Идёт набор NCT06256588

A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma

Фаза III С лечением Neoplasms, Head and Neck

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, Placebo.
Кому может быть актуально: Состояния в реестре: Neoplasms, Head and Neck. 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 +26
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 Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate Dostarlimab as Sequential Therapy After Chemoradiation in Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma

Обзор

The goal of this study is to assess the safety and effectiveness of Dostarlimab compared to Placebo in adult participants with Head and Neck Squamous Cell Carcinoma (HNSCC)

Вмешательства

Препарат Dostarlimab
Dostarlimab will be administered as an intravenous (IV) infusion
Препарат Placebo
Placebo will be administered as an IV infusion

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]
Event-free Survival (EFS) assessed by investigator [Срок оценки: Up to approximately 5 years]
Number of Participants with treatment emergent adverse events (TEAEs), Immune-mediated TEAEs, and serious adverse events (SAEs) by severity [Срок оценки: Up to approximately 5 years]
Number of Participants with TEAEs and SAEs leading to dose delays, withdrawals or death [Срок оценки: Up to approximately 5 years]
Number of participants with clinically significant changes in laboratory, vital signs, and safety assessment parameters [Срок оценки: Up to approximately 5 years]
Serum Concentration of Dostarlimab [Срок оценки: Up to approximately 15 months]
Serum Concentration of Dostarlimab at End of Infusion (C-EoI) [Срок оценки: Up to approximately 15 months]
Serum Predose trough concentration (Ctrough) of Dostarlimab [Срок оценки: Up to approximately 15 months]
Number of Participants with Anti-Drug Antibodies against Dostarlimab [Срок оценки: Up to approximately 15 months]

Критерии участия

Критерии включения

Participants are eligible to be included in the study only if all of the following criteria apply:

Has newly diagnosed unresected Locally Advanced (LA) histologically confirmed HNSCC of the oral cavity, oropharynx, hypopharynx or larynx and completed cisplatin plus radiotherapy (termed "CRT" in this protocol) with curative intent and has no evidence of distant metastatic disease.
Has provided acceptable core or excisional biopsy obtained prior to CRT:

PD-L1 positive tumor status
If the primary tumor site is oropharyngeal carcinoma, the participant must have p16 immunohistochemistry (IHC) testing.
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Has adequate organ function.

Критерии исключения

Participants are excluded from the study if any of the following criteria apply:

Has received prior radiation therapy (RT), systemic therapy, targeted therapy, or surgery for management of head and neck cancer not considered part of CRT. Participants receiving induction chemotherapy are excluded. CRT combinations with components other than cisplatin and RT (e.g., experimental agents, including radiosensitizers/radioprotectants, cetuximab) are not eligible.
Has cancer outside of the oropharynx, larynx, hypopharynx or oral cavity, such as nasopharyngeal, sinus, other para-nasal, or other unknown primary head and neck cancer. Has more than one primary HNSCC tumor.
Has experienced any of the following with prior immunotherapy: any immune-related adverse event (irAE) of Grade ≥3, immune-related severe neurologic events of any grade (e.g., myasthenic syndrome/myasthenia gravis, encephalitis, Guillain-Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade (Stevens-Johnson Syndrome, toxic epidermal necrolysis, or Drug Rash with Eosinophilia and Systemic Symptoms \[DRESS\] syndrome), or myocarditis of any grade. Non-clinically significant laboratory abnormalities are not exclusionary.
Has undergone any major surgical procedure or experienced significant traumatic injury that has not resolved by the time of randomization.
Has any history of interstitial lung disease or pneumonitis (past or current).
Has cirrhosis of any stage or current unstable liver biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice.
Has a history or current evidence of any medical condition, therapy, or laboratory abnormality that might confound the study results, interfere with their participation for the full duration of the study intervention, or indicate it is not in the best interest of the participant to participate, in the opinion of the investigator.
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.
Previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or an agent directed to another stimulatory or coinhibitory T-cell receptor \[e.g., Cytotoxic T-lymphocyte associated protein 4 (CTLA4), OX-40, CD137\]
Is pregnant, breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the Screening Visit through 120 days after the last dose of study intervention.
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.

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

Центры проведения

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