Mevrometostat and Enzalutamide for Prostate Cancer
This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking Enzalutamide Alone in Participants With mCSPC Who Are ARPI naïve.
Recruiting
Phase 3Interventional Study
Metastatic Castration Sensitive Prostate Cancer (mCSPC)Hormone Sensitive Prostate CancerProstate CancerCancer of the Prostate
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,000 (estimated)
Sponsor
Pfizer · Industry
Who this trial is looking for
This trial is looking for men with metastatic hormone-sensitive prostate cancer who have not yet received chemotherapy. Participants will take a combination of two drugs, mevrometostat and enzalutamide, or just enzalutamide alone.
Are You a Good Fit for This Trial?
Must not be taking5-alpha reductase inhibitors
Rules you outSignificant cardiovascular diseaseActive brain metastasis
You may be able to join if
I am a man aged 18 or older.
I have been diagnosed with prostate cancer.
I have metastatic prostate cancer shown by scans.
I have recovered from previous treatments.
I have an ECOG performance status of 0 or 1.
You may not be able to join if
I have a serious medical or psychiatric condition.
I have significant heart disease.
I have known or suspected brain cancer.
I have received any chemotherapy for my prostate cancer.
I have used certain drugs that interact with the study medications recently.
I have not fully recovered from any recent surgery.
I have allergies to the study drugs.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This study will explore whether a combination of the investigational drug mevrometostat (PF-06821497) and enzalutamide will work better than taking enzalutamide alone in participants with mCSPC who are ARPI naïve and have not yet received chemotherapy in the mCSPC setting.
Trial Locations
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Eligibility Criteria
Inclusion Criteria
* Male participants aged ≥18 years (or the minimum age of consent in accordance with local regulations) at screening.
* Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features.
* Metastatic prostate cancer documented by positive bone s…
Inclusion Criteria
* Male participants aged ≥18 years (or the minimum age of consent in accordance with local regulations) at screening.
* Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features.
* Metastatic prostate cancer documented by positive bone scan (for bone disease) or metastatic lesion(s) on CT or MRI (for soft tissue/visceral disease).
* Resolution of acute effects of any prior therapy to either baseline severity or CTCAE Grade ≤1 (except for AEs which do not constitute a safety risk in the investigator's judgement).
* Participants must have ECOG PS 0 or 1.
Exclusion Criteria
* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Clinically significant cardiovascular disease.
* Known or suspected brain metastasis or active leptomeningeal disease.
* Participants must be treatment naïve at the mCSPC stage, eg, participants cannot have received any cytotoxic chemotherapy with the following exceptions: Treatment with first-generation antiandrogen (ADT) agents is allowed for mCSPC.
* Previous administration with an investigational product (drug or vaccine) within 30 days.
* Use of 5-alpha reductase inhibitors is prohibited within 28 days of randomization.
* Prior surgery from which the participant has not fully recovered at least 28 days prior to randomization
* Current use or anticipated need for drugs that are known strong CYP3A4/5 inhibitors and inducers (with exception of enzalutamide as part of this study).
* Inadequate organ function.
* Known allergic or hypersensitivity reactions to mevrometostat or its excipients or to enzalutamide or its excipients.
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