A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1).

Last updated: January 27, 2025
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

3

Condition

Prostate Cancer, Early, Recurrent

Prostate Disorders

Prostate Cancer

Treatment

Docetaxel

Enzalutamide

PF-06821497

Clinical Study ID

NCT06551324
C2321014
2024-511650-50-00
  • Ages > 18
  • Male

Study Summary

Pfizer MEVPRO-1 (C2321014) is a randomized, open-label, multi-center clinical trial evaluating whether combining the study medicine (PF-06821497) with enzalutamide is safe and effective compared to physician's choice of either second-line androgen receptor (AR) directed therapy with enzalutamide or docetaxel (chemotherapy) for treating metastatic castration-resistant prostate cancer (mCRPC) after progression on prior abiraterone acetate treatment.

The primary objective of this clinical trial is to assess the radiographic progression free survival (rPFS) of the combination of PF-06821497 plus enzalutamide versus physician's choice of enzalutamide or docetaxel.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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.

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

  • Eastern Cooperate Oncology Group (ECOG) performance status 0 - 2, with lifeexpectancy of at least 6 months as assessed by the investigator.

Exclusion

Exclusion Criteria:

  • Any medical or psychiatric condition including recent (within the past year) oractive suicidal ideation/behavior or laboratory abnormality that may make theparticipant. inappropriate for the study.

  • Clinically significant cardiovascular disease.

  • Known or suspected brain metastasis or active leptomeningeal disease or clinicallysignificant history of seizure.

  • Prior treatment for prostate cancer at any stage with any cytotoxic chemotherapy,radioligand therapy, androgen receptor signaling inhibitors (ARSi) includingenzalutamide, apalutamide, darolutamide, poly ADP-ribose polymerase (PARP)monotherapy or other systemic anti-cancer treatment. with the following exceptions:

  1. Treatment with first-generation antiandrogen agents, if discontinued prior torandomization

  2. Docetaxel treatment is allowed for mCSPC, as long as no signs of failure, ordisease progression occurred during treatment or within 3 months of treatmentcompletion.

  • Previous administration with an investigational product within 30 days or 5half-lives preceding the first dose of study intervention (whichever is shorter).

  • Inadequate organ function.

Study Design

Total Participants: 600
Treatment Group(s): 3
Primary Treatment: Docetaxel
Phase: 3
Study Start date:
October 21, 2024
Estimated Completion Date:
October 29, 2028

Connect with a study center

  • Centro de Urología (CDU)

    Caba, Buenos Aires C1120AAT
    Argentina

    Site Not Available

  • Hospital Sirio Libanes

    Capital Federal, Buenos Aires C1419AHN
    Argentina

    Site Not Available

  • Imagenes Mdq

    Mar del Plata, Buenos Aires 7600
    Argentina

    Site Not Available

  • Instituto de Investigaciones Clínicas Mar del Plata

    Mar del Plata, Buenos Aires B7600FZO
    Argentina

    Site Not Available

  • Asociación de Beneficencia Hospital Sirio Libanés

    Buenos Aires, C1419AHN
    Argentina

    Site Not Available

  • Icon Cancer Centre Wesley

    Auchenflower, Queensland 4066
    Australia

    Site Not Available

  • Monash Health

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Site Not Available

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

    Santo André, SÃO Paulo 09060-650
    Brazil

    Site Not Available

  • Wannan Medical College Yijishan Hospital

    Wuhu, Anhui 241001
    China

    Site Not Available

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing 100050
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing, Beijing 100191
    China

    Site Not Available

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing 400030
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fuzhou, Fujian 350014
    China

    Active - Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian 350001
    China

    Site Not Available

  • Lanzhou university second hospital

    Lanzhou, Gansu 730030
    China

    Site Not Available

  • The Second Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi 541199
    China

    Active - Recruiting

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

    Wuhan, Hubei 430022
    China

    Active - Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan 410013
    China

    Active - Recruiting

  • Huai'an First People's Hospital

    Huai'an, Jiangsu 223300
    China

    Site Not Available

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu 210000
    China

    Site Not Available

  • Nantong Tumor Hospital

    Nantong, Jiangsu 226361
    China

    Site Not Available

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215004
    China

    Active - Recruiting

  • 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

    Active - Recruiting

  • 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, Zhejiang 310016
    China

    Active - Recruiting

  • 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

    Site Not Available

  • Multiscan

    Pardubice, Pardubický KRAJ 53203
    Czechia

    Site Not Available

  • Nukleární Medicína

    Hradec Králové, 500 05
    Czechia

    Site Not Available

  • Radiodiagnostika Pardubice

    Pardubice, 53003
    Czechia

    Site Not Available

  • Institut de cancérologie Strasbourg Europe (ICANS)

    Strasbourg, Alsace 67033
    France

    Site Not Available

  • Istituto Nazionale Tumori Regina Elena

    Rome, Roma 00144
    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

  • 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

    Active - Recruiting

  • Asan Medical Center

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

    Site Not Available

  • Ewha Womans University Mokdong Hospital

    Seoul, Seoul-teukbyeolsi [seoul] 07985
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

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

    Active - Recruiting

  • Seoul National University Hospital

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

    Site Not Available

  • Severance Hospital, Yonsei University Health System

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

    Site Not Available

  • Kyungpook National University Chilgok Hospital

    Daegu, Taegu-kwangyǒkshi 41404
    Korea, Republic of

    Site Not Available

  • Tergooiziekenhuizen, locatie Hilversum

    Hilversum, Noord-holland 1212 VG
    Netherlands

    Site Not Available

  • Meander Medisch Centrum

    Amersfoort, Utrecht 3813 TZ
    Netherlands

    Active - Recruiting

  • MICS Centrum Medyczne Torun

    Torun, Kujawsko-pomorskie 87-100
    Poland

    Site Not Available

  • BEKY - MED, s.r.o.

    Presov, 080 01
    Slovakia

    Site Not Available

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

    Presov, 08 001
    Slovakia

    Site Not Available

  • Hospital Clínic de Barcelona

    Barcelona, Catalunya [cataluña] 08036
    Spain

    Site Not Available

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, Comunidad DE 28034
    Spain

    Site Not Available

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung, 807
    Taiwan

    Site Not Available

  • Taichung Veterans General Hospital

    Taichung, 407
    Taiwan

    Site Not Available

  • 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

    Site Not Available

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333
    Taiwan

    Site Not Available

  • Arizona Urology Specialists (AUS)-Orange Grove

    Tucson, Arizona 85741
    United States

    Active - Recruiting

  • Arizona Urology Specialists- Provide ICF for Review Only

    Tucson, Arizona 85715
    United States

    Active - Recruiting

  • Colorado Clinical Research

    Lakewood, Colorado 80228
    United States

    Site Not Available

  • Duly Health and Care

    Hinsdale, Illinois 60521
    United States

    Active - Recruiting

  • Duly Health And Care

    Lisle, Illinois 60532
    United States

    Active - Recruiting

  • NextStage Clinical Research-Chicago-(04)

    Lisle, Illinois 60532
    United States

    Active - Recruiting

  • Duly Health and Care

    Westmont, Illinois 60559
    United States

    Active - Recruiting

  • AtlantiCare

    Egg Harbor Township, New Jersey 08234
    United States

    Site Not Available

  • Salisbury VA Medical Center

    Salisbury, North Carolina 28144
    United States

    Site Not Available

  • Keystone Urology Specialists

    Lancaster, Pennsylvania 17604
    United States

    Active - Recruiting

  • AUC Urologists, LLC

    Myrtle Beach, South Carolina 29572
    United States

    Site Not Available

  • Carolina Urologic Research Center, LLC

    Myrtle Beach, South Carolina 29572
    United States

    Site Not Available

  • Grand Strand Medical Center

    Myrtle Beach, South Carolina 29572
    United States

    Site Not Available

  • Parkway Surgery Center

    Myrtle Beach, South Carolina 29572
    United States

    Site Not Available

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Baptist M&S Imaging (Medical Center)

    San Antonio, Texas 78229
    United States

    Site Not Available

  • USA Clinical Trials

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Huntsman Cancer Institute

    Salt Lake City, Utah 84112
    United States

    Site Not Available

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