NCT06629779|RecruitingPhase 3DMCFDA Drug

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

A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF PF-06821497 (MEVROMETOSTAT) WITH ENZALUTAMIDE IN METASTATIC CASTRATION RESISTANT PROSTATE CANCER (MEVPRO-2)

Pfizer ClinicalTrials.gov

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2 other identifiers

C23210032024-511652-40-00

Study Type

interventional

Target

900

Locations

27 countries

Sites

241

Timeline

RegisteredOct 2024

StartedOct 2024

CompletionNov 2028

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

900

participants targeted

Target at P75+ for phase_3

Timeline

31mo left

Started Oct 2024

Typical duration for phase_3

Geographic Reach

27 countries

241 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.1 years study duration

Study Progress38%

Oct 2024Nov 2028

First Submitted

Initial submission to the registry

September 10, 2024

Completed

28 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed

14 days until next milestone

Study Start

First participant enrolled

October 22, 2024

Completed

2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2026

Expected

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2028

Last Updated

May 5, 2026

Status Verified

May 1, 2026

Enrollment Period

2.1 years

First QC Date

September 10, 2024

Last Update Submit

May 4, 2026

Conditions

Metastatic Castration-Resistant Prostate Cancer

Keywords

MEVROMETOSTATMETASTATIC CASTRATION RESISTANT PROSTATE CANCERPF-06821497EZH2enhancer of zeste homologue-2enzalutamidemCRPCProstrate Cancercastrate resistant prostate cancerprostatecancer-study.comefficacysafetypharmacokineticspharmacodynamics

Outcome Measures

Primary Outcomes (1)

Radiographic Progression Free Survival (rPFS)
rPFS is defined as the time from the date of randomization to first objective evidence of radiographic progression as assessed in soft tissue per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or in bone per Prostate Cancer Clinical Trials Working Group 3 (PCWG3) guidelines by BICR, or death, whichever occurs first.
Randomization up to approximately 3 years

Secondary Outcomes (20)

Overall survival (OS)
Randomization up to approximately 5 years
To demonstrate that PF-06821497 in combination with enzalutamide is superior to placebo in combination with enzalutamide in prolonging Time To Pain Progression (TTPP)
Randomization up to approximately 5 years
Objective Response Rate (ORR)
Randomization up to approximately 3 years
Duration of Response (DoR) in measurable soft tissue disease
Randomization up to approximately 3 years.
Time to prostate specific antigen (PSA) progression.
Randomization up to approximately 3 years
+15 more secondary outcomes

Study Arms (2)

Arm A

EXPERIMENTAL

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

Drug: PF-06821497Drug: Enzalutamide

Arm B

ACTIVE COMPARATOR

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

Drug: PlaceboDrug: Enzalutamide

Interventions

PF-06821497DRUG

Oral continuous

Also known as: Mevrometostat

Arm A

PlaceboDRUG

Oral continuous

Arm B

EnzalutamideDRUG

Oral continuous

Also known as: Xtandi

Arm AArm B

Eligibility Criteria

Age18 Years+

Sexmale(Gender-based eligibility)

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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:
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).
Inadequate organ function.

Contact the study team to confirm eligibility.