Tests mevrometostat with enzalutamide in men with advanced prostate cancer
Tests mevrometostat plus enzalutamide, compared with placebo, in men with advanced prostate cancer.
Plain-language title generated from the registry record
Registry title: A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.
Key facts
- Where
- Cracow, Grudziądz, Koszalin, Lublin, Opole, Piotrkow Trybunalski, Torun, Warsaw, and Wroclaw, PolandSee the 10 sites
- Phase
- Phase 3
Where in Poland
- Jagiellonskie Centrum Innowacji Sp. z o.o.Cracow, PolandNo longer taking part
- Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.Cracow, PolandNo longer taking part
- Regionalny Szpital Specjalistyczny im. Dr. Wladyslawa BieganskiegoGrudziądz, PolandNo longer taking part
- Szpital Wojewodzki im. Mikolaja Kopernika w KoszalinieKoszalin, PolandNo longer taking part
- Clinical Best Solutions Sp. z o.o. S.K.Lublin, PolandNo longer taking part
- Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki ZdrowotnejOpole, PolandNo longer taking part
- Provita Centrum Medyczne Sp. z o.o.Piotrkow Trybunalski, PolandNo longer taking part
- Mics Centrum Medyczne TorunTorun, PolandNo longer taking part
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyWarsaw, PolandNo longer taking part
- 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We WroclawiuWroclaw, PolandNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Pfizer
- Trial code
- NCT06629779EU 2024-511652-40-00
- Record updated
- 30 October 2026
- Original description
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.Read full original descriptionShow less
A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF PF-06821497 (MEVROMETOSTAT) WITH ENZALUTAMIDE IN METASTATIC CASTRATION RESISTANT PROSTATE CANCER (MEVPRO-2)
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.
Inclusion: 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 medical or surgical castration; ECOG performance status 0 or 1, with a life expectancy of ≥12 months as assessed by the investigator.
Exclusion: Known history of active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery; Participants must be treatment naïve at the mCRPC stage, eg, no cytotoxic chemotherapy, radio-ligand therapy (i.e. 177Lu- PSMA-617), CDK4/6 inhibitors, 5-alpha reductase inhibitors for prostate cancer in any setting, 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:; Treatment with first-generation antiandrogen (ADT) agents, estrogens, progestins, cyproterone acetate; 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 (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is longer); Clinically significant cardiovascular disease; Known or suspected brain metastasis or active leptomeningeal disease or clinically significant history of seizure; Any history of myelodysplastic syndrome, acute myeloid leukemia, or any other prior malignancy with a few exceptions; Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that make the participant inappropriate for the study; Inadequate organ function.