Health Trials

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

ConditionMetastatic Castration-Resistant Prostate Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorPfizer

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • PF-06821497

    Drug

    Oral continuous

  • Placebo

    Drug

    Oral continuous

  • Enzalutamide

    Drug

    Oral continuous

Treatment groups

900 Participants
are divided into 2 treatment groups
Group A: Arm AExperimental treatment 2 interventions
Group B: Arm BActive comparator 2 interventions

Trial outcomes

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.

Time frame
Randomization up to approximately 3 years

Secondary outcomes

1

Overall survival (OS)

OS is defined as the time from the date of randomization to the date of death due to any cause.

Time frame
Randomization up to approximately 5 years
2

To demonstrate that PF-06821497 in combination with enzalutamide is superior to placebo in combination with enzalutamide in prolonging Time To Pain Progression (TTPP)

TTPP (alpha protected): assessed using time to first ≥2-point increase from baseline score on BPI-SF Item 3 (Worst Pain) observed at 2 consecutive visits or the initiation of short- or long-acting opioid use for pain

Time frame
Randomization up to approximately 5 years
3

Objective Response Rate (ORR)

The objective response rate is defined as the proportion of participants with measurable soft tissue disease at baseline who have a confirmed objective response of complete response (CR) or partial response (PR) per RECIST v1.1 by BICR

Time frame
Randomization up to approximately 3 years
4

Duration of Response (DoR) in measurable soft tissue disease

The DoR is defined as the time from the first objective evidence of soft tissue response (CR or PR, whichever is earlier) to radiographic progression per BICR or death due to any cause whichever occurs first.

Time frame
Randomization up to approximately 3 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pfizer

Lead sponsor

Source ClinicalTrials.gov
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