ClinicalTrialsFinder

RecruitingPhase 3NCT06551324

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, 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)

Sponsor

Pfizer

Enrollment

600 participants

Start Date

Oct 21, 2024

Study Type

INTERVENTIONAL

Conditions

Metastatic Castrate Resistant Prostate Cancer (mCRPC)

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a drug called mevrometostat (PF-06821497) in men with advanced prostate cancer that has spread (metastatic castration-resistant prostate cancer, or mCRPC) and stopped responding to a drug called abiraterone acetate. Mevrometostat works by blocking a protein that helps cancer cells grow. **You may be eligible if...** - You are a man with prostate cancer that has spread to bones or soft tissue - Your cancer progressed while on abiraterone acetate (with or without other hormone therapy) - You are in reasonable overall health (ECOG 0-2) with at least 6 months life expectancy **You may NOT be eligible if...** - You have previously received chemotherapy, PARP inhibitors, other hormone-blocking drugs (like enzalutamide or apalutamide), or radioligand therapies for prostate cancer - You have brain metastases or a history of seizures - You have significant heart disease or serious gastrointestinal problems - You have psychiatric conditions or recent suicidal thoughts Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPF-06821497

875 mg BID (2 times a day)

DRUGDocetaxel

75 mg/m2 IV (every 21 days)

DRUGEnzalutamide

160 mg QD

Locations(233)

Urology Centers of Alabama

Homewood, Alabama, United States

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

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

Los Angeles Cancer Network

Anaheim, California, United States

UCSF Cancer Center Berkeley

Berkeley, California, United States

UCSF Cancer Center Burlingame

Burlingame, California, United States

Los Angeles Cancer Network

Fountain Valley, California, United States

Los Angeles Cancer Network

Glendale, California, United States

Los Angeles Cancer Network

Glendale, California, United States

Los Angeles Cancer Network

Los Angeles, California, United States

Los Angeles Cancer Network

Los Angeles, California, United States

Stanford Cancer Center

Palo Alto, California, United States

UCSF Investigational Drug Pharmacy

San Francisco, California, United States

UCSF Medical Center at Mission Bay

San Francisco, California, United States

UCSF Cancer Center San Mateo

San Mateo, California, United States

Sutter Santa Rosa

Santa Rosa, California, United States

Stanford Health Care Attention: Investigational Pharmacy

Stanford, California, United States

Colorado Clinical Research

Lakewood, Colorado, United States

University of Miami Sylvester Comprehensive Cancer Center - Aventura

Aventura, Florida, United States

Florida Cancer Specialists

Bonita Springs, Florida, United States

Florida Cancer Specialists

Bradenton, Florida, United States

Florida Cancer Specialists

Cape Coral, Florida, United States

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

Coral Gables, Florida, United States

University of Miami Sylvester Comprehensive Cancer Center - Deerfield Beach

Deerfield Beach, Florida, United States

University of Miami Hospital and Clinics - Doral

Doral, Florida, United States

Florida Cancer Specialists

Fort Myers, Florida, United States

Florida Cancer Specialists

Fort Myers, Florida, United States

University of Miami Sylvester Comprehensive Cancer Center - Kendall

Kendall, Florida, United States

University of Miami Hospital and Clinics, Sylvester Cancer Center

Miami, Florida, United States

University of Miami Hospital and Clinics, UHealth Tower

Miami, Florida, United States

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

Miami, Florida, United States

Florida Cancer Specialists

N. Venice, Florida, United States

Florida Cancer Specialists

Naples, Florida, United States

AdventHealth Hematology and Oncology

Orlando, Florida, United States

AdventHealth Orlando Infusion Center

Orlando, Florida, United States

University of Miami Sylvester Comprehensive Cancer Center - Plantation

Plantation, Florida, United States

Florida Cancer Specialists

Port Charlotte, Florida, United States

Florida Cancer Specialists

Sarasota, Florida, United States

Duly Health and Care

Lisle, Illinois, United States

NextStage Clinical Research-Chicago-(04)

Lisle, Illinois, United States

Duly Health and Care

Westmont, Illinois, United States

The University of Louisville, James Graham Brown Cancer Center

Louisville, Kentucky, United States

University of Louisville Hospital

Louisville, Kentucky, United States

UofL Health Medical Center Northeast

Louisville, Kentucky, United States

New England Cancer Specialists

Topsham, Maine, United States

New England Cancer Specialists

Westbrook, Maine, United States

VA St. Louis Health Care System

St Louis, Missouri, United States

AtlantiCare Health Park - Cape May Court House

Cape May Court House, New Jersey, United States

AtlantiCare

Egg Harbor, New Jersey, United States

Circuit Clinical /Crystal Run Healthcare LLP

Middletown, New York, United States

Circuit Clinical

Middletown, New York, United States

Crystal Run Healthcare

Monroe, New York, United States

James J. Peters VA Medical Center

The Bronx, New York, United States

Salisbury VA Medical Center

Salisbury, North Carolina, United States

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

Lancaster, Pennsylvania, United States

AUC Urologists, LLC

Myrtle Beach, South Carolina, United States

Carolina Urologic Research Center, LLC

Myrtle Beach, South Carolina, United States

Grand Strand Medical Center

Myrtle Beach, South Carolina, United States

Parkway Surgery Center

Myrtle Beach, South Carolina, United States

Sarah Cannon Research Institute, LLC

Nashville, Tennessee, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

USA Clinical Trials

San Antonio, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Harborview Medical Center

Seattle, Washington, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

University of Washington Medical Center - Montlake

Seattle, Washington, United States

Centro de Urología (CDU)

CABA, Buenos Aires, Argentina

Instituto Alexander Fleming

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Imagenes Mdq

Mar del Plata, Buenos Aires, Argentina

Instituto de Investigaciones Clínicas Mar del Plata

Mar del Plata, Buenos Aires, Argentina

Centro Medico Privado CEMAIC

Capital, Córdoba Province, Argentina

IMAXE

Buenos Aires, Argentina

Asociación de Beneficencia Hospital Sirio Libanés

Buenos Aires, Argentina

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

Buenos Aires, Argentina

Icon Cancer Centre Wesley

Auchenflower, Queensland, Australia

Monash Health

Clayton, Victoria, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Hospital São Carlos

Fortaleza, Ceará, Brazil

Crio - Centro Regional Integrado de Oncologia

Fortaleza, Ceará, Brazil

Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

Santo André, São Paulo, Brazil

Hospital de Base de São José do Rio Preto

São José do Rio Preto, São Paulo, Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto

São José do Rio Preto, São Paulo, Brazil

Hospital Alemao Oswaldo Cruz

São Paulo, São Paulo, Brazil

Instituto do Cancer Arnaldo Vieira de Carvalho

São Paulo, Brazil

IBCC - Núcleo de Pesquisa e Ensino

São Paulo, Brazil

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

BC Cancer Vancouver

Vancouver, British Columbia, Canada

Sunnybrook Research Institute

Toronto, Ontario, Canada

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Wannan Medical College Yijishan Hospital

Wuhu, Anhui, China

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Lanzhou university second hospital

Lanzhou, Gansu, China

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

Southern Medical University Nanfang Hospital

Guangzhou, Guangdong, China

The Second Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Huai'an First People's Hospital

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 Hospital of China Medical University

Shenyang, Liaoning, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Shaanxi Provincial People' Hospital

Xi'an, Shaanxi, China

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Tongji Hospital of Tongji University

Shanghai, Shanghai Municipality, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The First Hospital of Jiaxing

Jiaxing, Zhejiang, China

The first affiliated hospital of Ningbo university

Ningbo, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Fakultni nemocnice Olomouc

Olomouc, Olomouc Region, Czechia

Multiscan

Pardubice, Pardubice Region, Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, Praha 10, Czechia

Fakultni Thomayerova nemocnice

Prague, Praha 4, Czechia

Nukleární Medicína

Hradec Králové, Czechia

Radiodiagnostika Pardubice

Pardubice, Czechia

Centre Antoine Lacassagne

Nice, Alpes-maritimes, France

Centre Antoine-Lacassagne

Nice, Alpes-maritimes, France

Centre Leon Berard

Lyon Cedex08, Auvergne-Rhône-Alpes, France

Hopitaux Universitaire de Strasbourg - Hopital Hautepierre

Strasbourg, Bas-rhin, France

CHRU de Brest

Brest, Finistère, France

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

Nîmes, GARD, France

Oncopole Claudius Regaud

Toulouse, Haute-garonne, France

Centre Oscar Lambret

Lille, Hauts-de-France, France

Hôpital Foch

Suresnes, Hauts-de-seine, France

Centre Hospitalier Privé Saint-Grégoire

Saint-Grégoire, Ille-et-vilaine, France

Institut Jean Godinot

Reims, Marne, France

Centre Hospitalier Lyon Sud

Pierre-Bénite, Rhône, France

Gustave Roussy

Villejuif, Val-de-marne, France

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

Clermont-Ferrand, France

Studienpraxis Urologie

Nürtingen, Baden-Wurttemberg, Germany

Universitaetsklinikum Tuebingen

Tübingen, Baden-Wurttemberg, Germany

Urologie Neandertal - Praxis Mettmann

Mettmann, North Rhine-Westphalia, Germany

Universitätsklinikum Münster - Albert Schweitzer Campus

Münster, North Rhine-Westphalia, Germany

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, Germany

Alexandra General Hospital of Athens

Athens, Attikí, Greece

Athens Medical Center

Athens, Attikí, Greece

Metropolitan General Hospital

Athens, Attikí, Greece

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

Chaïdári, Attikí, Greece

Petz Aladar Egyetemi Oktato Korhaz

Győr, Győr-Moson-Sopron, Hungary

Országos Onkológiai Intézet

Budapest, Pest County, Hungary

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

Meldola, Emilia-Romagna, Italy

Istituto Nazionale Tumori Regina Elena

Rome, Lazio, Italy

Ospedale San Raffaele

Milan, Italy

Chiba cancer center

Chiba, Chiba, Japan

National Cancer Center Hospital East

Kashiwa, 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

Yokohama City University Medical Center

Yokohama, Kanagawa, 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

Canisius-Wilhelmina Ziekenhuis

Nijmegen, Gelderland, Netherlands

Tergooi MC

Hilversum, North Holland, Netherlands

Frisius Medisch Centrum

Leeuwarden, Provincie Friesland, Netherlands

Meander Medisch Centrum

Amersfoort, Utrecht, Netherlands

Regionalny Szpital Specjalistyczny im. dr. Władyslawa Biegańskiego

Grudziądz, Kuyavian-Pomeranian Voivodeship, Poland

MICS Centrum Medyczne Torun

Torun, Kuyavian-Pomeranian Voivodeship, Poland

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

Krakow, Lesser Poland Voivodeship, Poland

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie

Krakow, Lesser Poland Voivodeship, Poland

4 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ

Wroclaw, Lower Silesian Voivodeship, Poland

Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego

Opole, Opole Voivodeship, Poland

Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie

Koszalin, Poland

Vychodoslovensky onkologicky ustav, a.s.

Košice, Slovakia

MILAB, s.r.o., Urologicka ambulancia

Prešov, Slovakia

BEKY - MED, s.r.o.

Prešov, Slovakia

Fakultna nemocnica Trnava

Trnava, Slovakia

Cancercare Langenhoven Drive Oncology Centre

Port Elizabeth, Eastern Cape, South Africa

Wits Clinical Research

Johannesburg, Gauteng, South Africa

Wilgers Oncology Centre

Pretoria, Gauteng, South Africa

TASK Eden

George, Western Cape, South Africa

Chonnam National University Hwasun Hospital

Hwasun, Jeonranamdo, South Korea

National Cancer Center

Goyang-si, Kyǒnggi-do, South Korea

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [seoul], South Korea

Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [seoul], South Korea

Asan Medical Center

Seoul, Seoul-teukbyeolsi [seoul], South Korea

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

Daegu, Taegu-kwangyǒkshi, South Korea

Institut Català d'Oncologia - L'Hospitalet

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Clínic de Barcelona

Barcelona, Catalunya [cataluña], Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalunya [cataluña], Spain

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Comunidad de, Spain

Hospital Universitario 12 de Octubre

Madrid, Madrid, Comunidad de, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

Hospital Universitario HM Sanchinarro

Madrid, Spain

Althaia, Xarxa Assistencial Universitària de Manresa

Manresa, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

Södersjukhuset

Stockholm, Stockholms LÄN [se-01], Sweden

Sahlgrenska Universitetssjukhuset

Gothenburg, Västra Götalands LÄN [se-14], Sweden

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, Taiwan

I.E.U. Medical Point Hastanesi

Cordaleo, İzmir, Turkey (Türkiye)

Koç Üniversitesi Hastanesi

Istanbul, İ̇stanbul, Turkey (Türkiye)

Istanbul Universitesi Cerrahpasa

Istanbul, İ̇stanbul, Turkey (Türkiye)

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

Istanbul, İ̇stanbul, Turkey (Türkiye)

Marmara Universitesi Pendik Egitim Arastirma Hastanesi

Istanbul, İ̇stanbul, Turkey (Türkiye)

Adana City Hospital

Adana, Turkey (Türkiye)

Gulhane Egitim Arastirma Hastanesi

Ankara, Turkey (Türkiye)

Memorial Ankara Hastanesi

Ankara, Turkey (Türkiye)

Gazi University Health Research and Application Center Gazi Hospital

Ankara, Turkey (Türkiye)

Ankara University Health Practice and Research Hospitals

Ankara, Turkey (Türkiye)

Royal Blackburn Hospital

Blackburn, Blackburn WITH Darwen, United Kingdom

Mid and South Essex NHS Foundation Trust

Westcliff-on-Sea, Essex, United Kingdom

Western General Hospital

Edinburgh, Midlothian, United Kingdom

The Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

University College London Hospitals NHS Trust

London, United Kingdom

The Clatterbridge Cancer Centre

Metropolitan Borough of Wirral, United Kingdom

Singleton Hospital

Swansea, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

NCT06551324

Related Trials

Study of Alpha Radioligand Therapy AB001 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

NCT072149613 locations

Dose Optimisation and Prostate-Specific Membrane Antigen (PSMA) Receptor intensification with 177Lu-PSMA Therapy: A Randomised Phase II trial: OPTIMAL-PSMA

ACTRN126250009714371 location

Personalized vs. Fixed-Activity 177Lu-PSMA-617 Radiopharmaceutical Therapy (PRODIGY-2)

NCT069434951 location

Kidney Function and Risk Factors in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Undergoing 177Lutetium-PSMA Radioligand Therapy: a Prospective Observational Study - KiRi-Trial

NCT067205321 location