ClinicalTrials.gg
Not yet recruitingNCT07592910MOMENTUpdated May 18, 2026

A Study of Mevrometostat With Enzalutamide in People With Prostate Cancer Who Have Previously Received Androgen Receptor Pathway Inhibitor Therapy

A Phase 2 interventional study of Mevrometostat and Enzalutamide in Metastatic Castrate Resistant Prostate Cancer (mCRPC) and Prostate Cancer (Adenocarcinoma), sponsored by Prostate Cancer Clinical Trials Consortium. Not yet recruiting. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-18.

Sponsored by Prostate Cancer Clinical Trials Consortium · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study summary

The purpose of this study is to find out whether mevrometostat in combination with enzalutamide delays cancer progression in people with metastatic castration-resistant prostate cancer (mCRPC) who have previously received enzalutamide, darolutamide, or apalutamide in the metastatic castration-sensitive prostate cancer (mCSPC) or non-metastatic castration-resistant prostate cancer (nmCRPC) setting but have not previously progressed on abiraterone.

02

Conditions studied

  • Metastatic Castrate Resistant Prostate Cancer (mCRPC)
  • Prostate Cancer (Adenocarcinoma)

Keywords

  • Mevrometostat
  • EZH2 inhibitor
  • Enzalutamide
  • ARPI resistance
  • MOMENT
  • mCRPC
  • Prostate Cancer
03

In context

Prostatic Neoplasms

7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Prostate Cancer Clinical Trials Consortium is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Willing and able to provide written
  • Age 18 years or older
  • Diagnosis of prostate cancer (adenocarcinoma) confirmed by tissue sample, without neuroendocrine or small cell features
  • Currently taking or recently treated with enzalutamide, darolutamide, or apalutamide (within 30 days of screening) and willing to switch to or restart enzalutamide for this study
  • Cancer has spread to bone or soft tissue ( disease), confirmed by imaging
  • performance status of 0, 1, or 2 (able to care for self and up and about more than 50% of waking hours)
  • Testosterone level less than 50 ng/dL at screening, with ongoing hormone deprivation therapy or prior surgical castration
  • If receiving bone-protective therapy (e.g., denosumab or bisphosphonates), must be on a stable dose for at least 4 weeks
  • Evidence of cancer progression while on enzalutamide, darolutamide, or apalutamide, shown by rising PSA, worsening disease on imaging, or new bone lesions
  • Adequate organ function based on blood tests within 28 days of starting treatment, including adequate blood counts, kidney function, and liver function
  • Willing to use acceptable during the study and for 30 days after the last dose

Exclusion criteria

Exclusion Criteria:

  • History of myelodysplastic syndrome, acute myeloid leukemia, or other prior cancer (exceptions: non-melanoma skin cancer, carcinoma in situ, cancers more than 3 years ago with no recurrence, or early-stage cancers with low risk of recurrence)
  • Any medical or psychiatric condition, including active infection or recent suicidal ideation, that may make study participation unsafe
  • History of seizure or conditions that may increase seizure risk (e.g., prior stroke, significant brain trauma), or loss of consciousness or within 12 months
  • Untreated , spinal cord compression, or epidural disease
  • Use of 5-alpha reductase inhibitors, herbal medications, or supplements known to alter PSA levels within 4 weeks of starting treatment
  • AIDS-related illness or active or C (well-controlled is allowed)
  • Known history of chronic liver disease (e.g., alcoholic liver disease, primary biliary cirrhosis, hepatitis, Wilson's disease, hemochromatosis)
  • Known history of active inflammatory gastrointestinal disease, chronic diarrhea, or prior gastric resection or lap-band surgery
  • Clinically significant cardiovascular disease within the past 6 months (e.g., heart attack, unstable angina, stroke, heart failure Class III/IV, pulmonary embolism, significant arrhythmias), cardiac pacemaker, or greater than 480 msec on screening
  • Prior or current use of PARP inhibitors and/or AKT inhibitors
  • Prior cancer progression on abiraterone (stopping abiraterone due to side effects is allowed)
  • Known allergy to any study drug
  • Blood transfusion within 28 days prior to screening blood tests
  • Use of another drug within 4 weeks before starting study treatment
  • Any other condition that, in the opinion of the investigator, would prevent safe participation
  • Current use or anticipated need for strong /5 inhibitors or inducers (other than enzalutamide) within 10 days or 5 half-lives prior to treatment start
Terms in these criteria, in plain language(15)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Mevrometostat + Enzalutamide

    Mevrometostat 875 mg orally twice daily (BID) with food in combination with enzalutamide 160 mg orally once daily. Treatment continues until confirmed radiographic disease progression, unacceptable toxicity, or other protocol-defined discontinuation criteria.

    Drug: Mevrometostat · Drug: Enzalutamide

Interventions

  • 875 mg oral tablet, taken twice daily with food

    Also known as: PF-06821497

  • 160 mg oral capsule, taken once daily

    Also known as: Xtandi

06

What researchers measure

Primary outcomes

  1. Radiographic progression free survival (rPFS)

    rPFS by RECIST v1.1 and PCWG3 defined as time from start of study treatment to the earlier of first documentation of objective progressive disease by RECIST v1.1 or PCWG3 or death due to any cause.

    Time frame: From treatment initiation until documented disease progression, death, lost to follow-up, withdrawal, administrative censoring at the time of final analysis, whichever comes first, assessed up to 24 months.

Secondary outcomes

  1. Overall Survival (OS)

    Overall survival as determined by survival status during study participation. OS is defined as the time from the start of study treatment to the date of death due to any cause.

    Time frame: From start of study treatment until death from any cause, assessed up to 24 months.

  2. Proportion of Participants Achieving 50% Decline in PSA (PSA50 Response)

    Proportion of participants with detectable PSA values at baseline with a 50% decline in PSA confirmed by a subsequent PSA value obtained ≥3 weeks later.

    Time frame: From initiation of study treatment through study completion, assessed up to 24 months.

  3. Time to PSA Progression as Defined by PCWG3

    Time from first dose of mevrometostat to the date of a ≥25% increase in PSA over nadir with an absolute increase of ≥2 ng/mL, confirmed by a second consecutive PSA value at ≥3 weeks later.

    Time frame: From start of study treatment until documented PSA progression, assessed up to 24 months.

  4. Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0

    Incidence of adverse events characterized by type, severity according to CTCAE version 5.0, timing, seriousness, and relationship to study treatment.

    Time frame: From start of study treatment through 28 days after last dose of study drug, assessed up to 24 months.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — The Prostate Cancer Clinical Trials Consortium, LLC supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: pcctc@mskcc.org.

Supporting information: Informed consent form

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07592910
Lead sponsor
Prostate Cancer Clinical Trials Consortium
Responsible party
Sponsor
First posted
May 18, 2026
Start date
Aug 2026 (estimated)
Primary completion
May 2029 (estimated)
Completion
Aug 2029 (estimated)
Last update
May 18, 2026

Study contacts

Sarah Wise
Contact
wises@mskcc.org
215-380-9051
Michael Schweizer, MD
principal investigator · University of Washington- Fred Hutch Cancer Center
Atish Choudhury, MD, PhD
principal investigator · Dana-Farber Cancer Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Mevrometostat

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