Tests mevrometostat with enzalutamide in men with early spreading prostate cancer
Tests mevrometostat plus enzalutamide, compared with enzalutamide alone, in adult men with prostate cancer.
Plain-language title generated from the registry record
Registry title: This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking Enzalutamide Alone in Participants With mCSPC Who Are ARPI naïve.
Key facts
- Where
- Curitiba, Fortaleza, Ijuí, Porto Alegre, Santo André, São José do Rio Preto, São Paulo, and Sorocaba, BrazilSee the 11 sites
- Phase
- Phase 3
Where in Brazil
- Hospital Erasto GaertnerCuritiba, BrazilNo longer taking part
- Crio - Centro Regional Integrado de OncologiaFortaleza, BrazilNo longer taking part
- ONCOSITE - Centro de Pesquisa Clinica em OncologiaIjuí, BrazilNo longer taking part
- Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e PesquisaPorto Alegre, BrazilNo longer taking part
- CEPHO - Centro de Estudos e Pesquisas de Hematologia e OncologiaSanto André, BrazilNo longer taking part
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio PretoSão José do Rio Preto, BrazilNo longer taking part
- BP - A Beneficência Portuguesa de São PauloSão Paulo, BrazilNo longer taking part
- Hospital Alemão Oswaldo CruzSão Paulo, BrazilNo longer taking part
- IBCC - Núcleo de Pesquisa e EnsinoSão Paulo, BrazilNo longer taking part
- Instituto do Cancer Arnaldo Vieira de CarvalhoSão Paulo, BrazilNo longer taking part
- Centro de Estudos e Pesquisas Oncologia de Sorocaba (CEPOS)Sorocaba, BrazilNo 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
- NCT07028853EU 2024-519369-24-00
- Record updated
- 14 October 2026
- Original description
This study will explore whether a combination of the investigational drug mevrometostat (PF-06821497) and enzalutamide will work better than taking enzalutamide alone in participants with mCSPC who are ARPI naïve and have not yet received chemotherapy in the mCSPC setting.Read full original descriptionShow less
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF MEVROMETOSTAT (PF-06821497) WITH ENZALUTAMIDE IN METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MEVPRO-3)
This study will explore whether a combination of the investigational drug mevrometostat (PF-06821497) and enzalutamide will work better than taking enzalutamide alone in participants with mCSPC who are ARPI naïve and have not yet received chemotherapy in the mCSPC setting.
Inclusion: Male participants aged ≥18 years (or the minimum age of consent in accordance with local regulations) at screening; Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features; Metastatic prostate cancer documented by positive bone scan (for bone disease) or metastatic lesion(s) on CT or MRI (for soft tissue/visceral disease); Resolution of acute effects of any prior therapy to either baseline severity or CTCAE Grade ≤1 (except for AEs which do not constitute a safety risk in the investigator's judgement); Participants must have ECOG PS 0 or 1.
Exclusion: Participants must be treatment naïve at the mCSPC stage, eg, participants cannot have received any cytotoxic chemotherapy with the following exceptions: Treatment with first-generation antiandrogen (ADT) agents is allowed for mCSPC; Previous administration with an investigational product (drug or vaccine) within 30 days; Use of 5-alpha reductase inhibitors is prohibited within 28 days of randomization; Prior surgery from which the participant has not fully recovered at least 28 days prior to randomization; Current use or anticipated need for drugs that are known strong CYP3A4/5 inhibitors and inducers (with exception of enzalutamide as part of this study); Clinically significant cardiovascular disease; Known or suspected brain metastasis or active leptomeningeal disease; Known allergic or hypersensitivity reactions to mevrometostat or its excipients or to enzalutamide or its excipients; Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study; Inadequate organ function.