NCT06629779 A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.
| NCT ID | NCT06629779 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Pfizer |
| Condition | Metastatic Castration-Resistant Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 900 participants |
| Start Date | 2024-10-22 |
| Primary Completion | 2026-12-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 900 participants in total. It began in 2024-10-22 with a primary completion date of 2026-12-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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 in the past year or suicidal behavior in the past 5 years 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, estrogens, progestins, cyproterone acetate; 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.
Contact & Investigator
Pfizer CT.gov Call Center
STUDY DIRECTOR
Pfizer
Frequently Asked Questions
Who can join the NCT06629779 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Metastatic Castration-Resistant Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06629779 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 900 participants.
Is NCT06629779 currently recruiting?
Yes, NCT06629779 is actively recruiting participants. Contact the research team at ClinicalTrials.gov_Inquiries@pfizer.com for enrollment information.
Where is the NCT06629779 trial being conducted?
This trial is being conducted at Chandler, United States, Gilbert, United States, Glendale, United States, Glendale, United States and 11 additional locations.
Who is sponsoring the NCT06629779 clinical trial?
NCT06629779 is sponsored by Pfizer. The principal investigator is Pfizer CT.gov Call Center at Pfizer. The trial plans to enroll 900 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.