Recruiting

Phase 3

Mevrometostat & EnzalutamideThis 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

Code:

NCT07028853

Conditions

Metastatic Castration Sensitive Prostate Cancer (mCSPC)

Hormone Sensitive Prostate Cancer

Prostate Cancer

Cancer of the Prostate

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mevrometostat

Placebo

Enzalutamide

Study Details

Brief 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.

Conditions

Metastatic Castration Sensitive Prostate Cancer (mCSPC)

Hormone Sensitive Prostate Cancer

Prostate Cancer

Cancer of the Prostate

Study ID

NCT07028853

Start date

Sep 28, 2025

Status verified date

Aug, 2026

Completion date

Dec 8, 2034

Anticipated

Primary completion date

Sep 12, 2028

Anticipated

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A

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

active comparator: Arm B

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

Interventions

Mevrometostat

Oral continuous

Placebo

Oral continuous

Enzalutamide

Oral continuous

Primary outcome measure

Radiographic Progression Free Survival (rPFS) [ Time Frame: Randomization up to approximately 4 years ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations

Clearview Cancer Institute (Crestwood)

Recruiting

Huntsville, Alabama, United States, 35801

Clearview Cancer Institute

Recruiting

Huntsville, Alabama, United States, 35805