Идёт набор NCT07221149

A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (ROSETTA Gastric-204)

Фаза II / Фаза III С лечением Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

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: Pumitamig, Folfox, Capox, Nivolumab.
Кому может быть актуально: Состояния в реестре: Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma. 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, Аргентина, Австралия, Бразилия, Канада +15
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

ROSETTA Gastric-204: A Blinded, Randomized, Phase 2/3 Study of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

Обзор

The purpose of this study is to evaluate the safety and efficacy of Pumitamig in combination with chemotherapy versus Nivolumab in combination with chemotherapy in participants with previously untreated advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma

Вмешательства

Препарат Pumitamig
Specified dose on specified days
Препарат Folfox
Specified dose on specified days
Препарат Capox
Specified dose on specified days
Препарат Nivolumab
Specified dose on specified days

Первичные конечные точки

Objective Response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment [Срок оценки: Up to 2 years after the last participant is randomized]
Progression Free Survival (PFS) by RECIST v1.1 per blinded independent central review (BICR) [Срок оценки: Up to approximately 33 months]
Overall survival (OS) [Срок оценки: Up to approximately 47 months]

Вторичные конечные точки (7)

PFS by RECIST v1.1 per investigator assessment [Срок оценки: Up to approximately 33 months]
Duration of Response (DOR) (CR or PR) by RECIST v1.1 per investigator assessment [Срок оценки: Up to approximately 33 months]
Time to Response (TTR) (CR or PR) by RECIST v1.1 per investigator assessment [Срок оценки: Up to approximately 33 months]
Disease control (Best Overall Response (BOR) of confirmed CR, confirmed PR, or Stable Disease (SD)) by RECIST v1.1 per investigator assessment [Срок оценки: Up to approximately 33 months]
Recommended dose of Pumitamig for Phase 3 [Срок оценки: Up to approximately 33 months]
Objective response (OR) by RECIST v1.1 per BICR [Срок оценки: Up to approximately 33 months]
DOR by RECIST v1.1 per BICR [Срок оценки: Up to approximately 33 months]

Критерии участия

Критерии включения

Participants must be previously untreated with systemic treatment for advanced/metastatic disease, histologically or cytologically confirmed advanced or metastatic gastric cancer (GC), gastroesophageal junction adenocarcinoma (GEJC) or distal esophageal adenocarcinoma (EAC). GEJ involvement can be confirmed via biopsy, endoscopy, or imaging.
Participants must have a documented programmed cell death-(ligand)1 (PD-L1) ≥ 1 or < 1 status for Phase 2, and document PD-L1 ≥ 1 status for the Phase 3 part of the study.
Participants must have documented human epidermal growth factor receptor 2 (HER2)-negative cancer, as determined according to local guidelines.
Participants must have measurable disease as defined by RECIST v1.1.

Критерии исключения

Participants must not have untreated known central nervous system (CNS) metastases.
Participants must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis, cerebrovascular accident within 6 months prior to randomization, uncontrolled hypertension (≥ 160 systolic, ≥ 100 diastolic mm Hg) despite optimal medical management, or congenital long QT syndrome.
Participants must not have evidence of major coagulation disorders (eg, hemophilia).
Participants must not have a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism within 3 months prior to randomization, unless the participant has been fully treated (eg, inferior vena cava filter placed) and/or adequately anticoagulated on a stable dose.
Participants must not have a history of abdominal fistula or gastrointestinal (GI) perforation within 6 months of randomization.
Participants must not have had major surgery, open biopsy, or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of study intervention.
Other protocol-defined Inclusion/Exclusion criteria apply.

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 · 34 центра

Local Institution - 0284 — Phoenix
Local Institution - 0437 — Los Angeles
University of California, Irvine (UCI) Health - UC Irvine Medical Center — Orange
Local Institution - 0428 — San Francisco
Florida Cancer Specialists - South — Fort Myers
Local Institution - 0433 — Jacksonville
Florida Cancer Specialists - North — St. Petersburg
Local Institution - 0246 — Tampa
… и ещё 26 центров

Китай · 22 центра

Beijing Cancer hospital — Пекин
Fujian Cancer Hospital — Фучжоу
Local Institution - 0232 — Гуанчжоу
The Sixth Affiliated Hospital of Sun Yat-sen University — Гуанчжоу
Guangxi Medical University Affiliated Tumor Hospital — Nanning
Local Institution - 0237 — Харбин
Local Institution - 0282 — Weihui
Local Institution - 0249 — Чжэнчжоу
… и ещё 14 центров

Япония · 15 центров