A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.

Last updated: April 14, 2025
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

3

Condition

Prostate Cancer

Prostate Disorders

Prostate Cancer, Early, Recurrent

Treatment

PF-06821497

Placebo

Enzalutamide

Clinical Study ID

NCT06629779
C2321003
2024-511652-40-00
  • Ages > 18
  • Male

Study Summary

This study will explore whether a combination of the investigational drug PF-06821497 and enzalutamide will work better than taking enzalutamide alone in participants with mCRPC who are ARSi or abiraterone naïve.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male participants aged ≥18 years (or the minimum age of consent in accordance withlocal regulations) at screening.

  • Histologically or cytologically confirmed adenocarcinoma of the prostate withoutsmall cell features.

  • Metastatic disease in bone documented on bone scan, or in soft tissue documented onCT/MRI scan.

  • Surgically or medically castrated, with serum testosterone ≤50 ng/dL (≤1.73 nmol/L)at screening.

  • Metastatic disease in bone documented on bone scan, or in soft tissue documented onCT/MRI scan.

  • Progressive disease in the setting of medical or surgical castration.

  • Prior to randomization, there must be resolution of acute effects of any priortherapy to either baseline severity or CTCAE Grade ≤1.

  • ECOG performance status 0 or 1, with a life expectancy of ≥12 months as assessed bythe investigator.

Exclusion

Exclusion Criteria:

  • Any medical or psychiatric condition including recent (within the past year) oractive suicidal ideation/behavior or laboratory abnormality that may increase therisk of study participation or, in the investigator's judgment, make the participantinappropriate for the study.

  • Clinically significant cardiovascular disease.

  • Known or suspected brain metastasis or active leptomeningeal disease.

  • Participants must be treatment naïve at the mCRPC stage, eg, participants cannothave received any cytotoxic chemotherapy with the following exceptions: Treatmentwith first-generation antiandrogen (ADT) agents and. Docetaxel treatment is allowedfor mCSPC.

  • Previous administration with an investigational product (drug or vaccine) within 30days.

  • Current use or anticipated need for drugs that are known strong CYP3A4/5 inhibitorsand inducers (with exception of enzalutamide as part of this study).

  • Major surgery or palliative localized radiation therapy within 14 days beforerandomization.

  • Inadequate organ function.

Study Design

Total Participants: 900
Treatment Group(s): 3
Primary Treatment: PF-06821497
Phase: 3
Study Start date:
October 22, 2024
Estimated Completion Date:
November 30, 2028

Study Description

This is a global, multicenter, randomized Phase 3 study evaluating PF-06821497 (mevrometostat) in combination with enzalutamide versus placebo in combination with enzalutamide in participants with mCRPC where no systemic anti-cancer treatments have been initiated after documentation of mCRPC with the exception of ADT (androgen deprivation therapy) and first-generation anti-androgen agents. Prior treatment with any of the ARSi's enzalutamide, darolutamide, apalutamide, or abiraterone acetate, is not permitted in any setting. Chemotherapy is permitted in the castrate sensitive setting.

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) PF-06821497 in combination with enzalutamide, or (Arm B) placebo in combination with enzalutamide.

Connect with a study center

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    Caba, Buenos Aires C1120AAT
    Argentina

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  • Hospital Sirio Libanes

    Capital Federal, Buenos Aires C1419AHN
    Argentina

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  • Centro Medico Privado CEMAIC

    Capital, Córdoba X5008HHW
    Argentina

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  • Hospital Privado Universitario de Córdoba

    Cordoba, Córdoba 5016
    Argentina

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  • Asociación de Beneficencia Hospital Sirio Libanés

    Buenos Aires, C1419AHN
    Argentina

    Active - Recruiting

  • Centro Medico Fleischer

    Buenos Aires,
    Argentina

    Active - Recruiting

  • IMAXE

    Buenos Aires, C1120
    Argentina

    Active - Recruiting

  • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

    Santo André, SÃO Paulo 09060-650
    Brazil

    Site Not Available

  • Multiprofile Hospital for Active Treatment Dr. Tota Venkova AD

    Gabrovo, 5300
    Bulgaria

    Site Not Available

  • "University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski" EAD

    Pleven, 5800
    Bulgaria

    Site Not Available

  • Complex Oncology Center - Plovdiv EOOD

    Plovdiv, 4004
    Bulgaria

    Active - Recruiting

  • Complex Oncology Center Stara Zagora EOOD

    Stara Zagora, 6003
    Bulgaria

    Site Not Available

  • Cross Cancer Institute

    Edmonton, Alberta T6G 1Z2
    Canada

    Site Not Available

  • Wannan Medical College Yijishan Hospital

    Wuhu, Anhui 241001
    China

    Active - Recruiting

  • Cancer Hospital Chinese Academy of Medical Science

    Beijing, Beijing 100021
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fuzhou, Fujian 350014
    China

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  • Guangzhou First People's Hospital

    Guangzhou, Guangdong 510180
    China

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  • The Second Affiliated Hospital of Shantou University School of Medicine

    Shantou, Guangdong 515000
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi 541199
    China

    Site Not Available

  • The Third Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan 453003
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, Henan 450008
    China

    Site Not Available

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei 430022
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  • Hunan Cancer Hospital

    Changsha, Hunan 410013
    China

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  • Inner Mongolia People's Hospital

    Hohhot, Inner Mongolia 010017
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    Huai'an, Jiangsu 223300
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  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu 210000
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  • Nantong Tumor Hospital

    Nantong, Jiangsu 226361
    China

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  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215004
    China

    Site Not Available

  • Shaanxi Provincial People' Hospital

    Xi'an, Shaanxi 710068
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi 710061
    China

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  • Shandong Provincial Hospital

    Jinan, Shandong 250021
    China

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    Qingdao, Shandong 266003
    China

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  • Weifang People's Hospital

    Weifang, Shandong 261041
    China

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  • Yantai Yuhuangding Hospital

    Yantai, Shandong 264099
    China

    Site Not Available

  • Tongji Hospital of Tongji University

    Shanghai, Shanghai 200065
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Cheng Du, Sichuan 610041
    China

    Active - Recruiting

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou City, Zhejiang 310016
    China

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  • The first affiliated hospital of Ningbo university

    Ningbo, Zhejiang 315010
    China

    Active - Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang 325000
    China

    Active - Recruiting

  • The First Hospital of Jiaxing

    Jiaxing, Zhejiang/nanhu 314001
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  • Peking University Third Hospital

    Beijing, 100191
    China

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  • First Affiliated Hospital of China Medical University

    Shenyang, 110001
    China

    Site Not Available

  • Fakultni nemocnice Olomouc

    Olomouc, Olomoucký KRAJ 779 00
    Czechia

    Site Not Available

  • Multiscan

    Pardubice, Pardubický KRAJ 53203
    Czechia

    Site Not Available

  • Fakultni nemocnice Kralovske Vinohrady

    PRague, Praha 10 10034
    Czechia

    Site Not Available

  • Urocentrum Praha

    Prague, Praha 2 120 00
    Czechia

    Active - Recruiting

  • Fakultni Thomayerova nemocnice

    Prague, Praha 4 14059
    Czechia

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  • Vejle Sygehus

    Vejle, Syddanmark 7100
    Denmark

    Site Not Available

  • Tampereen yliopistollinen sairaala

    Tampere, Pirkanmaa 33520
    Finland

    Active - Recruiting

  • Oulun yliopistollinen sairaala

    Oulu, Pohjois-pohjanmaa 90220
    Finland

    Active - Recruiting

  • Kuopion Yliopistollinen Sairaala

    Kuopio, Pohjois-savo 70210
    Finland

    Active - Recruiting

  • Turku University Hospital

    Turku, Varsinais-suomi 20520
    Finland

    Active - Recruiting

  • Helsinki university hospital

    Helsinki, 00290
    Finland

    Active - Recruiting

  • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

    Bordeaux, Aquitaine 33076
    France

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  • CHRU de Brest

    Brest, Finistère 29609
    France

    Site Not Available

  • Centre Hospitalier Privé Saint-Grégoire

    Saint Grégoire, Ille-et-vilaine 35760
    France

    Site Not Available

  • Institut de Cancérologie de l'Ouest

    Saint Herblain, Loire-atlantique 44805
    France

    Site Not Available

  • Institut Jean Godinot

    Reims, Marne 51726
    France

    Site Not Available

  • Clinique Victor Hugo Le Mans

    Le Mans, Pays-de-la-loire 72000
    France

    Site Not Available

  • Centre Leon Berard

    Lyon Cedex08, Rhône-alpes 69373
    France

    Site Not Available

  • Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne

    Clermont-Ferrand, 63011
    France

    Site Not Available

  • Institut Godinot

    Reims, 51100
    France

    Site Not Available

  • Studienpraxis Urologie

    Nürtingen, Baden-württemberg 72622
    Germany

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  • Universitaetsklinikum Tuebingen

    Tübingen, Baden-württemberg 72076
    Germany

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    Münster, Nordrhein-westfalen 48149
    Germany

    Active - Recruiting

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246
    Germany

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    Patras, Achaḯa 26504
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    Athens, Attikí 115 28
    Greece

    Site Not Available

  • Athens Medical Center

    Athens, Attikí 151 25
    Greece

    Site Not Available

  • Attikon General University Hospital

    Chaidari, Attikí 124 62
    Greece

    Site Not Available

  • University General Hospital of Larissa

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    Greece

    Site Not Available

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    Meldola, Emilia-romagna 47014
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  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

    Roma, Lazio 00168
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    Site Not Available

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    Roma, Lazio 00144
    Italy

    Active - Recruiting

  • Istituto Nazionale Tumori Regina Elena

    Rome, Roma 00144
    Italy

    Site Not Available

  • Azienda Socio Sanitaria Territoriale di Cremona

    Cremona, 26100
    Italy

    Site Not Available

  • Ospedale San Raffaele

    Milano, 20132
    Italy

    Site Not Available

  • Azienda Ospedaliera Santa Maria Terni

    Terni, 05100
    Italy

    Active - Recruiting

  • APSS- Presidio Ospedaliero S. Chiara

    Trento, 38122
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma

    Verona, 37134
    Italy

    Site Not Available

  • Chiba cancer center

    Chiba-shi, Chiba 260-8717
    Japan

    Active - Recruiting

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime 791-0280
    Japan

    Active - Recruiting

  • Hokkaido University Hospital

    Sapporo, Hokkaido 060-8648
    Japan

    Active - Recruiting

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido 003-0804
    Japan

    Active - Recruiting

  • Kobe University Hospital

    Kobe, Hyogo 650-0017
    Japan

    Active - Recruiting

  • Kanazawa University Hospital

    Kanazawa, Ishikawa 920-8641
    Japan

    Active - Recruiting

  • Yokohama City University Medical Center

    Yokohama, Kanagawa 232-0024
    Japan

    Active - Recruiting

  • Yokosuka Kyosai Hospital

    Yokosuka, Kanagawa 238-8558
    Japan

    Active - Recruiting

  • Osaka University Hospital

    Suita, Osaka 565-0871
    Japan

    Active - Recruiting

  • The University of Osaka Hospital

    Suita, Osaka 565-0871
    Japan

    Active - Recruiting

  • Keio university hospital

    Shinjuku-ku, Tokyo 1608582
    Japan

    Active - Recruiting

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395
    Japan

    Active - Recruiting

  • National Hospital Organization Kumamoto Medical Center

    Kumamoto, 860-0008
    Japan

    Active - Recruiting

  • Osaka International Cancer Institute

    Osaka, 541-8567
    Japan

    Active - Recruiting

  • Yamagata University Hospital

    Yamagata, 990-9585
    Japan

    Active - Recruiting

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeonranamdo 58128
    Korea, Republic of

    Site Not Available

  • National Cancer Center

    Goyang-si, Kyǒnggi-do 10408
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, Seoul-teukbyeolsi [seoul] 05505
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [seoul] 06351
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [seoul] 03080
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [seoul] 03722
    Korea, Republic of

    Active - Recruiting

  • Kyungpook National University Chilgok Hospital

    Daegu, Taegu-kwangyǒkshi 41404
    Korea, Republic of

    Active - Recruiting

  • Chungnam national university hospital

    Jung-gu, Taejǒn-kwangyǒkshi 35015
    Korea, Republic of

    Active - Recruiting

  • MICS Centrum Medyczne Torun

    Torun, Kujawsko-pomorskie 87-100
    Poland

    Site Not Available

  • Clinical Best Solutions

    Lublin, Lubelskie 20-011
    Poland

    Active - Recruiting

  • Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.

    Kraków, Małopolskie 30-348
    Poland

    Active - Recruiting

  • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie

    Kraków, Małopolskie 31-826
    Poland

    Active - Recruiting

  • Provita Profamilia

    Piotrków Trybunalski, Łódzkie 97-300
    Poland

    Active - Recruiting

  • CUIMED, s.r.o., Urologicka ambulancia

    Bratislava, 851 05
    Slovakia

    Active - Recruiting

  • Privatna urologicka ambulancia, s.r.o.

    Trencin, 911 01
    Slovakia

    Active - Recruiting

  • Cancercare Langenhoven Drive Oncology Centre

    Port Elizabeth, Eastern CAPE 6045
    South Africa

    Site Not Available

  • Wilgers Oncology Centre

    Pretoria, Gauteng 0081
    South Africa

    Site Not Available

  • Wits Clinical Research

    Soweto, Gauteng 2013
    South Africa

    Site Not Available

  • TASK Eden

    George, Western CAPE 6529
    South Africa

    Site Not Available

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050
    Spain

    Active - Recruiting

  • Södersjukhuset

    Stockholm, Stockholms LÄN [se-01] 11883
    Sweden

    Active - Recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung, 807
    Taiwan

    Active - Recruiting

  • Taichung Veterans General Hospital

    Taichung, 407
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital

    Tainan, 704
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Active - Recruiting

  • Royal Blackburn Hospital

    Blackburn, Blackburn WITH Darwen BB2 3HH
    United Kingdom

    Active - Recruiting

  • The Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN
    United Kingdom

    Site Not Available

  • Palo Verde Hematology Oncology

    Glendale, Arizona 85304
    United States

    Active - Recruiting

  • Arizona Urology Specialists (AUS)-Orange Grove

    Tucson, Arizona 85741
    United States

    Active - Recruiting

  • Arizona Urology Specialists (East Side Location)

    Tucson, Arizona 85715
    United States

    Active - Recruiting

  • Highlands Oncology

    Fayetteville, Arkansas 72703
    United States

    Site Not Available

  • Highlands Oncology

    Rogers, Arkansas 72758
    United States

    Site Not Available

  • Highlands Oncology Group

    Springdale, Arkansas 72762
    United States

    Site Not Available

  • Adventist Health Physicians Network

    Hidden Valley Lake, California 95467
    United States

    Active - Recruiting

  • Adventist Health Physicians Network

    Napa, California 94558
    United States

    Active - Recruiting

  • Adventist Health St. Helena

    Saint Helena, California 94574
    United States

    Active - Recruiting

  • Duly Health and Care (Bone Scintigraphy)

    Lisle, Illinois 60532
    United States

    Active - Recruiting

  • NextStage Clinical Research-Chicago-(04)

    Lisle, Illinois 60532
    United States

    Active - Recruiting

  • Blessing Hospital

    Quincy, Illinois 62301
    United States

    Active - Recruiting

  • Blessing Physician Services

    Quincy, Illinois 62301
    United States

    Active - Recruiting

  • Duly Health and Care (CT and MRI)

    Westmont, Illinois 60559
    United States

    Active - Recruiting

  • Adult & Pediatric Urology, PC

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Montefiore Medical Center - Medical Park

    Bronx, New York 10461
    United States

    Site Not Available

  • AUC Urologists, LLC

    Myrtle Beach, South Carolina 29572
    United States

    Active - Recruiting

  • Carolina Urologic Research Center, LLC

    Myrtle Beach, South Carolina 29572
    United States

    Active - Recruiting

  • Grand Strand Medical Center

    Myrtle Beach, South Carolina 29572
    United States

    Active - Recruiting

  • Parkway Surgery Center

    Myrtle Beach, South Carolina 29572
    United States

    Active - Recruiting

  • USA Clinical Trials

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Fred Hutchinson Cancer Center

    Seattle, Washington 98109
    United States

    Site Not Available

  • Harborview Medical Center

    Seattle, Washington 98104
    United States

    Site Not Available

  • University of Washington Medical Center - Montlake

    Seattle, Washington 98195
    United States

    Site Not Available

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