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Looking for participantsPhase3

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.

Sponsor: Pfizer

NCT ID: NCT07028853

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Mevrometostat (drug), Placebo (drug), Enzalutamide (drug)
How long the study runs
Study runs about 111 months (dates as stated)
About the drug or intervention
Mevrometostat — drug: Oral continuous · Placebo — drug: Oral continuous · Enzalutamide — drug: Oral continuous
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
Male
Number of participants
1,000
Started
2025-09-28
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for metastatic castration sensitive prostate cancer (mcspc)
  • • Phase3 - 1,000 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with metastatic castration sensitive prostate cancer (mcspc)
  • • Male only

Where?

  • • Blackburn - Royal Blackburn Hospital
  • • Cardiff - Velindre Cancer Centre
  • • Plymouth - Derriford Hospital
  • • Torquay - Torbay Hospital
  • • +4 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

This is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study evaluating mevrometostat in combination with enzalutamide versus placebo in combination with enzalutamide in participants with mCSPC who have not received systemic anticancer treatments with the exception of androgen-deprivation therapy (ADT) and first-generation antiandrogen agents. Prior therapy with up to 3 months of ADT (chemical or surgical) is allowed, with no radiographic evidence of disease progression or rising PSA levels prior to Day 1. This study consists of a Screening Phase, Randomization, Treatment Phase, Safety Follow-up, and Long-Term Follow-up. Participants will be randomized on a 1:1 basis to receive (Arm A) mevrometostat (PF-06821497) in combination with enzalutamide, or (Arm B) placebo in combination with enzalutamide.

Metastatic Castration Sensitive Prostate Cancer (mCSPC)Hormone Sensitive Prostate CancerProstate CancerCancer of the Prostate

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Gender· Tell us your sex for better matching

Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: Male only

Biomarkers mentioned

documented by positive

Treatment history

Treatments you must have had:

  • ✓ to either baseline severity
  • ✓ ECOG PS 0 or 1

What the study is looking for

  • ✓Inclusion Criteria
  • ✓Male participants aged ≥18 years (or the minimum age of consent in accordance with local regulations) at screening.
  • ✓confirmed by testing a sample adenocarcinoma of the prostate without small cell features.
  • ✓that has spread prostate cancer documented by positive bone scan (for bone disease) or that has spread lesion(s) on CT or MRI...
  • ✓Resolution of acute effects of any prior therapy to either baseline severity or CTCAE Grade ≤1 (except for AEs which...
See the full 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 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.

Where Is This Study? (8 UK sites)

Royal Blackburn Hospital

Blackburn BB2 3HH, United Kingdom

ACTIVE_NOT_RECRUITING

Velindre Cancer Centre

Cardiff CF14 2TL, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Sarah Townsend

Velindre.R&Doffice@wales.nhs.uk02920 196165

Derriford Hospital

Plymouth Pl6 8DH, United Kingdom

ACTIVE_NOT_RECRUITING

Torbay Hospital

Torquay TQ2 7AA, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Dr Fiona Roberts (R&D Director)

tsdft.research@nhs.net01803 656635

Imperial College Healthcare NHS Trust, Charing Cross Hospital

London W6 8RF, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Donna Copeland

donna.copeland@nhs.net---

Royal Marsden Hospital (Chelsea)

London SW3 6JJ, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

Maidstone Hospital

Maidstone ME16 9QQ, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Denise Day / Julie Knowles

mtw-tr.researchgovernance@nhs.net01622 225627

The Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

How to Get in Touch

Pfizer CT.gov Call Center

Sponsor contact

CONTACT

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09