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.

Sponsor: Pfizer

Sponsor score: 60

ClinicalTrials ID:NCT07028853

This Phase 3, double-blind study evaluates mevrometostat plus enzalutamide versus placebo plus enzalutamide in mCSPC patients who are ARPI naïve and have not received systemic anticancer treatments, except ADT. Participants are randomized 1:1 to receive either the investigational drug or placebo, both with enzalutamide. The study includes screening, treatment, and follow-up phases.

Patient Parameters

Program Overview

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.

Description

This is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study evaluating mevrometostat in combination with enzalutamide versus placebo in combination with enzalutamide in participants with mCSPC who have not received systemic anticancer treatments with the exception of androgen-deprivation therapy (ADT) and first-generation antiandrogen agents. Prior therapy with up to 3 months of ADT (chemical or surgical) is allowed, with no radiographic evidence of disease progression or rising PSA levels prior to Day 1.

This study consists of a Screening Phase, Randomization, Treatment Phase, Safety Follow-up, and Long-Term Follow-up. Participants will be randomized on a 1:1 basis to receive (Arm A) mevrometostat (PF-06821497) in combination with enzalutamide, or (Arm B) placebo in combination with enzalutamide.

Eligibility Criteria

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.
  • 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.

Locations

FACILITYZIPCITYSTATE
Ironwood Cancer & Research Centers85224ChandlerArizona
Ironwood Cancer & Research Centers85297GilbertArizona
Ironwood Cancer & Research Centers85306GlendaleArizona
Ironwood Cancer & Research Centers85395GoodyearArizona
Ironwood Cancer & Research Centers85202MesaArizona
Ironwood Cancer & Research Centers85206MesaArizona
Ironwood Cancer & Research Centers85028PhoenixArizona
Ironwood Cancer & Research Centers85260ScottsdaleArizona
Highlands Oncology Group, PA72703FayettevilleArkansas
Highlands Oncology Group, PA72758RogersArkansas

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