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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.

NCT07028853

RecruitingPhase 3

Sponsor: Pfizer

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

Interventions: Mevrometostat, Placebo, Enzalutamide

Countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China

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.

Eligibility overview

Sex: MALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
* 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.

Locations (341)

Huntsville, Alabama, United States
Huntsville, Alabama, United States
Chandler, Arizona, United States
Gilbert, Arizona, United States
Glendale, Arizona, United States
Goodyear, Arizona, United States
Mesa, Arizona, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Fayetteville, Arkansas, United States
Rogers, Arkansas, United States
Springdale, Arkansas, United States
Alhambra, California, United States
Atascadero, California, United States
Beverly Hills, California, United States
Beverly Hills, California, United States
Beverly Hills, California, United States
Burbank, California, United States
Encino, California, United States
Irvine, California, United States
Laguna Hills, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Marina del Rey, California, United States
Pasadena, California, United States
Porter Ranch, California, United States
San Luis Obispo, California, United States
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