Recruiting NCT07028853

This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking Enzalutamide Alone in Participants With mCSPC Who Are ARPI naïve.

Phase III Interventional Metastatic Castration Sensitive Prostate Cancer (mCSPC) Hormone Sensitive Prostate Cancer Prostate Cancer Cancer of the Prostate

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Mevrometostat, Placebo, Enzalutamide.
Who it may be relevant to: Registry conditions: Metastatic Castration Sensitive Prostate Cancer (mCSPC), Hormone Sensitive Prostate Cancer, Prostate Cancer, Cancer of the Prostate. Basic parameters: from 18 years · Male.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Belgium, Brazil +21
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

This study will explore whether a combination of the investigational drug mevrometostat (PF-06821497) and enzalutamide will work better than taking enzalutamide alone in participants with mCSPC who are ARPI naïve and have not yet received chemotherapy in the mCSPC setting.

Detailed description

This is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study evaluating mevrometostat in combination with enzalutamide versus placebo in combination with enzalutamide in participants with mCSPC who have not received systemic anticancer treatments with the exception of androgen-deprivation therapy (ADT) and first-generation antiandrogen agents. Prior therapy with up to 3 months of ADT (chemical or surgical) is allowed, with no radiographic evidence of disease progression or rising PSA levels prior to Day 1.

This study consists of a Screening Phase, Randomization, Treatment Phase, Safety Follow-up, and Long-Term Follow-up. Participants will be randomized on a 1:1 basis to receive (Arm A) mevrometostat (PF-06821497) in combination with enzalutamide, or (Arm B) placebo in combination with enzalutamide.

Interventions

Drug Mevrometostat
Oral continuous
Drug Placebo
Oral continuous
Drug Enzalutamide
Oral continuous

Primary outcome measures

Radiographic Progression Free Survival (rPFS) [Time frame: Randomization up to approximately 4 years]

Secondary outcome measures (12)

Overall survival (OS) [Time frame: Randomization up to approximately 9 years]
Objective response in measurable soft tissue disease [Time frame: Randomization up to approximately 4 years]
Duration of Response (DoR) in measurable soft tissue disease [Time frame: Randomization up to approximately 4 years]
Prostate Specific Antigen Response [Time frame: Randomization up to approximately 4 years]
Time to prostate specific antigen (PSA) progression [Time frame: Randomization up to approximately 4 years]
Time to initiation of antineoplastic therapy [Time frame: Randomization up to approximately 4 years]
Time to first symptomatic skeletal event [Time frame: Randomization up to approximately 4 years]
Time from randomization to CRPC [Time frame: Randomization up to approximately 4 years]
Incidence of Adverse Events [Time frame: Randomization up to approximately 5 years]
To evaluate the PK of mevrometostat when dosed in combination with enzalutamide [Time frame: Cycle 3 Day 1 to last PK draw at Cycle 5 Day 1 (cycle length is 28 days)]
Change from baseline in patient reported pain symptoms per Brief Pain Inventory-Short Form (BPI-SF) [Time frame: Randomization up to approximately 5 years]
Change from baseline in health-related quality of life (HRQoL) per Functional Assessment of Cancer Therapy - Prostate (FACT-P) [Time frame: Randomization up to approximately 5 years]

Eligibility criteria

Inclusion criteria

Male participants aged ≥18 years (or the minimum age of consent in accordance with local regulations) at screening.
Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features.
Metastatic prostate cancer documented by positive bone scan (for bone disease) or metastatic lesion(s) on CT or MRI (for soft tissue/visceral disease).
Resolution of acute effects of any prior therapy to either baseline severity or CTCAE Grade ≤1 (except for AEs which do not constitute a safety risk in the investigator's judgement).
Participants must have ECOG PS 0 or 1.

Exclusion criteria

Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Clinically significant cardiovascular disease.
Known or suspected brain metastasis or active leptomeningeal disease.
Participants must be treatment naïve at the mCSPC stage, eg, participants cannot have received any cytotoxic chemotherapy with the following exceptions: Treatment with first-generation antiandrogen (ADT) agents is allowed for mCSPC.
Previous administration with an investigational product (drug or vaccine) within 30 days.
Use of 5-alpha reductase inhibitors is prohibited within 28 days of randomization.
Prior surgery from which the participant has not fully recovered at least 28 days prior to randomization
Current use or anticipated need for drugs that are known strong CYP3A4/5 inhibitors and inducers (with exception of enzalutamide as part of this study).
Inadequate organ function.
Known allergic or hypersensitivity reactions to mevrometostat or its excipients or to enzalutamide or its excipients.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment