A Phase III, Randomized, Double Blind, Placebo Controlled Study of Pf-06821497 (Mevrometostat) With Enzalutamide in Metastatic Castration Resistant Prostate Cancer (Mevpro-2)

Study Identifier:
C2321003
CT.gov Identifier:
NCT06629779
EudraCT Identifier:
202451000000
EU Trial (CTIS) Number:
2024-511652-40-00
Study Contact Information:
N/A
Recruiting

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Study Summary

This study will explore whether a combination of the investigational drug PF-06821497 and enzalutamide will work better than taking enzalutamide alone in participants with mCRPC who are ARSi or abiraterone naïve.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Prostate
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    III
    Sex
    Male
    Age
    18+ years
    Study Drug
  • Drug: ACTIVE COMPARATOR: Arm B
    • Read More
  • Drug: Participants will receive Placebo BID (twice daily) + enzalutamide 160 mg QD (once daily)
  • Drug: Drug: Enzalutamide
  • Drug: Oral continuous
  • Drug: Other Names: Xtandi
  • Drug: Drug: Placebo
  • Drug: EXPERIMENTAL: Arm A
  • Drug: Participants will receive PF-06821497 (875 mg) BID (twice daily) + enzalutamide 160 mg QD (once daily)
  • Drug: Drug: PF-06821497
  • Drug: Other Names: Mevrometostat
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • * 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.
    • * Progressive disease in the setting of medical or surgical castration.
    • * ECOG performance status 0 or 1, with a life expectancy of ≥12 months as assessed by the investigator.
    Exclusion criteria
    • Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that make the participant inappropriate for the study.
    • * Known history of active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery.
    • * Clinically significant cardiovascular disease.
    • * Known or suspected brain metastasis or active leptomeningeal disease or clinically significant history of seizure.
    • * Any history of myelodysplastic syndrome, acute myeloid leukemia, or any other prior malignancy with a few exceptions.
    • * Participants must be treatment naïve at the mCRPC stage, eg, no cytotoxic chemotherapy, radio-ligand therapy (i.e. 177Lu- PSMA-617), CDK4/6 inhibitors, 5-alpha reductase inhibitors for prostate cancer in any setting, androgen receptor signaling inhibitors (ARSi) including enzalutamide, apalutamide, darolutamide, poly ADP-ribose polymerase (PARP) monotherapy or other systemic anti-cancer treatment with the following exceptions:
    • 1. Treatment with first-generation antiandrogen (ADT) agents, estrogens, progestins, cyproterone acetate;
    • 2. Docetaxel treatment is allowed for mCSPC, as long as no signs of failure, or disease progression occurred during treatment or within 3 months of treatment completion.
    • * Previous administration with an investigational product (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is longer).
    • * Inadequate organ function.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Carolinas
    Myrtle Beach, SC, United States, 29572
    Investigator
    Neal Shore
    Status
    Recruiting
    Condition(s) Treated at Site
    Prostate