Frontlight ResearchEarly access
Taking people in United StatesPhase 3
Tests mevrometostat with enzalutamide in men with advanced prostate cancer
Tests mevrometostat plus enzalutamide, compared with placebo, in men with advanced prostate cancer.
Key facts
- Who runs it
- Pfizer
- Where
- Anaheim, Bonney Lake, Chandler, Fayetteville, Federal Way, Fountain Valley, Gig Harbor, Gilbert, Glendale, Goodyear, Laguna Hills, Little Rock, Los Angeles, Mesa, Myrtle Beach, Phoenix, Puyallup, Quincy, Rogers, San Antonio, San Diego, Santa Fe, Scottsdale, Seattle, Springdale, Tacoma, and The Bronx, United StatesSee the 36 sitesAlso in 26 other countries, 195 sites
- Trial code
- Registry title
- A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 900 people, planned
- Started
- 22 Oct 2024
- Expected to end
- 30 Nov 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- PF-06821497
- Placebo
- Enzalutamide
- Record updated
- 30 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with prostate cancer that has spread and no longer responds to hormone lowering treatment, and who have not had certain earlier cancer treatments for this stage.
- Age
- 18 years and older
- Sex
- Men only
- Disease stage
- Prostate adenocarcinoma without small cell features, spread to bone or soft tissue, and getting worse despite medical or surgical castration (metastatic castration-resistant).
- Earlier treatment
- Must not have had treatment for this stage such as chemotherapy, radio-ligand therapy, CDK4/6 inhibitors, androgen receptor signaling inhibitors (including enzalutamide, apalutamide, darolutamide) or PARP monotherapy. First-generation antiandrogens, estrogens, progestins and cyproterone acetate are allowed. Docetaxel is allowed for earlier hormone-sensitive disease if the cancer did not progress during or within 3 months of treatment.
Main reasons for not taking part
- Known or suspected brain metastasis or active leptomeningeal disease, or a significant history of seizure
- Clinically significant heart or blood vessel disease
- Active inflammatory bowel disease, chronic diarrhea, or previous stomach removal or lap-band surgery
- Past myelodysplastic syndrome, acute myeloid leukemia, or another cancer (with a few exceptions)
- Inadequate organ function
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- Known history of active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery
- 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:; Treatment with first-generation antiandrogen (ADT) agents, estrogens, progestins, cyproterone acetate; 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)
- 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
- Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that make the participant inappropriate for the study
- Inadequate organ function
Where in United States
Also in 26 other countries, 195 sites
- Los Angeles Cancer Network (LACN)Anaheim, United StatesTaking people
- Northwest Medical Specialties, PLLCBonney Lake, United StatesTaking people
- Ironwood Cancer & Research CentersChandler, United StatesTaking people
- Highlands OncologyFayetteville, United StatesTaking people
- Northwest Medical Specialties, PLLCFederal Way, United StatesTaking people
- Los Angeles Cancer Network (LACN)Fountain Valley, United StatesTaking people
- Northwest Medical Specialties, PLLCGig Harbor, United StatesTaking people
- Ironwood Cancer & Research CentersGilbert, United StatesTaking people
- Ironwood Cancer & Research CentersGlendale, United StatesTaking people
- Los Angeles Cancer Network (LACN)Glendale, United StatesTaking people
- Palo Verde Hematology OncologyGlendale, United StatesTaking people
- Ironwood Cancer & Research CentersGoodyear, United StatesTaking people
- Los Angeles Cancer Network (LACN)Laguna Hills, United StatesTaking people
- Arkansas Urology - Little RockLittle Rock, United StatesTaking people
- Los Angeles Cancer Network (LACN)Los Angeles, United StatesTaking people
- Ironwood Cancer & Research CentersMesa, United StatesTaking people
- AUC Urologists, LLCMyrtle Beach, United StatesTaking people
- Carolina Urologic Research Center, LLCMyrtle Beach, United StatesTaking people
- Grand Strand Medical CenterMyrtle Beach, United StatesTaking people
- Parkway Surgery CenterMyrtle Beach, United StatesTaking people
- Ironwood Cancer & Research CentersPhoenix, United StatesTaking people
- NorthWest Medical Specialties, PLLCPuyallup, United StatesTaking people
- Blessing HospitalQuincy, United StatesTaking people
- Blessing Physician ServicesQuincy, United StatesTaking people
- Highlands OncologyRogers, United StatesTaking people
- USA Clinical TrialsSan Antonio, United StatesTaking people
- Medical Oncology Associates of San DiegoSan Diego, United StatesTaking people
- CHRISTUS St. Vincent Regional Cancer CenterSanta Fe, United StatesTaking people
- Ironwood Cancer & Research CentersScottsdale, United StatesTaking people
- Fred Hutchinson Cancer CenterSeattle, United StatesTaking people
- Harborview Medical CenterSeattle, United StatesTaking people
- University of Washington Medical Center - MontlakeSeattle, United StatesTaking people
- Highlands Oncology GroupSpringdale, United StatesTaking people
- Northwest Medical Specialties PLLCTacoma, United StatesTaking people
- Montefiore Medical CenterThe Bronx, United StatesTaking people
- Montefiore Medical Center - Medical ParkThe Bronx, United StatesTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Arm ATreatment being tested
Participants will receive PF-06821497 (875 mg) BID (twice daily) + enzalutamide 160 mg QD (once daily)
Treatment: PF-06821497 and Enzalutamide
- Arm BExisting treatment, for comparison
Participants will receive Placebo BID (twice daily) + enzalutamide 160 mg QD (once daily)
Treatment: Placebo and Enzalutamide
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF PF-06821497 (MEVROMETOSTAT) WITH ENZALUTAMIDE IN METASTATIC CASTRATION RESISTANT PROSTATE CANCER (MEVPRO-2)
- Plain-language title
- Tests mevrometostat with enzalutamide in men with advanced prostate cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Publications
- Phase III randomized studies of mevrometostat and enzalutamide in metastatic prostate cancer (MEVPRO-1 and MEVPRO-2): trial protocols.Future oncology (London, England), 2026
- Record updated
- 30 October 2026