Идёт набор NCT07221357

A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer

Фаза II / Фаза III С лечением Untreated, Unresectable, or 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: Pumitamig, FOLFOX, FOLFIRI, Bevacizumab.
Кому может быть актуально: Состояния в реестре: Untreated, Unresectable, or 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, Аргентина, Австралия, Австрия, Бельгия +21
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 CRC-203: A Blinded, Randomized Phase 2/3 Study of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer

Обзор

The purpose of this study is to evaluate the safety and efficacy of pumitamig in combination with chemotherapy versus bevacizumab in combination with chemotherapy in participants with previously untreated, unresectable, or metastatic colorectal cancer

Вмешательства

Препарат Pumitamig
Specified dose on specified days
Препарат FOLFOX
Specified dose on specified days
Препарат FOLFIRI
Specified dose on specified days
Препарат Bevacizumab
Specified dose on specified days
Препарат CAPOX
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 5 years]
Progression Free Survival (PFS) by RECIST v1.1 per blinded independent central review (BICR) [Срок оценки: Up to 5 years]
Overall Survival (OS) [Срок оценки: Up to 5 years]

Вторичные конечные точки (7)

PFS by RECIST v1.1 per investigator assessment [Срок оценки: Up to 5 years]
Duration of Response (DOR) (CR or PR) by RECIST v1.1 per investigator assessment [Срок оценки: Up to 5 years]
Time to Response (TTR) (CR or PR) by RECIST v1.1 per investigator assessment [Срок оценки: Up to 5 years]
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 5 years]
Recommended dose of Pumitamig for Phase 3 [Срок оценки: Up to 5 years]
OR by RECIST v1.1 per BICR [Срок оценки: Up to 5 years]
DOR by RECIST v1.1 per BICR [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

Participant must previously untreated, histologically confirmed recurrent or metastatic colorectal adenocarcinoma, not amenable to curative surgery.
Participant must have no known presence of mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC) per historical results (a validated test should be used).
Participant must have no known presence of the gene that encodes the protein B-Raf (BRAF) V600E mutation per local testing.
Participant must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Критерии исключения

Participant must not have any untreated known central nervous system (CNS) metastases including brain, leptomeningeal and/or spinal cord compression.
Participant must not have any prior malignancy active within the previous 2 years, except for locally curable cancers that have been apparently cured and considered to be of low risk of recurrence.
Participant must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis or cerebrovascular accident within 6 months prior to randomization, uncontrolled hypertension (≥ 160 systolic, and/or ≥ 100 diastolic mm Hg) despite optimal medical management, or congenital long QT syndrome.
Participant must not have prior systemic treatment with an anti-PD-1, anti-programmed death (ligand)-1 (PD-L1), anti-PD-L2, CD137 agonists, or anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways or chemotherapy.
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