Informations générales (source: ClinicalTrials.gov)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Mevrometostat (PF-06821497) With Enzalutamide in Metastatic Castration-Sensitive Prostate Cancer (MEVPRO-3)
Interventional
Phase 3
Pfizer (Voir sur ClinicalTrials)
septembre 2025
décembre 2034
11 juin 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Alice BERNARD TESSIER | 18/05/2026 09:40:04 | Contacter | ||
Critères
Homme
Inclusion Criteria
- 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 Criteria
- 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.
- Clinically significant cardiovascular disease.
- Known or suspected brain metastasis or active leptomeningeal disease.
- 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).
- Inadequate organ function.
- 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 Criteria
- 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.
- Clinically significant cardiovascular disease.
- Known or suspected brain metastasis or active leptomeningeal disease.
- 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).
- Inadequate organ function.