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Metastatic Castrate Resistant Prostate Cancer (mCRPC)Phase 2MOMENTNCT07592910

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

A Phase 2 study testing Mevrometostat and Enzalutamide in people with Metastatic Castrate Resistant Prostate Cancer (mCRPC) and Prostate Cancer (Adenocarcinoma), run by Prostate Cancer Clinical Trials Consortium.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Mevrometostat and Enzalutamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
Aug 2026to Aug 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing and able to provide written informed consent
  • 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 (metastatic disease), confirmed by imaging
  • ECOG performance status of 0, 1, or 2 (able to care for self and up and about more than 50% of waking hours)
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  • 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 birth control during the study and for 30 days after the last dose

Who cannot join

  • 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 transient ischemic attack within 12 months
  • Untreated brain metastases, spinal cord compression, or clinically significant 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 hepatitis B or C (well-controlled HIV is allowed)
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  • Known history of chronic liver disease (e.g., alcoholic liver disease, primary biliary cirrhosis, autoimmune 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 NYHA Class III/IV, pulmonary embolism, significant arrhythmias), cardiac pacemaker, or QTcF greater than 480 msec on screening ECG
  • 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 investigational 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 CYP3A4/5 inhibitors or inducers (other than enzalutamide) within 10 days or 5 half-lives prior to treatment start

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Sarah Wise contact

215-380-9051

wises@mskcc.org

About this study

Official title: A Phase 2, Open-label, Single-Arm Study of Mevrometostat Plus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer Following Prior Androgen Receptor Pathway Inhibitor Therapy (MOMENT)

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.

Being tested
Mevrometostat, Enzalutamide
Keywords
Mevrometostat, EZH2 inhibitor, Enzalutamide, ARPI resistance, MOMENT, mCRPC, Prostate Cancer
Medical subject headings
Prostatic Neoplasms, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MevrometostatDrug

    Also called PF-06821497

    875 mg oral tablet, taken twice daily with food

  • EnzalutamideDrug

    Also called Xtandi

    160 mg oral capsule, taken once daily

Study groups in NCT07592910
Study groupRoleWhat they receive
Mevrometostat + EnzalutamideExperimentalMevrometostat 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.
Receives: Drug: Mevrometostat; Drug: Enzalutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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 (4)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2026
  2. Study startAug 2026 (estimated)
  3. Primary completionMay 2029 (estimated)
  4. Study completionAug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07592910
Sponsor's protocol ID
c25-392
Acronym
MOMENT
Status last verified
May 2026
First submitted
4 May 2026
Last updated
18 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mevrometostat and Enzalutamide in people with Metastatic Castrate Resistant Prostate Cancer (mCRPC) and Prostate Cancer (Adenocarcinoma), run by Prostate Cancer Clinical Trials Consortium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sarah Wise (215-380-9051, wises@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiographic progression free survival (rPFS) (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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07592910.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.

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