Идёт набор NCT04991948

Study of Pembrolizumab Treatment After CYAD-101 With FOLFOX Preconditioning in Metastatic Colorectal Cancer

Фаза I С лечением Unresectable Metastatic Colorectal Cancer

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: CYAD-101, FOLFOX, Pembrolizumab.
Кому может быть актуально: Состояния в реестре: Unresectable Metastatic Colorectal Cancer. 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, Бельгия
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

An Open-label, Phase Ib Study to Assess the Safety and Clinical Activity of CYAD-101 Administered Concurrently With FOLFOX Chemotherapy, Followed by Pembrolizumab Treatment, in Patients With Metastatic Colorectal Cancer

Обзор

The purpose of the CYAD-101-002 study is to assess the safety and clinical activity of CYAD-101 in patients with unresectable metastatic colorectal cancer administered concurrently with FOLFOX chemotherapy, followed by pembrolizumab treatment.

Подробное описание

This Study aims to provide insight into whether CYAD-101 administration concurrently with FOLFOX chemotherapy, followed by pembrolizumab treatment might be a treatment option for patients with unresectable metastatic colorectal cancer

Вмешательства

Препарат CYAD-101
Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells
Препарат FOLFOX
5-FU, leucovorin and oxaliplatin
Препарат Pembrolizumab
Humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb)

Первичные конечные точки

The Occurrence of Dose Limiting Toxicities (DLT) during the 'DLT reporting period' [Срок оценки: Up to 73 days post first study treatment administration]
The objective response rate (ORR) at the tumor assessment on Day 94 [Visit 15]) [Срок оценки: Up to 94 days post first study treatment administration]

Критерии участия

Критерии включения

Histologically proven metastatic adenocarcinoma of the colon or rectum.

Confirmed metastatic unresectable adenocarcinoma of the colon or the rectum.
Confirmed non-microsatellite instability high (non-MSI-H)/mismatch-repair proficient (pMMR) tumor status
Unequivocal and measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
Recurrent/progressing disease after at least one line of systemic therapy for metastatic disease which must include FOLFOX chemotherapy
The patient is due to receive FOLFOX chemotherapy
Neurotoxicity less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 from previous chemotherapy.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Adequate organ, hepatic, renal, pulmonary and cardiac functions
Tumor biopsy at screening

Критерии исключения

Any other investigational agent or device within 4 weeks of the first study treatment administration.
Any anticancer agent within 4 weeks of the first study treatment administration
Filgrastim (Granulocyte-Colony-Stimulating Factor \[G-CSF\]) or similar growth factors within 7 days of the first study treatment administration
Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
Prior radiotherapy within 2 weeks prior to the planned day for the first study treatment administration
Major surgery within 4 weeks before the planned day for the first study treatment administration
A live vaccine within 30 days prior to the planned day for the first study treatment administration
Uncontrolled intercurrent illness or serious uncontrolled medical disorder
Patients with history of (non-infectious) pneumonitis that require steroids or has current pneumonitis as assessed by chest imaging within 48 hours prior to first study treatment administration.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет