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).
Launched by PFIZER · Aug 9, 2024
Trial Information
Current as of July 09, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called MEVPRO-1, is looking at a new medicine called PF-06821497 (Mevrometostat) to see if it can help men with metastatic castrate-resistant prostate cancer (mCRPC) who have previously been treated with another medication called abiraterone acetate. In this study, researchers want to find out if combining PF-06821497 with another drug, enzalutamide, is safer and more effective than just using enzalutamide alone or another treatment called docetaxel (a type of chemotherapy). The main goal is to see how long patients can live without their cancer getting worse when using this combination treatment.
To be eligible for this trial, participants need to be men aged 65 and older with confirmed prostate cancer that has spread to other parts of the body. They should also be experiencing disease progression despite being on hormone therapy. However, those with certain health conditions, such as significant heart disease or previous treatments for prostate cancer with specific drugs, cannot participate. If someone joins the trial, they can expect regular check-ups and monitoring to see how well the treatment is working and to ensure their safety throughout the study.
Gender
MALE
Eligibility criteria
- Inclusion Criteria:
- • 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.
- Exclusion Criteria:
- • 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 or other systemic anti-cancer treatment, with the following exceptions:
- • 1. Treatment with first-generation antiandrogen agents, if discontinued prior to first dose of study intervention.
- • 2. 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.
- • Previous administration with an investigational product within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is shorter).
- • Inadequate organ function.
About Pfizer
Pfizer Inc. is a global leader in biopharmaceutical innovation, dedicated to discovering, developing, and delivering advanced therapies that enhance patient outcomes across a wide range of medical conditions. With a rich history of scientific research and a commitment to quality, Pfizer focuses on areas such as oncology, immunology, cardiology, and rare diseases. The company leverages cutting-edge technology and collaborates with healthcare professionals, regulatory bodies, and academic institutions to conduct rigorous clinical trials that ensure the safety and efficacy of its products. Pfizer's mission is to bring breakthroughs that change patients' lives, exemplifying its commitment to health and wellness worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
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Seattle, Washington, United States
Madrid, , Spain
Sarasota, Florida, United States
Sapporo, Hokkaido, Japan
Homewood, Alabama, United States
Seattle, Washington, United States
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Swansea, , United Kingdom
Bonita Springs, Florida, United States
Naples, Florida, United States
Port Charlotte, Florida, United States
Venice, Florida, United States
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Kashiwa, Chiba, Japan
Sapporo, Hokkaido, Japan
Glasgow, , United Kingdom
Villejuif, , France
Milano, , Italy
Yamagata, , Japan
Taichung, , Taiwan
Tainan, , Taiwan
Hamburg, , Germany
Kaohsiung, , Taiwan
Kobe, Hyogo, Japan
Suita, Osaka, Japan
Seoul, , Korea, Republic Of
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Bratislava, , Slovakia
Martin, , Slovakia
Melbourne, Victoria, Australia
Prague, , Czechia
Kanazawa, Ishikawa, Japan
Yokohama, Kanagawa, Japan
Yokosuka, Kanagawa, Japan
Seoul, , Korea, Republic Of
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Fort Myers, Florida, United States
Barcelona, , Spain
Louisville, Kentucky, United States
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Nijmegen, Gelderland, Netherlands
Matsuyama, Ehime, Japan
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Taoyuan, , Taiwan
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Bronx, New York, United States
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Guangzhou, Guangdong, China
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Changsha, Hunan, China
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Lanzhou, Gansu, China
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Toronto, Ontario, Canada
Wuhan, Hubei, China
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Osaka, , Japan
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Guangzhou, Guangdong, China
Nanjing, Jiangsu, China
Roma, Lazio, Italy
Seoul, , Korea, Republic Of
Kosice, , Slovakia
Cape Coral, Florida, United States
Clayton, Victoria, Australia
Madrid, , Spain
Madrid, , Spain
Nürtingen, , Germany
Hangzhou, Zhejiang, China
Huai'an, Jiangsu, China
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Glendale, Arizona, United States
Chiba Shi, Chiba, Japan
Nantong, Jiangsu, China
Gothenburg, , Sweden
Melbourne, , Australia
Yantai, Shandong, China
Chongqing, , China
Topsham, Maine, United States
Vancouver, British Columbia, Canada
Edinburgh, Midlothian, United Kingdom
Tübingen, , Germany
Fuzhou, Fujian, China
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Auchenflower, Queensland, Australia
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
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Pierre Bénite, Rhône, France
Gyor, , Hungary
València, , Spain
Lancaster, Pennsylvania, United States
Port Elizabeth, Eastern Cape, South Africa
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San Francisco, California, United States
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Nürtingen, Baden Württemberg, Germany
Goyang Si, Kyǒnggi Do, Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
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Nice, Alpes Maritimes, France
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Jiaxing, Zhejiang, China
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Xi'an, Shaanxi, China
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Port Elizabeth, Eastern Cape, South Africa
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George, Western Cape, South Africa
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Daegu, Taegu Kwangyǒkshi, Korea, Republic Of
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Wuhu, Anhui, China
Prague, , Czechia
Münster, Nordrhein Westfalen, Germany
Blackburn, Blackburn With Darwen, United Kingdom
Myrtle Beach, South Carolina, United States
Tübingen, Baden Württemberg, Germany
Koszalin, Zachodniopomorskie, Poland
São Paulo, , Brazil
Chaidari, Attikí, Greece
Athens, Attikí, Greece
Wroclaw, Dolnośląskie, Poland
Stockholm, , Sweden
Hwasun, Jeonranamdo, Korea, Republic Of
Torun, , Poland
Santo André, São Paulo, Brazil
Nice, Alpes Maritimes, France
Rome, Roma, Italy
Lyon Cedex08, Rhône Alpes, France
Reims, Marne, France
Cheng Du, Sichuan, China
Ankara, , Turkey
Phoenix, Arizona, United States
Kraków, Małopolskie, Poland
Monroe, New York, United States
Ningbo, Zhejiang, China
Meldola, Emilia Romagna, Italy
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Manresa, , Spain
Mettmann, Nordrhein Westfalen, Germany
Nashville, Tennessee, United States
Guilin, Guangxi, China
Athens, , Greece
Trnava, , Slovakia
Santo André, , Brazil
São Paulo, , Brazil
Suresnes, Hauts De Seine, France
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Hilversum, Noord Holland, Netherlands
Nîmes, Gard, France
Buenos Aires, , Argentina
Brest, , France
San Antonio, Texas, United States
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Hinsdale, Illinois, United States
Lisle, Illinois, United States
Westmont, Illinois, United States
Gilbert, Arizona, United States
Mesa, Arizona, United States
Scottsdale, Arizona, United States
San Mateo, California, United States
Tucson, Arizona, United States
Myrtle Beach, South Carolina, United States
Sao Paulo, São Paulo, Brazil
Ankara, , Turkey
Tucson, Arizona, United States
Egg Harbor Township, New Jersey, United States
Caba, Buenos Aires, Argentina
Capital Federal, Buenos Aires, Argentina
Mar Del Plata, Buenos Aires, Argentina
Hradec Králové, , Czechia
Pardubice, , Czechia
Presov, , Slovakia
Presov, , Slovakia
Shenyang, Liaoning, China
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Clermont Ferrand, , France
Westbrook, Maine, United States
Suita, Osaka, Japan
Santa Rosa, California, United States
Toulouse, Haute Garonne, France
Saint Grégoire, Ille Et Vilaine, France
Athens, Attikí, Greece
Leeuwarden, Fryslân, Netherlands
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Hilversum, Noord Holland, Netherlands
Martin, , Slovakia
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Capital, , Argentina
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Pardubice, , Czechia
L'hospitalet De Llobregat, , Spain
Lyon Cedex08, , France
Kraków, , Poland
Wroclaw, , Poland
Chaidari, , Greece
Athens, , Greece
Leeuwarden, , Netherlands
İstanbul, , Turkey
N. Venice, Florida, United States
Fortaleza, , Brazil
Grudziądz, Kujawsko Pomorskie, Poland
Patients applied
Trial Officials
Pfizer CT.gov Call Center
Study Director
Pfizer
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported