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.
Conditions
Metastatic Castration Sensitive Prostate Cancer (mCSPC), Hormone Sensitive Prostate Cancer, Prostate Cancer, Cancer of the ProstateDrugs
Mevrometostat, Placebo, EnzalutamideSummary
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.
Detailed Description
This is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study evaluating mevrometostat in combination with enzalutamide versus placebo in combination with enzalutamide in participants with mCSPC who have not received systemic anticancer treatments with the exception of androgen-deprivation therapy (ADT) and first-generation antiandrogen agents. Prior therapy with up to 3 months of ADT (chemical or surgical) is allowed, with no radiographic evidence of disease progression or rising PSA levels prior to Day 1.
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) mevrometostat (PF-06821497) in combination with enzalutamide, or (Arm B) placebo in combination with enzalutamide.
Locations
17 locations Found with status Recruiting
Status
- RECRUITING
Central Contacts
- Pfizer CT.gov Call Center
- 1-800-718-1021
- [email protected]
Study Director
- Pfizer CT.gov Call Center
Status
- RECRUITING
Central Contacts
- Pfizer CT.gov Call Center
- 1-800-718-1021
- [email protected]
Study Director
- Pfizer CT.gov Call Center
Status
- RECRUITING
Central Contacts
- Pfizer CT.gov Call Center
- 1-800-718-1021
- [email protected]
Study Director
- Pfizer CT.gov Call Center
Status
- RECRUITING
Central Contacts
- Pfizer CT.gov Call Center
- 1-800-718-1021
- [email protected]
Study Director
- Pfizer CT.gov Call Center
Status
- RECRUITING
Central Contacts
- Pfizer CT.gov Call Center
- 1-800-718-1021
- [email protected]
Study Director
- Pfizer CT.gov Call Center
Status
- RECRUITING
Central Contacts
- Pfizer CT.gov Call Center
- 1-800-718-1021
- [email protected]
Study Director
- Pfizer CT.gov Call Center
Status
- RECRUITING
Central Contacts
- Pfizer CT.gov Call Center
- 1-800-718-1021
- [email protected]
Study Director
- Pfizer CT.gov Call Center
Status
- RECRUITING
Central Contacts
- Pfizer CT.gov Call Center
- 1-800-718-1021
- [email protected]
Study Director
- Pfizer CT.gov Call Center
Status
- RECRUITING
Central Contacts
- Pfizer CT.gov Call Center
- 1-800-718-1021
- [email protected]
Study Director
- Pfizer CT.gov Call Center
Status
- RECRUITING
Central Contacts
- Pfizer CT.gov Call Center
- 1-800-718-1021
- [email protected]
Study Director
- Pfizer CT.gov Call Center
Status
- RECRUITING
Central Contacts
- Pfizer CT.gov Call Center
- 1-800-718-1021
- [email protected]
Study Director
- Pfizer CT.gov Call Center
Status
- RECRUITING
Central Contacts
- Pfizer CT.gov Call Center
- 1-800-718-1021
- [email protected]
Study Director
- Pfizer CT.gov Call Center
Status
- RECRUITING
Central Contacts
- Pfizer CT.gov Call Center
- 1-800-718-1021
- [email protected]
Study Director
- Pfizer CT.gov Call Center
Status
- RECRUITING
Central Contacts
- Pfizer CT.gov Call Center
- 1-800-718-1021
- [email protected]
Study Director
- Pfizer CT.gov Call Center
Status
- RECRUITING
Central Contacts
- Pfizer CT.gov Call Center
- 1-800-718-1021
- [email protected]
Study Director
- Pfizer CT.gov Call Center
Status
- RECRUITING
Central Contacts
- Pfizer CT.gov Call Center
- 1-800-718-1021
- [email protected]
Study Director
- Pfizer CT.gov Call Center
Status
- RECRUITING
Central Contacts
- Pfizer CT.gov Call Center
- 1-800-718-1021
- [email protected]
Study Director
- Pfizer CT.gov Call Center
Eligibility Criteria
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.
* 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.
Study Plan
Arm A
EXPERIMENTAL
Participants will receive mevrometostat/PF-06821497 (875 mg) BID (twice daily) + enzalutamide 160 mg QD (once daily)
DRUG:
MevrometostatDescription:
Oral continuousDRUG:
EnzalutamideDescription:
Oral continuous
Arm B
ACTIVE_COMPARATOR
Participants will receive Placebo BID (twice daily) + enzalutamide 160 mg QD (once daily)
DRUG:
PlaceboDescription:
Oral continuousDRUG:
EnzalutamideDescription:
Oral continuous
Outcome Measures
Primary Outcome Measures
Radiographic Progression Free Survival (rPFS)
Secondary Outcome Measures
Overall survival (OS)
Objective response in measurable soft tissue disease
Duration of Response (DoR) in measurable soft tissue disease
Prostate Specific Antigen Response
Time to prostate specific antigen (PSA) progression
Time to initiation of antineoplastic therapy
Time to first symptomatic skeletal event
Time from randomization to CRPC
Incidence of Adverse Events
To evaluate the PK of mevrometostat when dosed in combination with enzalutamide
Change from baseline in patient reported pain symptoms per Brief Pain Inventory-Short Form (BPI-SF)
Change from baseline in health-related quality of life (HRQoL) per Functional Assessment of Cancer Therapy - Prostate (FACT-P)
Time to definitive deterioration in patient-reported health related quality of life (HRQoL) per FACT-P
Patient-reported outcomes in cancer specific symptoms - time to definitive deterioration
Change from baseline and time to confirmed deterioration in participant-reported fatigue symptoms per BFI
Change from baseline in participant-reported general health status per EQ-5D-5L
To assess circulating tumor DNA (ctDNA) at baseline and on treatment to evaluate tumor burden
Timeline
Last Updated
November 12, 2025Start Date
June 19, 2025Today
January 2, 2026Completion Date ( Estimated )
December 8, 2034
Sponsors of this trial
Lead Sponsor
Pfizer