Идёт набор NCT06496178

A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients (LiGeR-HN2)

Фаза III С лечением Head and Neck Squamous Cell Carcinoma

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: Petosemtamab, Investigator's Choice, Investigator's Choice, Investigator's Choice.
Кому может быть актуально: Состояния в реестре: Head and Neck Squamous Cell Carcinoma. 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 +19
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 Controlled Study to Evaluate the Efficacy and Safety of Petosemtamab Compared With Investigator's Choice Monotherapy Treatment in Previously Treated Patients With Incurable, Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma

Обзор

Подробное описание

This is a phase 3 open-label, randomized, controlled, multicenter study to compare petosemtamab vs investigator's choice monotherapy in HNSCC patients for the second- and third-line treatment of incurable metastatic/recurrent disease. HNSCC patients must have progressive disease (PD) on or after anti-PD-1 therapy and platinum-containing therapy. Patients treated with platinum-containing therapy only in the adjuvant setting, or in the context of multimodal therapy for locally advanced disease, should have PD within 6 months of the last dose of platinum-containing therapy.

Вмешательства

Препарат Petosemtamab
MCLA-158
Препарат Investigator's Choice
Cetuximab
Препарат Investigator's Choice
Methotrexate
Препарат Investigator's Choice
Docetaxel

Первичные конечные точки

Overall Survival (OS) [Срок оценки: Up to approximately 3 years]

Вторичные конечные точки (12)

Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review [Срок оценки: Up to approximately 2 years]
Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review [Срок оценки: Up to approximately 2 years]
Duration of Response (DOR) as Assessed by Blinded Independent Central Review [Срок оценки: Up to approximately 2 years]
Objective Response Rate (ORR) as Assessed by Investigator Review [Срок оценки: Up to approximately 2 years]
Progression Free Survival (PFS) as Assessed by Investigator Review [Срок оценки: Up to approximately 2 years]
Duration of Response (DOR) as Assessed by Investigator Review [Срок оценки: Up to approximately 2 years]
Time to Response (TTR) as Assessed by Blinded Independent Central Review [Срок оценки: Up to approximately 2 years]
Time to Response (TTR) as Assessed by Investigator Review [Срок оценки: Up to approximately 2 years]
Clinical Benefit Rate (CBR) as Assessed by Blinded Independent Central Review [Срок оценки: Up to approximately 2 years]
Clinical Benefit Rate (CBR) as Assessed by Investigator Review [Срок оценки: Up to approximately 2 years]
Number of Participants who Experienced At Least One Treatment Emergent Adverse Event (TEAE) [Срок оценки: Up to 30 days post-last dose]
Number of Participants who Experienced At Least One Serious TEAE [Срок оценки: Up to 30 days post-last dose]

Критерии участия

Критерии включения

Signed ICF before initiation of any study procedures.
Age ≥ 18 years at signing of ICF.
Histologically previously confirmed HNSCC with evidence of metastatic or locally advanced disease not amenable to standard therapy with curative intent.
HNSCC participants progressed on or after anti-PD-1 therapy and platinum-containing therapy.
The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
Documentation of p16 status (positive or negative) by local laboratory IHC for participants with primary oropharyngeal cancer.
A baseline new tumor sample unless the participant has an available tumor sample as an FFPE block with sufficient material.
Measurable disease as defined by RECIST v1.1 by radiologic methods.
ECOG PS of 0 or 1
Life expectancy ≥ 12 weeks, as per investigator
Adequate organ function (as per protocol)

Критерии исключения

Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 14 days prior to randomization.
Known leptomeningeal involvement
Any systemic anticancer therapy within 4 weeks prior to randomization.
Major surgery within 3 weeks or palliative radiotherapy within 2 weeks prior to randomization.
Persistent Grade >1 clinically significant toxicities related to prior antineoplastic therapies
History of hypersensitivity reaction to any of the excipients of treatment required for this study.
Unstable angina; history of congestive heart failure of Class II-IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment or history of myocardial infarction within 6 months of study entry
History of prior malignancies with the exception of localized cancer with curative resection (e.g. cervical intraepithelial neoplasia or nonmelanoma skin cancer)
Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy
Current serious illness or medical conditions including, but not limited to, uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders
Participants with known infectious diseases (as per protocol)
Pregnant or breastfeeding participants
Participant has a primary tumor site of nasopharynx (any histology).

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