AzTrials
AzTrials

Metastatic Castrate Resistant Prostate Cancer (mCRPC)Phase 3MEVPRO-1NCT06551324

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).

A Phase 3 study testing PF-06821497, Docetaxel and Enzalutamide in people with Metastatic Castrate Resistant Prostate Cancer (mCRPC), run by Pfizer at 224 sites in 23 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
PF-06821497, Docetaxel and Enzalutamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
609 participants
Where
224 sitesin 23 countries
Study dates
21 Oct 2024to 29 Oct 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features.
  • Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan.
  • Progressive disease in the setting of surgical or medical castration with evidence of disease progression on treatment with abiraterone acetate in the mCSPC setting or first line mCRPC setting is required.
  • Eastern Cooperate Oncology Group (ECOG) performance status 0 - 2, with life expectancy of at least 6 months as assessed by the investigator.

Who cannot join

  • Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may make the participant inappropriate for the study.
  • Know history of active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery.
  • Clinically significant cardiovascular disease.
  • Known or suspected brain metastasis or active leptomeningeal disease or clinically significant history of seizure.
  • Prior treatment for prostate cancer at any stage with any cytotoxic chemotherapy, radioligand therapy (i.e. 177Lu-PSMA-617, radium 223), androgen receptor signaling inhibitors (ARSi) including enzalutamide, apalutamide, darolutamide, poly ADP-ribose polymerase (PARP) monotherapy, CDK4/6 inhibitors, or other systemic anti-cancer treatment, with the following exceptions:
  • Treatment with first-generation antiandrogen agents, if discontinued prior to first dose of study intervention.
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  • Docetaxel treatment is allowed for mCSPC, as long as no signs of failure, or disease progression occurred during treatment or within 3 months of treatment completion.
  • Use of 5-alpha reductase inhibitors within 28 days of randomization.
  • Previous administration with an investigational product within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is longer).
  • Inadequate organ function.

Trial locations and contacts

224 sites in 23 countries.

224 sites in 23 countries

United States70 sites

  • Los Angeles Cancer Network

    Anaheim, California, 92805

  • University of Miami Sylvester Comprehensive Cancer Center - Aventura

    Aventura, Florida, 33180

  • UCSF Cancer Center Berkeley

    Berkeley, California, 94702

  • Florida Cancer Specialists

    Bradenton, Florida, 34211

  • UCSF Cancer Center Burlingame

    Burlingame, California, 94010

  • Florida Cancer Specialists

    Cape Coral, Florida, 33909

  • AtlantiCare Health Park - Cape May Court House

    Cape May Court House, New Jersey, 08210

  • Ironwood Cancer & Research Centers

    Chandler, Arizona, 85224

  • University of Miami Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center

    Coral Gables, Florida, 33146

  • University of Miami Sylvester Comprehensive Cancer Center - Deerfield Beach

    Deerfield Beach, Florida, 33442

  • University of Miami Hospital and Clinics - Doral

    Doral, Florida, 33166

  • AtlantiCare

    Egg Harbor, New Jersey, 08234

  • Florida Cancer Specialists

    Fort Myers, Florida, 33905

  • Florida Cancer Specialists

    Fort Myers, Florida, 33908

  • Los Angeles Cancer Network

    Fountain Valley, California, 92708

  • Ironwood Cancer & Research Centers

    Gilbert, Arizona, 85297

  • Ironwood Cancer & Research Centers

    Glendale, Arizona, 85306

  • Los Angeles Cancer Network

    Glendale, California, 91204

  • Los Angeles Cancer Network

    Glendale, California, 91206

  • Urology Centers of Alabama

    Homewood, Alabama, 35209

  • University of Miami Sylvester Comprehensive Cancer Center - Kendall

    Kendall, Florida, 33176

  • Colorado Clinical Research

    Lakewood, Colorado, 80228

  • The Centers for Advanced Urology, LLP d/b/a Keystone Urology Specialists

    Lancaster, Pennsylvania, 17604

  • Duly Health and Care

    Lisle, Illinois, 60532

  • NextStage Clinical Research-Chicago-(04)

    Lisle, Illinois, 60532

  • Los Angeles Cancer Network

    Los Angeles, California, 90017

  • Los Angeles Cancer Network

    Los Angeles, California, 90067

  • The University of Louisville, James Graham Brown Cancer Center

    Louisville, Kentucky, 40202

  • University of Louisville Hospital

    Louisville, Kentucky, 40202

  • UofL Health Medical Center Northeast

    Louisville, Kentucky, 40245

  • Ironwood Cancer & Research Centers

    Mesa, Arizona, 85202

  • Ironwood Cancer & Research Centers

    Mesa, Arizona, 85206

  • University of Miami Hospital and Clinics, Sylvester Cancer Center

    Miami, Florida, 33136

  • University of Miami Hospital and Clinics, UHealth Tower

    Miami, Florida, 33136

  • University of Miami Sylvester Comprehensive Cancer Center - Griffin Cancer Research Building

    Miami, Florida, 33136

  • Circuit Clinical /Crystal Run Healthcare LLP

    Middletown, New York, 10941

  • Circuit Clinical

    Middletown, New York, 10941

  • Crystal Run Healthcare

    Monroe, New York, 10950

  • AUC Urologists, LLC

    Myrtle Beach, South Carolina, 29572

  • Carolina Urologic Research Center, LLC

    Myrtle Beach, South Carolina, 29572

  • Grand Strand Medical Center

    Myrtle Beach, South Carolina, 29572

  • Parkway Surgery Center

    Myrtle Beach, South Carolina, 29572

  • Florida Cancer Specialists

    N. Venice, Florida, 34275

  • Florida Cancer Specialists

    Naples, Florida, 34102

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

  • AdventHealth Hematology and Oncology

    Orlando, Florida, 32804

  • AdventHealth Orlando Infusion Center

    Orlando, Florida, 32804

  • Stanford Cancer Center

    Palo Alto, California, 94305

  • Ironwood Cancer & Research Centers

    Phoenix, Arizona, 85028

  • University of Miami Sylvester Comprehensive Cancer Center - Plantation

    Plantation, Florida, 33324

  • Florida Cancer Specialists

    Port Charlotte, Florida, 33980

  • Salisbury VA Medical Center

    Salisbury, North Carolina, 28144

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • USA Clinical Trials

    San Antonio, Texas, 78229

  • UCSF Investigational Drug Pharmacy

    San Francisco, California, 94158

  • UCSF Medical Center at Mission Bay

    San Francisco, California, 94158

  • UCSF Cancer Center San Mateo

    San Mateo, California, 94402

  • Sutter Santa Rosa

    Santa Rosa, California, 95403

  • Florida Cancer Specialists

    Sarasota, Florida, 34236

  • Florida Cancer Specialists

    Sarasota, Florida, 34239

  • Ironwood Cancer & Research Centers

    Scottsdale, Arizona, 85260

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

  • University of Washington Medical Center - Montlake

    Seattle, Washington, 98195

  • VA St. Louis Health Care System

    St Louis, Missouri, 63106

  • Stanford Health Care Attention: Investigational Pharmacy

    Stanford, California, 94305

  • James J. Peters VA Medical Center

    The Bronx, New York, 10468

  • New England Cancer Specialists

    Topsham, Maine, 04086

  • New England Cancer Specialists

    Westbrook, Maine, 04092

  • Duly Health and Care

    Westmont, Illinois, 60559

Other trials in United States

China26 sites

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 510180

  • The Second Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi, 541199

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

    Hangzhou, Zhejiang, 310016

  • Huai'an First People's Hospital

    Huai'an, Jiangsu, 223300

  • The First Hospital of Jiaxing

    Jiaxing, Zhejiang, 314001

  • Lanzhou university second hospital

    Lanzhou, Gansu, 730030

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

    Nanjing, Jiangsu, 210008

  • Nantong Tumor Hospital

    Nantong, Jiangsu, 226361

  • The first affiliated hospital of Ningbo university

    Ningbo, Zhejiang, 315010

  • Tongji Hospital of Tongji University

    Shanghai, Shanghai Municipality, 200065

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110167

  • The First Hospital of China Medical University

    Shenyang, Liaoning

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215004

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

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

    Wuhan, Hubei, 430022

  • Wannan Medical College Yijishan Hospital

    Wuhu, Anhui, 241001

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

  • Shaanxi Provincial People' Hospital

    Xi'an, Shaanxi, 710068

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264099

Other trials in China

Japan15 sites

  • Chiba cancer center

    Chiba, Chiba, 260-8717

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

  • Kobe University Hospital

    Kobe, Hyōgo, 650-0017

  • National Hospital Organization Kumamoto Medical Center

    Kumamoto, 860-0008

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

  • Osaka International Cancer Institute

    Osaka, 541-8567

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Keio university hospital

    Shinjuku-ku, Tokyo, 1608582

  • The University of Osaka Hospital

    Suita, Osaka, 565-0871

  • Yamagata University Hospital

    Yamagata, 990-9585

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024

  • Yokosuka Kyosai Hospital

    Yokosuka, Kanagawa, 238-8558

Other trials in Japan

France13 sites

  • CHRU de Brest

    Brest, Finistère, 29200

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

    Clermont-Ferrand, 63011

  • Centre Oscar Lambret

    Lille, Hauts-de-France, 59020

  • Centre Leon Berard

    Lyon Cedex08, Auvergne-Rhône-Alpes, 69373

  • Centre Antoine-Lacassagne

    Nice, Alpes-maritimes, 06189

  • Centre Hospitalier Universitaire de Nîmes - Institut de Cancérologie du Gard - Hôpital Universitaire

    Nîmes, GARD, 30029

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, Rhône, 69310

  • Institut Jean Godinot

    Reims, Marne, 51726

  • Centre Hospitalier Privé Saint-Grégoire

    Saint-Grégoire, Ille-et-vilaine, 35760

  • Hopitaux Universitaire de Strasbourg - Hopital Hautepierre

    Strasbourg, Bas-rhin, 67091

  • Hôpital Foch

    Suresnes, Hauts-de-seine, 92151

  • Oncopole Claudius Regaud

    Toulouse, Haute-garonne, 31059

  • Gustave Roussy

    Villejuif, Val-de-marne, 94800

Other trials in France

Spain10 sites

  • Hospital Clínic de Barcelona

    Barcelona, Catalunya [cataluña], 08036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalunya [cataluña], 08041

  • Institut Català d'Oncologia - L'Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, Comunidad de, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, Comunidad de, 28041

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050

  • Althaia, Xarxa Assistencial Universitària de Manresa

    Manresa, 8423

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

Turkey (Türkiye)10 sites

  • Adana City Hospital

    Adana, 01370

  • Gulhane Egitim Arastirma Hastanesi

    Ankara, 06010

  • Memorial Ankara Hastanesi

    Ankara, 06520

  • Gazi University Health Research and Application Center Gazi Hospital

    Ankara, 06560

  • Ankara University Health Practice and Research Hospitals

    Ankara, 06620

  • I.E.U. Medical Point Hastanesi

    Cordaleo, İzmir, 35575

  • Koç Üniversitesi Hastanesi

    Istanbul, İ̇stanbul, 34010

  • Istanbul Universitesi Cerrahpasa

    Istanbul, İ̇stanbul, 34668

  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

    Istanbul, İ̇stanbul, 34722

  • Marmara Universitesi Pendik Egitim Arastirma Hastanesi

    Istanbul, İ̇stanbul, 34899

Other trials in Turkey (Türkiye)

Argentina8 sites

  • IMAXE

    Buenos Aires, C1120

  • Asociación de Beneficencia Hospital Sirio Libanés

    Buenos Aires, C1419AHN

  • Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC)

    Buenos Aires, C1431FWO

  • Centro de Urología (CDU)

    CABA, Buenos Aires, C1120AAT

  • Centro Medico Privado CEMAIC

    Capital, Córdoba Province, X5008HHW

  • Instituto Alexander Fleming

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ

  • Imagenes Mdq

    Mar del Plata, Buenos Aires, 7600

  • Instituto de Investigaciones Clínicas Mar del Plata

    Mar del Plata, Buenos Aires, B7600FZO

Other trials in Argentina

Brazil8 sites

  • Hospital São Carlos

    Fortaleza, Ceará, 60135-237

  • Crio - Centro Regional Integrado de Oncologia

    Fortaleza, Ceará, 60336232

  • Hospital São Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

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

    Santo André, São Paulo, 09060-650

  • Hospital de Base de São José do Rio Preto

    São José do Rio Preto, São Paulo, 15090-000

  • Hospital Alemao Oswaldo Cruz

    São Paulo, São Paulo, 01327-001

  • Instituto do Cancer Arnaldo Vieira de Carvalho

    São Paulo, 01221-020

  • IBCC - Núcleo de Pesquisa e Ensino

    São Paulo, 04014-002

Other trials in Brazil

South Korea8 sites

  • Kyungpook National University Chilgok Hospital

    Daegu, Taegu-kwangyǒkshi, 41404

  • National Cancer Center

    Goyang-si, Kyǒnggi-do, 10408

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeonranamdo, 58128

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [seoul], 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [seoul], 03722

  • Asan Medical Center

    Seoul, Seoul-teukbyeolsi [seoul], 05505

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [seoul], 06351

  • Ewha Womans University Mokdong Hospital

    Seoul, Seoul-teukbyeolsi [seoul], 07985

Other trials in South Korea

Poland7 sites

  • Regionalny Szpital Specjalistyczny im. dr. Władyslawa Biegańskiego

    Grudziądz, Kuyavian-Pomeranian Voivodeship, 86-300

  • Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie

    Koszalin, 75-581

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

    Krakow, Lesser Poland Voivodeship, 30-348

  • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie

    Krakow, Lesser Poland Voivodeship, 31-826

  • SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu

    Opole, Opole Voivodeship, 45-061

  • MICS Centrum Medyczne Torun

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • 4 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ

    Wroclaw, Lower Silesian Voivodeship, 50-981

Other trials in Poland

United Kingdom7 sites

  • Royal Blackburn Hospital

    Blackburn, Blackburn WITH Darwen, BB2 3HH

  • Western General Hospital

    Edinburgh, Midlothian, EH4 2XU

  • The Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • University College London Hospitals NHS Trust

    London, NW1 2PG

  • The Clatterbridge Cancer Centre

    Metropolitan Borough of Wirral, CH63 4JY

  • Singleton Hospital

    Swansea, SA2 8QA

  • Mid and South Essex NHS Foundation Trust

    Westcliff-on-Sea, Essex, SS0 0RY

Other trials in United Kingdom

Taiwan6 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • Taichung Veterans General Hospital

    Taichung, 407

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 100225

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333

Other trials in Taiwan

Germany5 sites

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Urologie Neandertal - Praxis Mettmann

    Mettmann, North Rhine-Westphalia, 40822

  • Universitätsklinikum Münster - Albert Schweitzer Campus

    Münster, North Rhine-Westphalia, 48149

  • Studienpraxis Urologie

    Nürtingen, Baden-Wurttemberg, 72622

  • Universitaetsklinikum Tuebingen

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Canada4 sites

  • Arthur J.E. Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

  • Centre Hospitalier de l'Université de Montréal

    Montreal, Quebec, H2X 3E4

  • Sunnybrook Research Institute

    Toronto, Ontario, M4N 3M5

  • BC Cancer Vancouver

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Czechia4 sites

  • Fakultni nemocnice Olomouc

    Olomouc, Olomouc Region, 779 00

  • Multiscan

    Pardubice, Pardubice Region, 53203

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, Praha 10, 10034

  • Fakultni Thomayerova nemocnice

    Prague, Praha 4, 14059

Other trials in Czechia

Greece4 sites

  • Alexandra General Hospital of Athens

    Athens, Attikí, 115 28

  • Athens Medical Center

    Athens, Attikí, 151 25

  • Metropolitan General Hospital

    Athens, Attikí, 155 62

  • University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"

    Chaïdári, Attikí, 124 62

Other trials in Greece

Netherlands4 sites

  • Meander Medisch Centrum

    Amersfoort, Utrecht, 3813 TZ

  • Tergooi MC

    Hilversum, North Holland, 1212 VG

  • Frisius Medisch Centrum

    Leeuwarden, Provincie Friesland, 8934 AD

  • Canisius-Wilhelmina Ziekenhuis

    Nijmegen, Gelderland, 6532 SZ

Other trials in Netherlands

Slovakia4 sites

  • Vychodoslovensky onkologicky ustav, a.s.

    Košice, 041 91

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

    Prešov, 08 001

  • BEKY - MED, s.r.o.

    Prešov, 080 01

  • Fakultna nemocnica Trnava

    Trnava, 917 02

Other trials in Slovakia

Australia3 sites

  • Icon Cancer Centre Wesley

    Auchenflower, Queensland, 4066

  • Monash Health

    Clayton, Victoria, 3168

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

Other trials in Australia

Italy3 sites

  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"

    Meldola, Emilia-Romagna, 47014

  • Ospedale San Raffaele

    Milan, 20132

  • Istituto Nazionale Tumori Regina Elena

    Rome, Lazio, 00144

Other trials in Italy

Hungary2 sites

  • Országos Onkológiai Intézet

    Budapest, Pest County, 1122

  • Petz Aladar Egyetemi Oktato Korhaz

    Győr, Győr-Moson-Sopron, 9024

Other trials in Hungary

Sweden2 sites

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, Västra Götalands LÄN [se-14], 413 45

  • Södersjukhuset

    Stockholm, Stockholms LÄN [se-01], 11883

Other trials in Sweden

South Africa1 site

  • Wits Clinical Research

    Johannesburg, Gauteng, 2193

Other trials in South Africa

About this study

Official title: A PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF PF-06821497 (MEVROMETOSTAT) IN COMBINATION WITH ENZALUTAMIDE COMPARED WITH ENZALUTAMIDE OR DOCETAXEL IN PARTICIPANTS WITH METASTATIC CASTRATION RESISTANT PROSTATE CANCER PREVIOUSLY TREATED WITH ABIRATERONE ACETATE (MEVPRO-1)

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.

Being tested
PF-06821497, Docetaxel, Enzalutamide
Keywords
Prostate cancer, Enhancer of zeste homolog 2, castrate resistant prostate cancer, Hormone resistant, Metastatic hormone resistant prostate cancer, Metastatic castrate resistant prostate cancer, PF-06821497, Enzalutamide, Docetaxel, Advanced prostate cancer, Efficacy, Safety, Open-label, Relapsed, refractory
Medical subject headings
Prostatic Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-06821497Drug

    Also called Mevrometostat

    875 mg BID (2 times a day)

  • DocetaxelDrug

    Also called Taxotere

    75 mg/m2 IV (every 21 days)

  • EnzalutamideDrug

    Also called XTANDI

    160 mg QD

Study groups in NCT06551324
Study groupRoleWhat they receive
Arm BActive comparatorComparator Arm B: Physician's choice of enzalutamide 160 mg QD or docetaxel 75 mg/m2 intravenous (IV) every 21 days
Receives: Drug: Docetaxel; Drug: Enzalutamide
Arm AExperimentalInvestigational Arm A: PF-06821497 875 mg twice daily (BID) + enzalutamide 160 mg every day (QD)
Receives: Drug: PF-06821497; Drug: Enzalutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radiographic Progression Free Survival (rPFS) assessed by blinded independent central review (BICR) per RECIST v1.1 and Prostate Cancer Clinical Trials Working Group 3 (PCWG3)

    rPFS is defined as the time from the date of randomization to first objective evidence of radiographic progression as assessed in soft tissue per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or in bone per Prostate Cancer Clinical Trials Working Group 3 (PCWG3) guidelines by BICR, or death, whichever occurs first.

    Measured: Randomization up to approximately 2 years.

Secondary outcomes (23)

  1. Overall survival (OS)

    OS is defined as the time from the date of randomization to the date of death due to any cause.

    Measured: Randomization up to approximately 4.5 years.

  2. Objective Response (ORR)

    The objective response rate is defined as the proportion of participants with measurable soft tissue disease at baseline who have a confirmed objective response of complete response (CR) or partial response (PR) per RECIST v1.1.

    Measured: Randomization up to approximately 2 years.

  3. Duration of Response (DoR) in measurable soft tissue disease

    The DoR is defined as the first objective evidence of soft tissue response (CR or PR, whichever is earlier) to radiographic progression or death due to any cause whichever occurs first.

    Measured: Randomization up to approximately 2 years.

  4. Time to prostate specific antigen (PSA) progression.

    Proportion of participants with PSA response ≥50% in participants with detectable PSA values at baseline.

    Measured: Randomization up to approximately 2 years.

  5. Time to initiation of antineoplastic therapy.

    Time from randomization to first use of new antineoplastic therapy.

    Measured: Randomization up to approximately 4.5 years.

  6. Prostate Specific Antigen Response

    Proportion of participants with PSA response ≥50% in participants with detectable PSA values at baseline.

    Measured: Randomization up to approximately 2 years.

  7. Incidence of Adverse Events

    Type, incidence, severity [as graded by National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) v5.0], seriousness and relationship to study medications of AEs.

    Measured: Randomization up to approximately 4.5 years

  8. Time to first symptomatic skeletal event

    Time from randomization to first symptomatic skeletal event (symptomatic bone fractures, spinal cord compression, surgery or radiation to the bone whichever is first).

    Measured: Randomization up to approximately 2 years.

  9. Change from baseline in patient reported pain symptoms per Brief Pain Inventory-Short Form (BPI-SF)

    Analysis of Brief Pain Inventory-Short Form (BPI-SF) will be based on the pain severity score (mean of individual BPI-SF items 3, 4, 5 and 6), the pain interference score (mean of items 9A-9G), and the single BPI-SF Item 3 which asks the patient to rate pain at its worst in the last 24 hours.

    Measured: Randomization up to approximately 4.5 years

  10. Change from baseline in health-related quality of life (HRQoL) per Functional Assessment of Cancer Therapy - Prostate (FACT-P)

    Change from baseline in HRQoL (FACT-P total score) will be presented. The FACT-P total score will be calculated based on the participant responses to the 39 items in the FACT-P questionnaire. Each item is rated on a 0 to 4 Likert-type scale and then combined to produce the FACT-P total score (0-156), with higher scores representing better health-related quality of life.

    Measured: Randomization to approximately 4.5 years

  11. Change from baseline in social/family well-being per Functional Assessment of Cancer Therapy - Prostate (FACT-P)

    Change from baseline in social/family well-being score will be presented. The social/family well-being score will be calculated based on 7 items in the FACT-P questionnaire; score range 0-28. Each item is rated on a 0 to 4 Likert-type scale

    Measured: Randomization up to approximately 4.5 years

  12. Change from baseline in emotional well-being per Functional Assessment of Cancer Therapy - Prostate (FACT-P)

    Change from baseline in emotional well-being score will be presented. The emotional well-being score will be calculated based on 6 items in the FACT-P questionnaire; score range 0-24. Each item is rated on a 0 to 4 Likert-type scale

    Measured: Randomization up to approximately 4.5 years

  13. Change from baseline in functioning well-being per Functional Assessment of Cancer Therapy - Prostate (FACT-P)

    Change from baseline in functioning well-being score will be presented. The functioning well-being score will be calculated based on 7 items in the FACT-P questionnaire; score range 0-28. Each item is rated on a 0 to 4 Likert-type scale

    Measured: Randomization up to approximately 4.5 years

  14. Change from baseline in physical well-being per Functional Assessment of Cancer Therapy - Prostate (FACT-P)

    Change from baseline in physical well-being score will be presented. The physical well-being score will be calculated based on 7 items in the FACT-P questionnaire; score range 0-28. Each item is rated on a 0 to 4 Likert-type scale

    Measured: Randomization to approximately 4.5 years

  15. Change from baseline in symptoms per Functional Assessment of Cancer Therapy - Prostate (FACT-P)

    Change from baseline prostate cancer symptoms (PCS) score will be presented. The PCS score will be calculated based on 12 items in the FACT-P questionnaire; score range 0-48. Each item is rated on a 0 to 4 Likert-type scale

    Measured: Randomization up to approximately 4.5 years

  16. Change from baseline in patient reported health status per European Quality of Life 5-Dimension 5 Level (EQ-5D-5L)

    Participants will self-rate their current state of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression by choosing 1 of 5 possible responses that record the level of severity (no problems, slight problems, moderate problems, severe problems, or extreme problems) within each dimension. The questionnaire also includes a visual analog scale to self-rate general health state on a scale from "the worst health you can imagine" to "the best health you can imagine."

    Measured: Randomizaton up to approximately 4.5 years

  17. Symptomatic toxicity as measured by items from the Patient-Reported Outcome CTCAE (PRO-CTCAE)

    Each selected PRO-CTCAE items will be assessed related to one or more attributes that include counts for the frequency, severity, and/or interference with usual or daily activities.

    Measured: Randomization up to approximately 4.5 years

  18. Overall side effect burden as measured by the FACT- GP5

    The FACT-GP5 question assesses overall side effect burden with the following response options "I am bothered by side effects of treatment," is rated on a 5-point scale ranging from "not at all" (0) to "very much" (4) and counts will be presented.

    Measured: Randomization to approximately 4.5 years

  19. Time to confirmatory deterioration in patient-reported pain symptoms per BPI-SF Item 3 "worst pain in 24 hours"

    Defined as the time from randomization to onset of pain progression, which is defined as > 2-point increase from baseline in the score from the BPI-SF Question 3 that is confirmed at the next consecutive assessment > 4 weeks apart or an initial deterioration followed by death before the next assessment

    Measured: Randomization up to approximately 4.5 years

  20. Time to definitive deterioration in patient-reported health related quality of life (HRQoL) per FACT-P

    Defined as the time from randomization to onset of definitive deterioration in FACT-P total score, which is defined as >10 point decrease from baseline and no subsequent observations with a <10 point decrease from baseline FACT-P total score

    Measured: Randomization up to approximately 4.5 years

  21. Time to definitive deterioration in patient-reported physical well-being per FACT-P

    Time to definitive deterioration in physical well-being (PWB) per FACT-P is defined as the time from randomization to onset of definitive deterioration in physical well-being, which is defined as ≥3-point

    Measured: Randomization up to approximately 4.5 years

  22. To evaluate the PK of PF-06821497 when dosed with enzalutamide

    PK characterized by pre-dose trough and post-dose plasma concentrations of PF-06821497 at selected visits.

    Measured: Cycle 1 (each cycle is 28 days), Day 1 to last PK draw at the end of Cycle 6, Day 1.

  23. To assess circulating tumor DNA (ctDNA) at baseline and on treatment to evaluate tumor burden.

    Evaluation of ctDNA burden at baseline and on study.

    Measured: Baseline up to approximately 2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2024
  2. Study start21 Oct 2024
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion29 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
609 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06551324
Sponsor's protocol ID
C2321014
Other IDs
2024-511650-50-00
Acronym
MEVPRO-1
Status last verified
Oct 2026
First submitted
25 Jul 2024
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • Shore ND, Fizazi K, Schweizer MT, Castro E, Azad AA, George DJ, da Trindade KM, Zeng H, Shrivastava N, Tonkovyd S, Bock A, Nekkalapudi S, Tang Y, Lin S, Agarwal N. Phase III randomized studies of mevrometostat and enzalutamide in metastatic prostate cancer (MEVPRO-1 and MEVPRO-2): trial protocols. Future Oncol. 2026 May;22(12):1397-1408. doi: 10.1080/14796694.2026.2667441. Epub 2026 May 10.

    PubMed 42108644

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PF-06821497, Docetaxel and Enzalutamide in people with Metastatic Castrate Resistant Prostate Cancer (mCRPC), run by Pfizer at 224 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 224 sites in United States, China, Japan, France, Spain and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiographic Progression Free Survival (rPFS) assessed by blinded independent central review (BICR) per RECIST v1.1 and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) (time frame: Randomization up to approximately 2 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06551324, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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