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.

Clinicaltrials.gov ID: NCT07028853
db-list-check Status RECRUITING
b-loader Phase PHASE3
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 1000

Conditions

Metastatic Castration Sensitive Prostate Cancer (mCSPC), Hormone Sensitive Prostate Cancer, Prostate Cancer, Cancer of the Prostate

Drugs

Mevrometostat, Placebo, Enzalutamide

Summary

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.

Detailed Description

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.

Locations

17 locations Found with status Recruiting

Status

  • RECRUITING

Central Contacts

Study Director

  • Pfizer CT.gov Call Center

Status

  • RECRUITING

Central Contacts

Study Director

  • Pfizer CT.gov Call Center

Status

  • RECRUITING

Central Contacts

Study Director

  • Pfizer CT.gov Call Center

Status

  • RECRUITING

Central Contacts

Study Director

  • Pfizer CT.gov Call Center

Status

  • RECRUITING

Central Contacts

Study Director

  • Pfizer CT.gov Call Center

Status

  • RECRUITING

Central Contacts

Study Director

  • Pfizer CT.gov Call Center

Status

  • RECRUITING

Central Contacts

Study Director

  • Pfizer CT.gov Call Center

Status

  • RECRUITING

Central Contacts

Study Director

  • Pfizer CT.gov Call Center

Status

  • RECRUITING

Central Contacts

Study Director

  • Pfizer CT.gov Call Center

Status

  • RECRUITING

Central Contacts

Study Director

  • Pfizer CT.gov Call Center

Status

  • RECRUITING

Central Contacts

Study Director

  • Pfizer CT.gov Call Center

Status

  • RECRUITING

Central Contacts

Study Director

  • Pfizer CT.gov Call Center

Status

  • RECRUITING

Central Contacts

Study Director

  • Pfizer CT.gov Call Center

Status

  • RECRUITING

Central Contacts

Study Director

  • Pfizer CT.gov Call Center

Status

  • RECRUITING

Central Contacts

Study Director

  • Pfizer CT.gov Call Center

Status

  • RECRUITING

Central Contacts

Study Director

  • Pfizer CT.gov Call Center

Status

  • RECRUITING

Central Contacts

Study Director

  • Pfizer CT.gov Call Center

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 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.
* 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.

Study Plan

Arm A

EXPERIMENTAL

Participants will receive mevrometostat/PF-06821497 (875 mg) BID (twice daily) + enzalutamide 160 mg QD (once daily)

  • DRUG:

    Mevrometostat

    Description:

    Oral continuous
  • DRUG:

    Enzalutamide

    Description:

    Oral continuous

Arm B

ACTIVE_COMPARATOR

Participants will receive Placebo BID (twice daily) + enzalutamide 160 mg QD (once daily)

  • DRUG:

    Placebo

    Description:

    Oral continuous
  • DRUG:

    Enzalutamide

    Description:

    Oral continuous

Outcome Measures

Primary Outcome Measures

Radiographic Progression Free Survival (rPFS)

Time Frame: Randomization up to approximately 4 years

Secondary Outcome Measures

Overall survival (OS)

Time Frame: Randomization up to approximately 9 years

Objective response in measurable soft tissue disease

Time Frame: Randomization up to approximately 4 years

Duration of Response (DoR) in measurable soft tissue disease

Time Frame: Randomization up to approximately 4 years

Prostate Specific Antigen Response

Time Frame: Randomization up to approximately 4 years

Time to prostate specific antigen (PSA) progression

Time Frame: Randomization up to approximately 4 years

Time to initiation of antineoplastic therapy

Time Frame: Randomization up to approximately 4 years

Time to first symptomatic skeletal event

Time Frame: Randomization up to approximately 4 years

Time from randomization to CRPC

Time Frame: Randomization up to approximately 4 years

Incidence of Adverse Events

Time Frame: Randomization up to approximately 5 years

To evaluate the PK of mevrometostat when dosed in combination with enzalutamide

Time Frame: Cycle 3 Day 1 to last PK draw at Cycle 5 Day 1 (cycle length is 28 days)

Change from baseline in patient reported pain symptoms per Brief Pain Inventory-Short Form (BPI-SF)

Time Frame: Randomization up to approximately 5 years

Change from baseline in health-related quality of life (HRQoL) per Functional Assessment of Cancer Therapy - Prostate (FACT-P)

Time Frame: Randomization up to approximately 5 years

Time to definitive deterioration in patient-reported health related quality of life (HRQoL) per FACT-P

Time Frame: Randomization up to approximately 5 years

Patient-reported outcomes in cancer specific symptoms - time to definitive deterioration

Time Frame: Randomization up to approximately 5 years

Change from baseline and time to confirmed deterioration in participant-reported fatigue symptoms per BFI

Time Frame: Randomization up to approximately 5 years

Change from baseline in participant-reported general health status per EQ-5D-5L

Time Frame: Randomization up to approximately 5 years

To assess circulating tumor DNA (ctDNA) at baseline and on treatment to evaluate tumor burden

Time Frame: Baseline up to approximately 4 years

Timeline

  • Last Updated
    November 12, 2025
  • Start Date
    June 19, 2025
  • Today
    January 2, 2026
  • Completion Date ( Estimated )
    December 8, 2034

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