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Epigenetic Modulator

Arm A for Prostate Cancer (MEVPRO-1 Trial)

Phase 3
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization to approximately 4.5 years
Awards & highlights

Summary

Pfizer MEVPRO-1 (C2321014) is a randomized, open-label, multi-center clinical trial evaluating whether combining the study medicine (PF-06821497) with enzalutamide is safe and effective compared to physician's choice of either second-line androgen receptor (AR) directed therapy with enzalutamide or docetaxel (chemotherapy) for treating metastatic castration-resistant prostate cancer (mCRPC) after progression on prior abiraterone acetate treatment. The primary objective of this clinical trial is to assess the radiographic progression free survival (rPFS) of the combination of PF-06821497 plus enzalutamide versus physician's choice of enzalutamide or docetaxel.

Who is the study for?
This trial is for men with metastatic castration-resistant prostate cancer (mCRPC) who have previously been treated with Abiraterone Acetate. Participants should not have received certain other treatments and must meet specific health criteria.
What is being tested?
The study is testing the safety and effectiveness of a new medicine, PF-06821497, combined with Enzalutamide compared to the standard treatment choice of either Enzalutamide alone or Docetaxel chemotherapy in treating mCRPC after prior treatment failure.
What are the potential side effects?
Possible side effects may include typical reactions to cancer medications such as fatigue, nausea, hair loss from chemotherapy (Docetaxel), hormonal therapy side effects like hot flashes or sexual dysfunction (Enzalutamide), and any unknown risks from the new drug.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization to approximately 4.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization to approximately 4.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Radiographic Progression Free Survival (rPFS) assessed by blinded independent central review (BICR) per RECIST v1.1 and Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
Secondary study objectives
Change from baseline in emotional well-being per Functional Assessment of Cancer Therapy - Prostate (FACT-P)
Change from baseline in functioning well-being per Functional Assessment of Cancer Therapy - Prostate (FACT-P)
Change from baseline in health-related quality of life (HRQoL) per Functional Assessment of Cancer Therapy - Prostate (FACT-P)
+20 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm AExperimental Treatment2 Interventions
Investigational Arm A: PF-06821497 875 mg twice daily (BID) + enzalutamide 160 mg every day (QD)
Group II: Arm BActive Control2 Interventions
Comparator Arm B: Physician's choice of enzalutamide 160 mg QD or docetaxel 75 mg/m2 intravenous (IV) every 21 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
2014
Completed Phase 4
~2760

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,612 Previous Clinical Trials
12,872,437 Total Patients Enrolled
44 Trials studying Prostate Cancer
12,903 Patients Enrolled for Prostate Cancer
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,510 Previous Clinical Trials
10,048,403 Total Patients Enrolled
9 Trials studying Prostate Cancer
3,918 Patients Enrolled for Prostate Cancer
~400 spots leftby Dec 2025
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