Recruiting

Phase 3

MevrometostatA Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.

Sponsor:

Pfizer

Code:

NCT06629779

Conditions

Metastatic Castration-Resistant Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PF-06821497

Placebo

Enzalutamide

Study Details

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.

Conditions

Metastatic Castration-Resistant Prostate Cancer

Study ID

NCT06629779

Start date

Oct 22, 2024

Status verified date

Aug, 2026

Completion date

Nov 30, 2028

Anticipated

Primary completion date

Dec 2, 2026

Anticipated

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

900 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A

Participants will receive PF-06821497 (875 mg) BID (twice daily) + enzalutamide 160 mg QD (once daily)

active comparator: Arm B

Participants will receive Placebo BID (twice daily) + enzalutamide 160 mg QD (once daily)

Interventions

PF-06821497

Oral continuous

Placebo

Oral continuous

Enzalutamide

Oral continuous

Primary outcome measure

Radiographic Progression Free Survival (rPFS) [ Time Frame: Randomization up to approximately 3 years ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations