Not currently recruiting at University of California Health

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.

a study on Prostate Cancer

Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
study ends around

Description

Summary

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.

Official Title

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

Details

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.

Keywords

Metastatic Castration Sensitive Prostate Cancer (mCSPC), Hormone Sensitive Prostate Cancer, Prostate Cancer, Cancer of the Prostate, Mevrometostat, Metastatic castration sensitive prostate cancer, PF-06821497, EZH2, enhancer of zeste homologue-2, enzalutamide, mCSPC, HSPC, castrate sensitive prostate cancer, prostatecancer-study.com, Phase 3, efficacy, safety, pharmacokinetics, pharmacodynamics, Prostatic Neoplasms, PF06821497

Eligibility

You can join if…

Open to males ages 18 years and up

  • 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.

You CAN'T join if...

  • 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

  • UCLA Hematology/Oncology - Alhambra not yet accepting patients
    Alhambra California 91801 United States
  • UCLA Hematology/Oncology - Beverly Hills not yet accepting patients
    Beverly Hills California 90212 United States
  • UCLA Hematology/Oncology - Burbank not yet accepting patients
    Burbank California 91505 United States
  • UCLA Hematology/Oncology - Encino not yet accepting patients
    Encino California 91436 United States
  • UCLA Hematology/Oncology - Irvine not yet accepting patients
    Irvine California 92604 United States
  • UCLA Hematology/Oncology - Laguna Hills not yet accepting patients
    Laguna Hills California 92653 United States
  • Ronald Reagan UCLA Medical Center - Drug Information Center not yet accepting patients
    Los Angeles California 90095 United States
  • UCLA Department of Medicine - Hematology/Oncology not yet accepting patients
    Los Angeles California 90095 United States
  • UCLA Hematology/Oncology not yet accepting patients
    Los Angeles California 90095 United States
  • UCLA Hematology/Oncology - Marina del Rey not yet accepting patients
    Marina del Rey California 90292 United States
  • UCLA Hematology/Oncology - Pasadena not yet accepting patients
    Pasadena California 91105 United States
  • UCLA Hematology/Oncology - Porter Ranch not yet accepting patients
    Porter Ranch California 91326 United States
  • UCLA Hematology/Oncology- Santa Monica not yet accepting patients
    Santa Monica California 90404 United States
  • UCLA Hematology/Oncology - Torrance not yet accepting patients
    Torrance California 90505 United States
  • UCLA Hematology/Oncology - Santa Clarita not yet accepting patients
    Valencia California 91355 United States
  • UCLA Hematology/Oncology - Ventura not yet accepting patients
    Ventura California 93003 United States
  • UCLA Hematology/Oncology - Westlake not yet accepting patients
    Westlake Village California 91361 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
ID
NCT07028853
Phase
Phase 3 Prostate Cancer Research Study
Study Type
Interventional
Participants
Expecting 1000 study participants
Last Updated