MEVPRO-2 - C2321003 - A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF PF-06821497 (MEVROMETOSTAT) WITH ENZALUTAMIDE IN METASTATIC CASTRATION RESISTANT PROSTATE CANCER.

Studio Clinico

Patologia: Carcinoma della prostata

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: Sì

Fase di studio: III

Linee di trattamento: Non applicabile

Criteri di inclusione: 

- 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 disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan.
- Surgically or medically castrated, with serum testosterone ≤50 ng/dL (≤1.73 nmol/L) at screening.
- 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.
- Prior to randomization, there must be resolution of acute effects of any prior therapy to either baseline severity or CTCAE Grade ≤1.
- ECOG performance status 0 or 1, with a life expectancy of ≥12 months as assessed by the investigator.

Criteri di esclusione: 

- 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 mCRPC stage, eg, participants cannot have received any cytotoxic chemotherapy with the following exceptions: Treatment with first-generation antiandrogen (ADT) agents and. Docetaxel treatment is allowed for mCSPC.
- Previous administration with an investigational product (drug or vaccine) within 30 days.
- 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).
- Major surgery or palliative localized radiation therapy within 14 days before randomization.
- Inadequate organ function.

Numero di pazienti previsti: 

54

Schema di trattamento: 

- Experimental: Arm A
Mevrometostat (875 mg) BID (twice daily) + enzalutamide 160 mg QD (once daily).
- Active Comparator: Arm B
Placebo BID (twice daily) + enzalutamide 160 mg QD (once daily).

Trattamento sperimentale: 

Mevrometostat + Enzalutamide

Trattamento di controllo: 

Placebo + Enzalutamide

Obiettivi primari dello studio: 

Radiographic Progression Free Survival (rPFS)

Data di inizio dell'arruolamento: 10.01.2024

Data di fine dell'arruolamento: 28.06.2026

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2024-511652-40-00

Data di inserimento: 24.04.2025

Data di aggiornamento: 18.12.2025

Promotore

Pfizer

Principal Investigator ITALIA

Riferimento: Dr. Info non applicabile

Telefono: 00000

Email: na@na.it

Localita: na