational medicine called mevrometostat 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 mevrometostat 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 hormone therapy or chemotherapy in the castration-resistant setting.
Approximately 900 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   
  • 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, 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 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 follow-up will consist of visits every 12 weeks from the 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 medical or surgical castration as defined by meeting 1 or more of the following 3 criteria:
    • Prostate specific antigen (PSA) progression defined by rising PSA of at least 2 consecutive rises in most recent PSA to be documented over a reference value (measure 1) taken at least 7 days apart within the last 12 months. If the third PSA measure is not greater than the second measure, a fourth PSA measure is required to be taken and must be greater than the second measure. The last of these PSA values obtained before randomisation must be ≥1 μg/L if qualifying only by PSA progression.
    • 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. no cytotoxic chemotherapy, radio-ligand therapy (i.e. 177Lu- PSMA-617), CDK4/6 inhibitors, 5-alpha reductase inhibitors for prostate cancer in any setting, androgen receptor signalling inhibitors (ARSi) including enzalutamide, apalutamide, darolutamide, poly ADP-ribose polymerase (PARP) monotherapy or other systemic anti-cancer treatment. Treatment with first-generation anti-androgen (ADT) agents is allowed if discontinued before the first dose of study medication. Previous 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, kidney disease or liver disease.
  • Major surgery or palliative localised radiation therapy within 14 days before randomisation.
  • Previous treatment with opioids for pain related to either primary prostate cancer or metastasis within 28 days before randomisation. 

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

Thank you for considering this clinical trial for your patients.

  • Recruiting
MEVPRO-3
For your patients with metastatic castration-sensitive prostate cancer who have not received treatment for their castration-sensitive cancer, with the exception of androgen-deprivation (chemical or surgical) therapy
Clinicaltrials.gov
Clinicaltrialsregister.eu
A phase 3 clinical trial evaluating the investigational medicine (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 medicine called mevrometostat in combination with enzalutamide compared to a placebo in combination with enzalutamide in adults with mCRPC (metastatic castration-resistant prostate cancer).  

MEVPRO-3 will investigate whether mevrometostat 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 hormone therapy or chemotherapy in the castration-resistant setting. 

Approximately 1,000 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 investigational treatment or time to disease progression.

The study includes a 28-day screening period, the treatment period and a safety follow-up lasting between 28 and 35 days.
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 medicine. 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 (according to 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 must not have received any cytotoxic chemotherapy, ARPI (e.g. enzalutamide, apalutamide, abiraterone acetate or darolutamide) or any other systemic anti-cancer therapies for mCSPC, with the following exceptions:
    • ADT (chemical or surgical) must be started prior to randomisation and must continue throughout the study. Previous 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 before 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 before 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 before randomisation and the total duration of ADT was >36 months.
    • ARPI such as abiraterone, apalutamide, darolutamide, enzalutamide or other investigational ARPI.
    • Cytochrome P17 enzyme inhibitors such as oral ketoconazole as anti-cancer 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 anti-cancer 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, kidney disease or liver disease.
  • 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 such as abiraterone, apalutamide, darolutamide, enzalutamide or other investigational ARPI.
    • Cytochrome P17 enzyme inhibitors such as oral ketoconazole as anti-cancer 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 anti-cancer 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, kidney disease or liver disease.

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

Thank you for considering this clinical trial for your patients.

Do you have patients with metastatic prostate cancer in your care?

To learn more about Pfizer’s MEVPRO Prostate Cancer Clinical Trials and how to refer potentially eligible patients, please find the nearest study sites and the contact information by entering your post code below.

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 post 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 for your patients.

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