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Investigating PF-06821497 for men with advanced prostate cancer

A PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF PF-06821497 (MEVROMETOSTAT) IN COMBINATION WITH ENZALUTAMIDE COMPARED WITH ENZALUTAMIDE OR DOCETAXEL IN PARTICIPANTS WITH METASTATIC CASTRATION RESISTANT PROSTATE CANCER PREVIOUSLY TREATED WITH ABIRATERONE ACETATE (MEVPRO-1)

Phase 3 Interventional Pfizer · NCT06551324

This study is testing if a new medicine called PF-06821497, when combined with enzalutamide, can help men with advanced prostate cancer live longer without their cancer getting worse compared to standard treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment600 (estimated)
Ages18 Years and up
SexMale
SponsorPfizer Industry-sponsored
Drugs / interventionschemotherapy
Locations175 sites (Homewood, Alabama and 174 other locations)
Trial IDNCT06551324 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of the investigational medicine PF-06821497 when combined with enzalutamide in men with metastatic castrate-resistant prostate cancer (mCRPC) who have previously been treated with abiraterone acetate. Participants will be randomly assigned to receive either the combination treatment or a physician's choice of second-line therapy, which may include enzalutamide or docetaxel. The primary goal is to assess the radiographic progression-free survival (rPFS) of the combination therapy compared to the standard treatments.

Who should consider this trial

Good fit: Ideal candidates are men with histologically confirmed adenocarcinoma of the prostate who have metastatic disease and have shown disease progression after treatment with abiraterone acetate.

Not a fit: Patients with small cell features of prostate cancer or those with significant comorbidities that may interfere with participation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for men with advanced prostate cancer who have limited options after prior therapies.

How similar studies have performed: Other studies have shown promise with similar combination therapies in treating advanced prostate cancer, indicating potential for success in this approach.

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 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:

  1. Treatment with first-generation antiandrogen agents, if discontinued prior to first dose of study intervention.
  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 within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is shorter).
* Inadequate organ function.

Where this trial is running

Homewood, Alabama and 174 other locations

+125 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 Castrate Resistant Prostate CancerProstate cancerEnhancer of zeste homolog 2castrate resistant prostate cancerHormone resistantMetastatic hormone resistant prostate cancerMetastatic castrate resistant prostate cancerPF-06821497
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.