The purpose of this study is to find out whether mevrometostat in combination with enzalutamide delays cancer progression in people with metastatic castration-resistant prostate cancer (mCRPC) who have previously received enzalutamide, darolutamide, or apalutamide in the metastatic castration-sensitive prostate cancer (mCSPC) or non-metastatic castration-resistant prostate cancer (nmCRPC) setting but have not previously progressed on abiraterone.
Willing and able to provide written informed consent
Age 18 years or older
Diagnosis of prostate cancer (adenocarcinoma) confirmed by tissue sample, without neuroendocrine or small cell features
Currently taking or recently treated with enzalutamide, darolutamide, or apalutamide (within 30 days of screening) and willing to switch to or restart enzalutamide for this study
History of myelodysplastic syndrome, acute myeloid leukemia, or other prior cancer (exceptions: non-melanoma skin cancer, carcinoma in situ, cancers more than 3 years ago with no recurrence, or early-stage cancers with low risk of recurrence)
Any medical or psychiatric condition, including active infection or recent suicidal ideation, that may make study participation unsafe
History of seizure or conditions that may increase seizure risk (e.g., prior stroke, significant brain trauma), or loss of consciousness or transient ischemic attack within 12 months
Untreated brain metastases, spinal cord compression, or clinically significant epidural disease
Single group
Mevrometostat
Drug875 mg oral tablet, taken twice daily with food
Enzalutamide
Drug160 mg oral capsule, taken once daily
Radiographic progression free survival (rPFS)
rPFS by RECIST v1.1 and PCWG3 defined as time from start of study treatment to the earlier of first documentation of objective progressive disease by RECIST v1.1 or PCWG3 or death due to any cause.
Overall Survival (OS)
Overall survival as determined by survival status during study participation. OS is defined as the time from the start of study treatment to the date of death due to any cause.
Proportion of Participants Achieving 50% Decline in PSA (PSA50 Response)
Proportion of participants with detectable PSA values at baseline with a 50% decline in PSA confirmed by a subsequent PSA value obtained ≥3 weeks later.
Time to PSA Progression as Defined by PCWG3
Time from first dose of mevrometostat to the date of a ≥25% increase in PSA over nadir with an absolute increase of ≥2 ng/mL, confirmed by a second consecutive PSA value at ≥3 weeks later.
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Incidence of adverse events characterized by type, severity according to CTCAE version 5.0, timing, seriousness, and relationship to study treatment.
Click on the lead sponsor to view all of their trials.
Prostate Cancer Clinical Trials Consortium
Lead sponsor
Pfizer
Collaborator
Dana-Farber Cancer Institute
Collaborator
Fred Hutchinson Cancer Center
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
