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Investigating PF-06821497 for men with advanced prostate cancer

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

Phase 3 Interventional Pfizer · NCT06629779

This study is testing if a new drug called PF-06821497 can help men with advanced prostate cancer feel better when used with a standard treatment compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment900 (estimated)
Ages18 Years and up
SexMale
SponsorPfizer Industry-sponsored
Drugs / interventionschemotherapy
Locations241 sites (Chandler, Arizona and 240 other locations)
Trial IDNCT06629779 on ClinicalTrials.gov

What this trial studies

This global, multicenter, randomized Phase 3 study aims to evaluate the effectiveness of PF-06821497 (mevrometostat) in combination with enzalutamide compared to a placebo with enzalutamide in men with metastatic castration-resistant prostate cancer (mCRPC). Participants will be screened and randomized to receive either the investigational drug or placebo alongside standard treatment. The study will include a Screening Phase, Randomization, Treatment Phase, Safety Follow-up, and Long-Term Follow-up to assess the drug's efficacy and safety. Eligible participants must have confirmed prostate cancer and meet specific health criteria.

Who should consider this trial

Good fit: Ideal candidates are men with histologically confirmed adenocarcinoma of the prostate who have not received prior treatment with certain anti-androgens.

Not a fit: Patients with active inflammatory gastrointestinal disease, significant cardiovascular issues, or known brain metastasis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option that improves outcomes for men with metastatic castration-resistant prostate cancer.

How similar studies have performed: Other studies have shown promise with similar approaches, but this specific combination is being evaluated for the first time.

Eligibility criteria

Show full inclusion / exclusion 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:

* 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.

Where this trial is running

Chandler, Arizona and 240 other locations

+191 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Castration-Resistant Prostate CancerMEVROMETOSTATMETASTATIC CASTRATION RESISTANT PROSTATE CANCERPF-06821497EZH2enhancer of zeste homologue-2enzalutamidemCRPC
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.