Clinical trial · Interventional
This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking Enzalutamide Alone in Participants With mCSPC Who Are ARPI naïve.
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF MEVROMETOSTAT (PF-06821497) WITH ENZALUTAMIDE IN METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MEVPRO-3)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
This study will explore whether a combination of the investigational drug mevrometostat (PF-06821497) and enzalutamide will work better than taking enzalutamide alone in participants with mCSPC who are ARPI naïve and have not yet received chemotherapy in the mCSPC setting.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of the Prostate | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Hormone Sensitive Prostate Cancer | — | UNRESOLVED | — |
| Metastatic Castration Sensitive Prostate Cancer (mCSPC) | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enzalutamide | Drug | Enzalutamide | ALIAS |
| Mevrometostat | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Participants will receive mevrometostat/PF-06821497 (875 mg) BID (twice daily) + enzalutamide 160 mg QD (once daily)
- interventionNames
- Drug: Mevrometostat
- Drug: Enzalutamide
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- description
- Participants will receive Placebo BID (twice daily) + enzalutamide 160 mg QD (once daily)
- interventionNames
- Drug: Placebo
- Drug: Enzalutamide
Primary outcomes (1)
- measure
- Radiographic Progression Free Survival (rPFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Male participants aged ≥18 years (or the minimum age of consent in accordance with local regulations) at screening. * Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features. * Metastatic prostate cancer documented by positive bone scan (for bone disease) or metastatic lesion(s) on CT or MRI (for soft tissue/visceral disease). * Resolution of acute effects of any prior therapy to either baseline severity or CTCAE Grade ≤1 (except for AEs which do not constitute a safety risk in the investigator's judgement). * Participants must have ECOG PS 0 or 1. Exclusion Criteria * Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. * Clinically significant cardiovascular disease. * Known or suspected brain metastasis or active leptomeningeal disease. * Participants must be treatment naïve at the mCSPC stage, eg, participants cannot have received any cytotoxic chemotherapy with the following exceptions: Treatment with first-generation antiandrogen (ADT) agents is allowed for mCSPC. * Previous administration with an investigational product (drug or vaccine) within 30 days. * Use of 5-alpha reductase inhibitors is prohibited within 28 days of randomization. * Prior surgery from which the participant has not fully recovered at least 28 days prior to randomization * Current use or anticipated need for drugs that are known strong CYP3A4/5 inhibitors and inducers (with exception of enzalutamide as part of this study). * Inadequate organ function. * Known allergic or hypersensitivity reactions to mevrometostat or its excipients or to enzalutamide or its excipients.
References
Publications (0)
Data not yet available