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Clinical Trials List

Protocol NumberC2321003
NCT Number(ClinicalTrials.gov Identfier)NCT06629779
Active

2024-11-01 - 2031-09-30

Phase III

Recruiting5

ICD-10C61

Malignant neoplasm of prostate

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9185

Malignant neoplasm of prostate

A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF PF-06821497 (MEVROMETOSTAT) WITH ENZALUTAMIDE IN METASTATIC CASTRATION RESISTANT PROSTATE CANCER (MEVPRO-2)

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/04/22

Investigators and Locations

Principal Investigator CHUNG-HSIN CHEN Division of Urology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chuan-Shu Chen Division of Urology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hsiao-Jen Chung Division of Urology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shu-Pin Huang Division of Urology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Pin Su
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Metastatic Castration-Resistant Prostate Cancer

Objectives

Learn about the efficacy of the investigational drug PF-06821497 (Mevrometostat) in men with metastatic castration-resistant prostate cancer who have not previously received innovative hormone therapy or chemotherapy (MEVPRO-2).

Test Drug

Tablets Soft Capsules

Active Ingredient

PF-06821497
6808400400

Dosage Form

110
132

Dosage

125 mg, 250mg
40mg

Endpoints

BICR (Blinded Independent Central Review) assessed rPFS according to RECIST (Responsive Criteria for Solid Tumor Response) version 1.1 (soft tissue diseases) and PCWG3 (Prostate Cancer Working Group 3) (bone diseases).

Inclution Criteria

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

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:

Treatment with first-generation antiandrogen (ADT) agents, estrogens, progestins, cyproterone acetate;
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.

The Estimated Number of Participants

  • Taiwan

    35 participants

  • Global

    900 participants

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