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.

What this study is about

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 join (things the study team will check)

✅ You may be able to join if…

• 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.

🚫 You may not be able to join if…

• 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 this trial is running

• Clearview Cancer Institute (Crestwood), Huntsville, Alabama, United States
• Clearview Cancer Institute, Huntsville, Alabama, United States
• Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers, Chandler, Arizona, United States
• Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers, Gilbert, Arizona, United States
• Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers, Glendale, Arizona, United States
• Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers, Goodyear, Arizona, United States
• Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers, Mesa, Arizona, United States
• Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers, Mesa, Arizona, United States
• Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers, Phoenix, Arizona, United States
• Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers, Scottsdale, Arizona, United States
• Highlands Oncology Group, PA, Fayetteville, Arkansas, United States
• Highlands Oncology Group, PA, Rogers, Arkansas, United States

+ 329 more sites.

Who to contact

Pfizer CT.gov Call Center · 1-800-718-1021 · ClinicalTrials.gov_Inquiries@pfizer.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07028853.