Идёт набор NCT05855200

Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer

Фаза III С лечением Colonic Neoplasms Neoplasms, Colon

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: Dostarlimab, CAPEOX, FOLFOX.
Кому может быть актуально: Состояния в реестре: Colonic Neoplasms, Neoplasms, Colon. 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, Бельгия, Бразилия +23
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, Open-Label, Randomized Study of Perioperative Dostarlimab Monotherapy Versus Standard of Care in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer

Обзор

The primary purpose of this study is to evaluate the efficacy of perioperative dostarlimab compared with standard of care (SOC) in participants with untreated T4N0 or Stage III (resectable), defective mismatch repair/ microsatellite instability high (dMMR/MSI-H) colon cancer.

Вмешательства

Биопрепарат Dostarlimab
Dostarlimab will be administered.
Препарат CAPEOX
CAPEOX will be administered.
Препарат FOLFOX
FOLFOX will be administered.

Первичные конечные точки

Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR) [Срок оценки: Up to approximately 5 years]

Вторичные конечные точки (9)

Overall Survival (OS) [Срок оценки: Up to approximately 5 years]
Number of Participants with Pathological Response [Срок оценки: Up to approximately 5 years]
Event-free Survival (EFS) assessed by local assessment [Срок оценки: Up to approximately 5 years]
Number of Participants with treatment emergent adverse events (AEs), serious adverse events (SAEs), Immune-mediated Adverse Event (imAEs), AEs leading to death and AEs leading to discontinuation of study treatment [Срок оценки: Up to approximately 5 years]
Number of Participants with AEs and SAEs by Severity [Срок оценки: Up to approximately 5 years]
Serum Concentration of Dostarlimab [Срок оценки: Predose and End of Infusion (EoI) of Cycle 1 and EoI of Cycle 2 to Cycle 10 (each cycle is of 21 days)]
Serum Concentration of Dostarlimab at End of Infusion (C-EoI) [Срок оценки: End of Infusion (EoI) of Cycle 1 to Cycle 10 (each cycle is of 21 days)]
Serum Predose trough concentration (Ctrough) of Dostarlimab [Срок оценки: Predose of Cycle 1 to Cycle 10 (each cycle is of 21 days)]
Number of Participants with Anti-Drug Antibodies against Dostarlimab [Срок оценки: Up to approximately 5 years]

Критерии участия

Критерии включения

Has untreated pathologically confirmed colon adenocarcinoma
Has resectable colon adenocarcinoma defined as clinically T4N0 or Stage III
Has radiologically evaluable disease
Has a tumor demonstrating the presence of either dMMR status or MSI-H

Критерии исключения

Has distant metastatic disease.
Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of the current diagnosis of colon cancer
Has a tumor that, in the investigator's judgment is causing symptomatic bowel obstruction or otherwise requires urgent/emergent surgery at the time of screening. Participants with a history of colonic obstruction are eligible after obstruction is relieved by a diverting stoma (defunctioning ileostomy or colostomy). Patients with a history of colonic obstruction in the context of current colon cancer diagnosis and treated with colonic stents are not eligible.
Has undergone any major surgical procedure, open biopsy, or experienced significant traumatic injury within 28 days prior to randomization
Has any history of interstitial lung disease or pneumonitis and/or history of radiation induced enteritis.
Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice
Has a history of allogenic stem cell transplantation or organ transplantation
Is receiving any other anticancer or experimental therapy. No other experimental therapies (including but not limited to chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, or other experimental drugs) of any kind are permitted while the participant is receiving study intervention
Is pregnant, breastfeeding, or expecting to conceive children within the projected duration of the study
Has a history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins, or known allergies to dostarlimab, or its excipients, or any components of FOLFOX or CAPEOX

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: Открытое
Основная цель: Лечение