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.
NCT ID: NCT07028853
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1000 participants
INTERVENTIONAL
2025-09-28
2034-12-08
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Participants and their caregivers will be blinded to their assigned study intervention.
Investigators and other site staff will be blinded to participants' assigned study intervention Sponsor staff will be blinded to participants' assigned study intervention, except for sponsor staff involved in the assignment or distribution of study intervention.
Study Groups
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Arm A
Participants will receive mevrometostat/PF-06821497 (875 mg) BID (twice daily) + enzalutamide 160 mg QD (once daily)
Mevrometostat
Oral continuous
Enzalutamide
Oral continuous
Arm B
Participants will receive Placebo BID (twice daily) + enzalutamide 160 mg QD (once daily)
Placebo
Oral continuous
Enzalutamide
Oral continuous
Interventions
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Mevrometostat
Oral continuous
Placebo
Oral continuous
Enzalutamide
Oral continuous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
MALE
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Ironwood Cancer & Research Centers
Chandler, Arizona, United States
Ironwood Cancer & Research Centers
Gilbert, Arizona, United States
Ironwood Cancer & Research Centers
Glendale, Arizona, United States
Ironwood Cancer & Research Centers
Goodyear, Arizona, United States
Ironwood Cancer & Research Centers
Mesa, Arizona, United States
Ironwood Cancer & Research Centers
Mesa, Arizona, United States
Ironwood Cancer & Research Centers
Phoenix, Arizona, United States
Ironwood Cancer & Research Centers
Scottsdale, Arizona, United States
Highlands Oncology Group, PA
Fayetteville, Arkansas, United States
Highlands Oncology Group, PA
Rogers, Arkansas, United States
Highlands Oncology Group, PA
Springdale, Arkansas, United States
Cancer Care Specialists of Illinois
Decatur, Illinois, United States
Cancer Care Specialists of Illinois
O'Fallon, Illinois, United States
Montefiore Einstein Comprehensive Cancer Center
The Bronx, New York, United States
Montefiore Medical Center- Montefiore Medical Park
The Bronx, New York, United States
TriState Urologic Services PSC Inc. dba The Urology Group
Cincinnati, Ohio, United States
The Centers for Advanced Urology, LLP d/b/a Keystone Urology Specialists
Lancaster, Pennsylvania, United States
Grand Strand Medical Center
Myrtle Beach, South Carolina, United States
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, United States
Parkway Surgery Center
Myrtle Beach, South Carolina, United States
Urology Associates, P.C.
Nashville, Tennessee, United States
US Oncology Investigational Product Center (IPC)
Irving, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Blue Ridge Cancer Care
Blacksburg, Virginia, United States
Blue Ridge Cancer Care
Low Moor, Virginia, United States
Blue Ridge Cancer Care
Roanoke, Virginia, United States
Blue Ridge Cancer Care
Salem, Virginia, United States
Blue Ridge Cancer Care
Wytheville, Virginia, United States
Northwest Medical Specialties, PLLC
Bonney Lake, Washington, United States
Northwest Medical Specialties, PLLC
Federal Way, Washington, United States
Northwest Medical Specialties, PLLC
Gig Harbor, Washington, United States
Northwest Medical Specialties, PLLC
Puyallup, Washington, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States
ICON Cancer Centre - Kurralta Park
Kurralta Park, South Australia, Australia
Diex Recherche Trois-Rivieres
Trois-Rivières, Quebec, Canada
Wannan Medical College Yijishan Hospital
Wuhu, Anhui, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital Affiliate of Capital University
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Lanzhou university second hospital
Lanzhou, Gansu, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
First Huai'an Hospital Affiliated to Nanjing Medical University
Huai'an, Jiangsu, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Nantong Tumor Hospital
Nantong, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Shandong Provincial Hospital
Jinan, Shandong, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Suining Central Hospital
Suining, Sichuan, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The first affiliated hospital of Ningbo university
Ningbo, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
The Third Affiliated Hospital of Southern Medical University
Guangzhou, , China
Rabin Medical Center
Petah Tikva, Central District, Israel
Shaare Zedek Medical Center
Jerusalem, Jerusalem, Israel
Chiba cancer center
Chiba, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
Yokosuka Kyosai Hospital
Yokosuka, Kanagawa, Japan
The University of Osaka Hospital
Suita, Osaka, Japan
Keio university hospital
Shinjuku-ku, Tokyo, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, , Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, , Japan
Osaka International Cancer Institute
Osaka, , Japan
Yamagata University Hospital
Yamagata, , Japan
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Ewha Womans University Mokdong Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Kyungpook National University Chilgok Hospital
Deagu, Taegu-kwangyǒkshi, South Korea
Chungnam national university hospital
Junggu, Taejǒn-kwangyǒkshi, South Korea
Taichung Veterans General Hospital
Taichung, , Taiwan
Countries
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Central Contacts
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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MEVPRO-3
Identifier Type: OTHER
Identifier Source: secondary_id
2024-519369-24-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
C2321008
Identifier Type: -
Identifier Source: org_study_id