Идёт набор NCT07164443

A Study of Pasritamig Versus Placebo in Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC)

Фаза III С лечением Metastatic Castration-resistant Prostate Neoplasms

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: Pasritamig, Placebo, Best Supportive Care (BSC).
Кому может быть актуально: Состояния в реестре: Metastatic Castration-resistant Prostate Neoplasms. 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, Австралия, Бельгия, Бразилия, Канада +12
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 Pasritamig (JNJ-78278343), a T Cell Redirecting Agent Targeting Human Kallikrein 2, + Best Supportive Care Versus Best Supportive Care for Metastatic Castration-resistant Prostate Cancer

Обзор

The purpose of this study is to evaluate the overall survival (length of time from the start of study to date of death from any cause) for pasritamig (JNJ-78278343) in combination with best supportive care (BSC) as compared to placebo with BSC in participants with metastatic castration-resistant prostate cancer (mCRPC; a stage of cancer that has spread beyond the prostate gland and is no longer responding to hormone therapies).

Вмешательства

Биопрепарат Pasritamig
Pasritamig will be administrated through IV infusion.
Другое Placebo
Placebo will be administrated through IV infusion.
Препарат Best Supportive Care (BSC)
BSC will be administered at the discretion of the treating physician.

Первичные конечные точки

Overall Survival (OS) [Срок оценки: Up to 2 years and 8 months]

Вторичные конечные точки (9)

Radiographic Progression-free Survival (rPFS) [Срок оценки: Up to 2 years and 8 months]
Time to Symptomatic Progression [Срок оценки: Up to 2 years and 8 months]
Time to Skeletal-Related Event [Срок оценки: Up to 2 years and 8 months]
Progression-Free Survival (PFS) [Срок оценки: Up to 2 years and 8 months]
Time to Prostate Specific Antigen (PSA) Progression [Срок оценки: Up to 2 years and 8 months]
Time to Pain Progression (TTPP) as Assessed by the Brief Pain Inventory-Short Form (BPI-SF) Item 3 Worst Pain in 24 Hours [Срок оценки: Up to 2 years and 8 months]
Time to Deterioration in Fatigue as Assessed by the European Organisation For Research And Treatment of Cancer Quality of Life Questionnaire-Core-30 (EORTC QLQ-C30) Fatigue Scale Score [Срок оценки: Up to 2 years and 8 months]
Number of Participants with Adverse Events (AEs) [Срок оценки: Up to 2 years and 8 months]
Number of Participants with Abnormalities in Clinical Laboratory Assessments [Срок оценки: Up to 2 years and 8 months]

Критерии участия

Критерии включения

Histologically confirmed adenocarcinoma of the prostate
Metastatic castration-resistant prostate cancer (mCRPC): Disease that is metastatic either to bone, any lymph node, or both without clear evidence of other metastatic sites at the time of screening by conventional imaging with computed tomography (CT) or magnetic resonance imaging (MRI) (chest, abdomen, and pelvis) and 99m\^Tc bone scan
PSA greater than or equal to (>=) 2 nanogram per milliliter (ng/mL) at screening
In the opinion of the investigator, the next best treatment option is a clinical trial
Participants should have had all life-prolonging therapies for which they are clinically eligible in the opinion of the investigator and to which they have access. Prior therapies could have been given in any disease setting (not limited to mCRPC). In particular, prior treatment specifications include receipt of the following:

Androgen-receptor pathway inhibitor (ARPI): Must have progressed on at least 1 ARPI and unlikely to benefit from retreatment with another ARPI

Taxanes: Should have received at least 2 previous taxane-based regimens. If a participant has received only 1 taxane regimen, the participant is eligible if:

Cabazitaxel is not available
The participant's physician deems the participant unsuitable to receive a second taxane regimen due to toxicity risk or prior intolerance Note: a taxane-based regimen consists of at least 2 cycles of a taxane (either as a single agent or in combination with other therapies) administered within the same 2-month period. Participants who cannot continue taxane therapy because of a documented Grade>=3 taxane related IRR are eligible for enrollment, even if they received fewer than 2 prior cycles of taxane treatment

Radioligand therapy: Should have been previously treated with at least 1 dose of Prostate-specific membrane antigen (PSMA)-targeted lutetium radioligand therapy (eg, lutetium Lu-177 vipivotide tetraxetan), unless one of the following applies:

PSMA-targeted lutetium radioligand therapy is unavailable, not accessible, or not clinically indicated.
The participant's physician deems the participant unsuitable to receive PSMA-targeted lutetium radioligand therapy.

Polyadenosine diphosphate-ribose polymerase inhibitors (PARPi): Should have been previously treated with PARPi, if the participant has a known germline or somatic BRCA mutation and treatment is available

Prior orchiectomy or medical castration (receiving ongoing ADT with a GnRH analog \[agonist or antagonist\]) prior to the first dose of study treatment and must continue this therapy throughout the treatment phase
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Participants are eligible if they have the following values:

A) eGFR >= 30 milliliters per minute (mL/min) B) Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) less than or equal to (<=) 5 times the Upper Limit of Normal (ULN) C) Serum total bilirubin <= 3 times ULN D) Absolute neutrophil count (ANC) >= 1.0x10\^9/per liter (L) E) Hemoglobin >= 8.0 grams per deciliter (g/dL) F) Platelet count >= 75x10\^9/L

Критерии исключения

Venous thromboembolic events within 1 month prior to the first dose of study treatment; uncomplicated (Grade <= 2) deep vein thrombosis is not exclusionary
Active autoimmune disease within the past 12 months that requires systemic immunosuppressive medications (eg, chronic corticosteroid, methotrexate, or tacrolimus)
Participants with Grade 1 or higher fever (>=38ºC) or active infection requiring systemic treatment within 7 days prior to randomization are ineligible. Participants must be afebrile (<38ºC) at the time of study treatment dosing unless approved by medical monitor
Clinically significant pulmonary compromise, particularly a requirement for supplemental oxygen use (>2 liters per minute (L/min) by nasal cannula) to maintain adequate oxygenation
Prior or concurrent second malignancy (other than the disease under study) for which natural history or treatment could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s)
Any of the following within 6 months prior to first dose of study treatment:

A) Myocardial infarction B) Severe or unstable angina C) Clinically significant ventricular arrhythmias D) Congestive heart failure (New York Heart Association class II to IV) E) Transient ischemic attack F) Cerebrovascular accident

\- Prior treatment with any CD3-directed therapy

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: Двойное слепое
Основная цель: Лечение

Центры проведения

США · 53 центра

University of California at San Diego — La Jolla
Cedars Sinai Medical Center — Los Angeles
Ronald Reagan UCLA Medical Center — Los Angeles
Rocky Mountain Cancer Centers — Aurora
University of Colorado Cancer Center — Aurora
Colorado Clinical Research — Lakewood
Hartford Hospital — Hartford
Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital — Washington D.C.
… и ещё 45 центров

Китай · 15 центров

Peking University First Hospital — Пекин
The First Bethune Hospital of Jilin University — Changchun
… и ещё 13 центров

Япония · 12 центров