Идёт набор 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.

Фаза III С лечением Metastatic Castration Sensitive Prostate Cancer (mCSPC) Hormone Sensitive Prostate Cancer Prostate Cancer Cancer of the Prostate

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Mevrometostat, Placebo, Enzalutamide.
Кому может быть актуально: Состояния в реестре: Metastatic Castration Sensitive Prostate Cancer (mCSPC), Hormone Sensitive Prostate Cancer, Prostate Cancer, Cancer of the Prostate. Базовые параметры: от 18 лет · Мужчины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Аргентина, Австралия, Бельгия, Бразилия +21
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

Препарат Mevrometostat
Oral continuous
Препарат Placebo
Oral continuous
Препарат Enzalutamide
Oral continuous

Первичные конечные точки

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

Вторичные конечные точки (12)

Overall survival (OS) [Срок оценки: Randomization up to approximately 9 years]
Objective response in measurable soft tissue disease [Срок оценки: Randomization up to approximately 4 years]
Duration of Response (DoR) in measurable soft tissue disease [Срок оценки: Randomization up to approximately 4 years]
Prostate Specific Antigen Response [Срок оценки: Randomization up to approximately 4 years]
Time to prostate specific antigen (PSA) progression [Срок оценки: Randomization up to approximately 4 years]
Time to initiation of antineoplastic therapy [Срок оценки: Randomization up to approximately 4 years]
Time to first symptomatic skeletal event [Срок оценки: Randomization up to approximately 4 years]
Time from randomization to CRPC [Срок оценки: Randomization up to approximately 4 years]
Incidence of Adverse Events [Срок оценки: Randomization up to approximately 5 years]
To evaluate the PK of mevrometostat when dosed in combination with enzalutamide [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Randomization up to approximately 5 years]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение: Рандомизированное
Модель: Параллельные группы
Маскирование: Четверное слепое
Основная цель: Лечение