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

May 11, 2026 updated by: Prostate Cancer Clinical Trials Consortium

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)
  • 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

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 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)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
875 mg oral tablet, taken twice daily with food
Other Names:
  • PF-06821497
Drug: Enzalutamide
160 mg oral capsule, taken once daily
Other Names:
  • Xtandi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From start of study treatment until death from any cause, assessed up to 24 months.
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.
From start of study treatment until death from any cause, assessed up to 24 months.
Proportion of Participants Achieving 50% Decline in PSA (PSA50 Response)
Time Frame: From initiation of study treatment through study completion, assessed up to 24 months.
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.
From initiation of study treatment through study completion, assessed up to 24 months.
Time to PSA Progression as Defined by PCWG3
Time Frame: From start of study treatment until documented PSA progression, assessed up to 24 months.
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.
From start of study treatment until documented PSA progression, assessed up to 24 months.
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time Frame: From start of study treatment through 28 days after last dose of study drug, assessed up to 24 months.
Incidence of adverse events characterized by type, severity according to CTCAE version 5.0, timing, seriousness, and relationship to study treatment.
From start of study treatment through 28 days after last dose of study drug, assessed up to 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prostate Cancer Clinical Trials Consortium

Collaborators

Pfizer
Dana-Farber Cancer Institute
Fred Hutchinson Cancer Center

Investigators

  • Principal Investigator: Atish Choudhury, MD, PhD, Dana-Farber Cancer Institute
  • Principal Investigator: Michael Schweizer, MD, University of Washington- Fred Hutch Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

August 1, 2029

Study Registration Dates

First Submitted

May 4, 2026

First Submitted That Met QC Criteria

May 11, 2026

First Posted (Actual)

May 18, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • c25-392

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Supporting Information Type

  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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