A phase III, randomized, open-label study of PF-06821497 (MEVROMETOSTAT) plus enzalutamide versus enzalutamide or docetaxel in participants with metastatic castration-resistant prostate cancer who had previously received abiraterone acetate (MEVPRO-1)

Study Identifier:
C2321014
CT.gov Identifier:
NCT06551324
EudraCT Identifier:
202451000000
EU Trial (CTIS) Number:
2024-511650-50-00
Study Contact Information:
N/A
Recruiting

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Study Summary

To evaluating whether combining the study medicine (PF-06821497) with enzalutamide is safe and effective compared to physician's choice of either second-line androgen receptor (AR) directed therapy with enzalutamide or docetaxel (chemotherapy) for treating metastatic castration-resistant prostate cancer (mCRPC) after progression on prior abiraterone acetate treatment. To evaluate radiographic progression-free survival (rPFS), overall survival (OS), and safety of mevrometostat plus enzalutamide compared with standard of care in patients with mCRPC previously treated with abiraterone. Main objective To demonstrate that PF-06821497 in combination with enzalutamide is superior to PCT of enzalutamide or docetaxel in prolonging rPFS.

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: Experimental: Arm A
    • Read More
  • Drug: Drug: PF-06821497
  • Drug: Drug: Enzalutamide
  • Drug: Active Comparator: Arm B
  • Drug: Experimental Drugs
  • Drug: ASCO GU 2025:
  • Drug: CTIS:
  • Drug: DEXAMETHASONE
    • 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 surgical or medical castration with evidence of disease progression on treatment with abiraterone acetate in the mCSPC setting or first line mCRPC setting is required.Eastern Cooperate Oncology Group (ECOG) performance status 0 - 2, with life expectancy of at least 6 months as assessed by the investigator.
    Exclusion criteria
    • Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may make the participant inappropriate for the study.Know 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.Prior treatment for prostate cancer at any stage with any cytotoxic chemotherapy, radioligand therapy (i.e. 177Lu-PSMA-617, radium 223), 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:Treatment with first-generation antiandrogen agents, if discontinued prior to first dose of study intervention.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 within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is shorter).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