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Epigenetic Modulator

PF-06821497 + Enzalutamide for Prostate Cancer (MEVPRO-1 Trial)

Phase 3

Recruiting

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Surgically or medically castrated, with serum testosterone ≤50 ng/dL (≤1.73 nmol/L) at screening

Eastern Cooperate Oncology Group (ECOG) performance status 0 - 2, with life expectancy of at least 6 months as assessed by the investigator

Must not have

Hepatic dysfunction

Clinically significant cardiovascular disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up randomization to approximately 4.5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

"This trial is testing if combining PF-06821497 with enzalutamide is safe and effective for treating metastatic castration-resistant prostate cancer. The main goal is to see if this combination

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

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I am castrated with low testosterone levels.

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I can care for myself and my doctor believes I have at least 6 months to live.

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My prostate cancer is confirmed without being a small cell type.

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My cancer has spread to my bones or soft tissues, confirmed by scans.

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My prostate cancer has worsened despite treatment and castration.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have liver problems.

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I have a serious heart condition.

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My kidney function is low, with an eGFR under 45 mL/min.

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I have previously received treatments for prostate cancer, including chemotherapy or hormone therapy.

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I do not have brain metastasis or conditions that could lead to seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ randomization to approximately 4.5 years

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)

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