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
- Bordeaux, Brest, Clermont Ferrand Cedex1, Le Mans, Lyon, Pierre-Bénite, Reims, Saint-Grégoire, Saint-Herblain Cedex, and Strasbourg, FranceSee the 10 sites
- Phase
- Phase 3
Where in France
- Institut BergonieBordeaux, FranceNo longer taking part
- Centre Hospitalier Régional et Universitaire de BrestBrest, FranceNo longer taking part
- Centre Jean PerrinClermont Ferrand Cedex1, FranceNo longer taking part
- Clinique Victor HugoLe Mans, FranceNo longer taking part
- Centre Leon BerardLyon, FranceNo longer taking part
- Hospices Civils de LyonPierre-Bénite, FranceNo longer taking part
- Institut GodinotReims, FranceNo longer taking part
- Centre Hospitalier Prive Saint GregoireSaint-Grégoire, FranceNo longer taking part
- Institut De Cancerologie De L OuestSaint-Herblain Cedex, FranceNo longer taking part
- Les Hôpitaux Universitaires de Strasbourg - Hôpital de HautepierreStrasbourg, FranceNo 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.