MEVPRO-3 - C2321008 - A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Mevrometostat (PF-06821497) With Enzalutamide in Metastatic Castration-Sensitive Prostate Cancer.

Studio Clinico

Patologia: Carcinoma della prostata

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: Sì

Fase di studio: III

Linee di trattamento: Prima linea

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 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.

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 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.
- 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.

Numero di pazienti previsti: 

39

Schema di trattamento: 

Experimental: Arm A
Participants will receive mevrometostat (875 mg) BID (twice daily) + enzalutamide 160 mg QD (once daily)

Active Comparator: Arm B
Participants will receive 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) defined as the time from randomization until PD based on BICR assessment per RECIST v1.1 (soft tissue disease) and PCWG3 (bone disease), or death due to any cause, whichever occurs first.

Centri partecipanti

Nord Italia

Centro Italia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2024-519369-24-00

Data di inserimento: 03.04.2026

Promotore

Pfizer

Principal Investigator ITALIA

Riferimento: Dr. - -

Telefono: 00000

Email: na@na.it

Localita: -