Идёт набор NCT07218380

A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract

Фаза III С лечением Carcinoma, Transitional Cell Urinary Bladder Neoplasms Neoplasm Metastasis

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: Vepugratinib, Placebo, EV, Pembrolizumab.
Кому может быть актуально: Состояния в реестре: Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Neoplasm Metastasis. Базовые параметры: от 18 лет · Все.
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, Бразилия, Канада, Китай +14
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

FORAGER-2: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Vepugratinib Combined With Enfortumab Vedotin and Pembrolizumab in Adults With Untreated Locally Advanced or Metastatic Urothelial Carcinoma With an FGFR3 Genetic Alteration

Обзор

The purpose of this study is to test a new medicine, vepugratinib, in comparison with placebo, to see if it is safe and can help people with a bladder cancer that is advanced or has spread. Vepugratinib or placebo will be administered in combination with enfortumab vedotin and pembrolizumab. Study participation could last up to approximately 6 years.

Вмешательства

Препарат Vepugratinib
Administered orally
Другое Placebo
Administered orally
Препарат EV
Administered by IV infusion
Препарат Pembrolizumab
Administered by IV infusion

Первичные конечные точки

Number of participants with treatment-related adverse events related to vepugratinib in combination with EV and pembrolizumab [Срок оценки: From baseline up to 90 months]
Safety Lead-in: Overall Response Rate (ORR) [Срок оценки: From baseline up to 90 months]
Progression-free Survival (PFS) [Срок оценки: Baseline to Study Completion (estimated as 6 years)]

Вторичные конечные точки (11)

Safety Lead-in: Disease Control Rate (DCR) [Срок оценки: From baseline up to the end of Cycle 2 (each Cycle is 21 days)]
Safety Lead-in: Time to Response (TTR) [Срок оценки: From baseline up to 90 months]
Overall Survival (OS) [Срок оценки: Baseline to Study Completion (estimated as 6 years)]
Objective Response Rate (ORR) by BICR [Срок оценки: Baseline to Study Completion (estimated as 6 years)]
Duration of Response (DoR) [Срок оценки: Baseline to Study Completion (estimated as 6 years)]
Progression-free Survival (PFS) [Срок оценки: Baseline to Study Completion (estimated as 6 years)]
Objective Response Rate (ORR) [Срок оценки: Baseline to Study Completion (estimated as 6 years)]
Duration of Response (DOR) [Срок оценки: Baseline to Study Completion (estimated as 6 years)]
Progression-free Survival 2 (PFS2) [Срок оценки: Baseline to Study Completion (estimated as 6 years)]
Plasma Concentrations of Vepugratinib [Срок оценки: Cycle 1 Day 1 to Study completion (estimated as 90 months)]
Change from Baseline in Global Health Status/Quality of Life (QOL) and Physical Function Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) [Срок оценки: Baseline to Study Completion (estimated as 6 years)]

Критерии участия

Критерии включения

Have histologically confirmed, unresectable locally advanced or metastatic urothelial cancer (mUC). Individuals with mixed histology other than small cell or neuroendocrine carcinoma are eligible if a urothelial component is present.
Have a qualifying fibroblast growth factor receptor 3 (FGFR3) genetic alteration determined via molecular testing from a tumor or blood sample obtained at or any time after diagnosis of advanced or metastatic urothelial cancer.
Have measurable disease by investigator assessment defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Have adequate laboratory parameters

Критерии исключения

Have received prior systemic therapy for locally advanced or metastatic urothelial cancer (mUC).
Have any unresolved toxicities greater than Grade 1 Common Terminology Criteria for Adverse Events (\[CTCAE\] version 5.0) from prior neoadjuvant or adjuvant systemic therapy.
Have ongoing sensory or motor neuropathy of Grade 2 or higher
Have untreated or uncontrolled central nervous system (CNS) involvement or any history of leptomeningeal disease.
Current evidence corneal keratopathy or retinal disorder confirmed by ocular examination at screening.

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