A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Mevrometostat (PF-06821497) With Enzalutamide in Metastatic Castration-Sensitive Prostate Cancer (MEVPRO-3)
Status: Recruiting
Location: See all (38) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arkansas
Highlands Oncology Group, PA
RECRUITING
Fayetteville
Highlands Oncology Group, PA
RECRUITING
Rogers
Highlands Oncology Group, PA
RECRUITING
Springdale
Arizona
Arizona Urology Specialists, PLLC
NOT_YET_RECRUITING
Tucson
Illinois
Cancer Care Specialists of Illinois
NOT_YET_RECRUITING
Decatur
Cancer Care Specialists of Illinois
NOT_YET_RECRUITING
O'fallon
Pennsylvania
The Centers for Advanced Urology, LLP d/b/a Keystone Urology Specialists
NOT_YET_RECRUITING
Lancaster
Utah
Huntsman Cancer Institute
NOT_YET_RECRUITING
Salt Lake City
Other Locations
Canada
Diex Recherche Trois-Rivieres
RECRUITING
Trois-rivières
China
Beijing Friendship Hospital Affiliate of Capital University
NOT_YET_RECRUITING
Beijing
Hunan Cancer Hospital
NOT_YET_RECRUITING
Changsha
Chongqing University Cancer Hospital
NOT_YET_RECRUITING
Chongqing
The Third Affiliated Hospital of Southern Medical University
NOT_YET_RECRUITING
Guangzhou
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
Zhejiang Provincial People's Hospital
NOT_YET_RECRUITING
Hangzhou
First Huai'an Hospital Affiliated to Nanjing Medical University
NOT_YET_RECRUITING
Huai'an
Qilu Hospital of Shandong University
NOT_YET_RECRUITING
Jinan
Shandong Provincial Hospital
NOT_YET_RECRUITING
Jinan
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
NOT_YET_RECRUITING
Nanjing
Nantong Tumor Hospital
NOT_YET_RECRUITING
Nantong
The first affiliated hospital of Ningbo university
NOT_YET_RECRUITING
Ningbo
Fudan University Shanghai Cancer Center
NOT_YET_RECRUITING
Shanghai
The Second Affiliated Hospital of Soochow University
NOT_YET_RECRUITING
Suzhou
The First Affiliated Hospital of Wenzhou Medical University
NOT_YET_RECRUITING
Wenzhou
Wannan Medical College Yijishan Hospital
NOT_YET_RECRUITING
Wuhu
The First Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi'an
Japan
Chiba cancer center
NOT_YET_RECRUITING
Chiba
National Hospital Organization Kyushu Cancer Center
NOT_YET_RECRUITING
Fukuoka
Kanazawa University Hospital
NOT_YET_RECRUITING
Kanazawa
Kobe University Hospital
NOT_YET_RECRUITING
Kobe
National Hospital Organization Kumamoto Medical Center
NOT_YET_RECRUITING
Kumamoto
National Hospital Organization Shikoku Cancer Center
NOT_YET_RECRUITING
Matsuyama
Hokkaido University Hospital
NOT_YET_RECRUITING
Sapporo
National Hospital Organization Hokkaido Cancer Center
NOT_YET_RECRUITING
Sapporo
Keio university hospital
NOT_YET_RECRUITING
Shinjuku-ku
The University of Osaka Hospital
NOT_YET_RECRUITING
Suita
Yamagata University Hospital
NOT_YET_RECRUITING
Yamagata
Yokosuka Kyosai Hospital
NOT_YET_RECRUITING
Yokosuka
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2025-09-28
Estimated Completion Date: 2034-12-08
Participants
Target number of participants: 1000
Treatments
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)
Related Therapeutic Areas
Sponsors
Leads: Pfizer