Trials / Recruiting
RecruitingNCT06629779
A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant 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)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 900 (estimated)
- Sponsor
- Pfizer · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This is a global, multicenter, randomized Phase 3 study evaluating PF-06821497 (mevrometostat) in combination with enzalutamide versus placebo in combination with enzalutamide in participants with mCRPC where no systemic anti-cancer treatments have been initiated after documentation of mCRPC with the exception of ADT (androgen deprivation therapy) and first-generation anti-androgen agents. Prior treatment with any of the ARSi's enzalutamide, darolutamide, apalutamide, or abiraterone acetate, is not permitted in any setting. Chemotherapy is permitted in the castrate sensitive setting. This study consists of a Screening Phase, Randomization, Treatment Phase, Safety Follow-up, and Long-Term Follow-up. Participants will be randomized on a 1:1 basis to receive (Arm A) PF-06821497 in combination with enzalutamide, or (Arm B) placebo in combination with enzalutamide.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PF-06821497 | Oral continuous |
| DRUG | Placebo | Oral continuous |
| DRUG | Enzalutamide | Oral continuous |
Timeline
- Start date
- 2024-10-22
- Primary completion
- 2026-12-02
- Completion
- 2028-11-30
- First posted
- 2024-10-08
- Last updated
- 2026-04-16
Locations
241 sites across 27 countries: United States, Argentina, Brazil, Bulgaria, Canada, Chile, China, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Japan, Netherlands, New Zealand, Poland, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06629779. Inclusion in this directory is not an endorsement.