A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.
Conditions
Metastatic Castration-Resistant Prostate CancerDrugs
PF-06821497, Placebo, EnzalutamideSummary
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.
Locations
38 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
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
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:
* 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/behavior 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;
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.
Study Plan
Arm A
EXPERIMENTAL
Participants will receive PF-06821497 (875 mg) BID (twice daily) + enzalutamide 160 mg QD (once daily)
DRUG:
PF-06821497Description:
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)
To demonstrate that PF-06821497 in combination with enzalutamide is superior to placebo in combination with enzalutamide in prolonging TTPP
Duration of Response (DoR) in measurable soft tissue disease
Time to prostate specific antigen (PSA) progression.
Prostate Specific Antigen Response
Time to initiation of antineoplastic therapy.
Time to initiation of cytotoxic chemotherapy.
Time to first symptomatic skeletal event
Progression free survival on next line of therapy
Incidence of Adverse Events
To assess circulating tumor DNA (ctDNA) at baseline and on treatment to evaluate tumor burden.
To evaluate the PK of PF-06821497 when dosed with enzalutamide
Change from baseline in patient reported pain symptoms per Brief Pain Inventory-Short Form (BPI-SF)
Change from baseline in BPI-SF Item 3 (Worst Pain) at Cycle 7 Day 1 (Week 25)
Change from baseline in health-related quality of life (HRQoL) per Functional Assessment of Cancer Therapy - Prostate (FACT-P)
Change from baseline in patient reported health status per European Quality of Life 5-Dimension 5 Level (EQ-5D-5L)
Symptomatic toxicity as measured by items from the Patient-Reported Outcome CTCAE (PRO-CTCAE)
Time to definitive deterioration in patient-reported health related quality of life (HRQoL) per FACT-P
Timeline
Last Updated
August 7, 2025Start Date
October 8, 2024Today
October 18, 2025Completion Date ( Estimated )
November 30, 2028
Sponsors of this trial
Lead Sponsor
Pfizer