Recruiting NCT06629779

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

Phase III Interventional Metastatic Castration-Resistant Prostate Cancer

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: PF-06821497, Placebo, Enzalutamide.
Who it may be relevant to: Registry conditions: Metastatic Castration-Resistant Prostate Cancer. 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, Brazil, Bulgaria, Canada +22
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 PF-06821497 (MEVROMETOSTAT) WITH ENZALUTAMIDE IN METASTATIC CASTRATION RESISTANT PROSTATE CANCER (MEVPRO-2)

Overview

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.

Detailed description

This is a global, multicenter, randomized Phase 3 study evaluating PF-06821497 (mevrometostat) in combination with enzalutamide versus placebo in combination with enzalutamide in participants with mCRPC where no systemic anti-cancer treatments have been initiated after documentation of mCRPC with the exception of ADT (androgen deprivation therapy) and first-generation anti-androgen agents. Prior treatment with any of the ARSi's enzalutamide, darolutamide, apalutamide, or abiraterone acetate, is not permitted in any setting. Chemotherapy is permitted in the castrate sensitive setting.

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) PF-06821497 in combination with enzalutamide, or (Arm B) placebo in combination with enzalutamide.

Interventions

Drug PF-06821497
Oral continuous
Drug Placebo
Oral continuous
Drug Enzalutamide
Oral continuous

Primary outcome measures

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

Secondary outcome measures (12)

Overall survival (OS) [Time frame: 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) [Time frame: Randomization up to approximately 5 years]
Objective Response Rate (ORR) [Time frame: Randomization up to approximately 3 years]
Duration of Response (DoR) in measurable soft tissue disease [Time frame: Randomization up to approximately 3 years.]
Time to prostate specific antigen (PSA) progression. [Time frame: Randomization up to approximately 3 years]
Prostate Specific Antigen Response [Time frame: Randomization up to approximately 3 years.]
Time to initiation of antineoplastic therapy. [Time frame: Randomization up to approximately 5 years.]
Time to initiation of cytotoxic chemotherapy. [Time frame: Randomization up to approximately 5 years]
Time to first symptomatic skeletal event [Time frame: Randomization up to approximately 3 years.]
Progression free survival on next line of therapy [Time frame: Randomization up to approximately 5 years]
Incidence of Adverse Events [Time frame: Randomization up to approximately 5 years]
To assess circulating tumor DNA (ctDNA) at baseline and on treatment to evaluate tumor burden. [Time frame: Baseline up to approximately 3 years.]

Eligibility criteria

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:

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.

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