NCT06551324|Active Not RecruitingPhase 3DMCFDA Drug

A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1).

MEVPRO-1

A PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF PF-06821497 (MEVROMETOSTAT) IN COMBINATION WITH ENZALUTAMIDE COMPARED WITH ENZALUTAMIDE OR DOCETAXEL IN PARTICIPANTS WITH METASTATIC CASTRATION RESISTANT PROSTATE CANCER PREVIOUSLY TREATED WITH ABIRATERONE ACETATE (MEVPRO-1)

Pfizer ClinicalTrials.gov

Compare

2 other identifiers

C23210142024-511650-50-00

Study Type

interventional

Target

600

Locations

23 countries

Sites

230

Timeline

RegisteredAug 2024

StartedOct 2024

CompletionOct 2028

Brief Summary

Pfizer MEVPRO-1 (C2321014) is a randomized, open-label, multi-center clinical trial evaluating whether combining the study medicine (PF-06821497) with enzalutamide is safe and effective compared to physician's choice of either second-line androgen receptor (AR) directed therapy with enzalutamide or docetaxel (chemotherapy) for treating metastatic castration-resistant prostate cancer (mCRPC) after progression on prior abiraterone acetate treatment. The primary objective of this clinical trial is to assess the radiographic progression free survival (rPFS) of the combination of PF-06821497 plus enzalutamide versus physician's choice of enzalutamide or docetaxel.

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

600

participants targeted

Target at P75+ for phase_3

Timeline

30mo left

Started Oct 2024

Typical duration for phase_3

Geographic Reach

23 countries

230 active sites

Status

active not 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 years study duration

Study Progress38%

Oct 2024Oct 2028

First Submitted

Initial submission to the registry

July 25, 2024

Completed

19 days until next milestone

First Posted

Study publicly available on registry

August 13, 2024

Completed

2 months until next milestone

Study Start

First participant enrolled

October 21, 2024

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2026

Expected

2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2028

Last Updated

May 5, 2026

Status Verified

May 1, 2026

Enrollment Period

1.7 years

First QC Date

July 25, 2024

Last Update Submit

May 4, 2026

Conditions

Metastatic Castrate Resistant Prostate Cancer (mCRPC)

Keywords

Prostate cancerEnhancer of zeste homolog 2castrate resistant prostate cancerHormone resistantMetastatic hormone resistant prostate cancerMetastatic castrate resistant prostate cancerPF-06821497EnzalutamideDocetaxelAdvanced prostate cancerEfficacySafetyOpen-labelRelapsedrefractory

Outcome Measures

Primary Outcomes (1)

Radiographic Progression Free Survival (rPFS) assessed by blinded independent central review (BICR) per RECIST v1.1 and Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
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 2 years.

Secondary Outcomes (23)

Overall survival (OS)
Randomization up to approximately 4.5 years.
Objective Response (ORR)
Randomization up to approximately 2 years.
Duration of Response (DoR) in measurable soft tissue disease
Randomization up to approximately 2 years.
Time to prostate specific antigen (PSA) progression.
Randomization up to approximately 2 years.
Time to initiation of antineoplastic therapy.
Randomization up to approximately 4.5 years.
+18 more secondary outcomes

Study Arms (2)

Arm A

EXPERIMENTAL

Investigational Arm A: PF-06821497 875 mg twice daily (BID) + enzalutamide 160 mg every day (QD)

Drug: PF-06821497Drug: Enzalutamide

Arm B

ACTIVE COMPARATOR

Comparator Arm B: Physician's choice of enzalutamide 160 mg QD or docetaxel 75 mg/m2 intravenous (IV) every 21 days

Drug: DocetaxelDrug: Enzalutamide

Interventions

PF-06821497DRUG

875 mg BID (2 times a day)

Also known as: Mevrometostat

Arm A

DocetaxelDRUG

75 mg/m2 IV (every 21 days)

Also known as: Taxotere

Arm B

EnzalutamideDRUG

160 mg QD

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 surgical or medical castration with evidence of disease progression on treatment with abiraterone acetate in the mCSPC setting or first line mCRPC setting is required.
Eastern Cooperate Oncology Group (ECOG) performance status 0 - 2, with life expectancy of at least 6 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/behavior or laboratory abnormality that may make the participant inappropriate for the study.
Know 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.
Prior treatment for prostate cancer at any stage with any cytotoxic chemotherapy, radioligand therapy (i.e. 177Lu-PSMA-617, radium 223), androgen receptor signaling inhibitors (ARSi) including enzalutamide, apalutamide, darolutamide, poly ADP-ribose polymerase (PARP) monotherapy, CDK4/6 inhibitors, or other systemic anti-cancer treatment, with the following exceptions:
Treatment with first-generation antiandrogen agents, if discontinued prior to first dose of study intervention.
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.
Use of 5-alpha reductase inhibitors within 28 days of randomization.
Previous administration with an investigational product 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.

Sponsors & Collaborators

Pfizerlead