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Набира участници Фаза 2/3 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 2/3 – комбинирано изпитване
Заболявания: Untreated, Unresectable, or Metastatic Colorectal Cancer

Спонсор: Bristol-Myers Squibb

Налично на: БГ
Обобщение
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
Кой може да участва
Inclusion Criteria * 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. Exclusion Criteria * 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, ≥ 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.
Места на провеждане 25
Argentina (1)
Local Institution - 0071
ABB , Buenos Aires F.D.
NOT_YET_RECRUITING
Австралия (1)
Local Institution - 0277
Liverpool , New South Wales
NOT_YET_RECRUITING
Белгия (1)
Local Institution - 0622
Bonheiden , Antwerpen
NOT_YET_RECRUITING
Бразилия (1)
Local Institution - 0267
Curitiba , Paraná
NOT_YET_RECRUITING
Канада (1)
Local Institution - 0550
Calgary , Alberta
NOT_YET_RECRUITING
Chile (1)
Local Institution - 0171
Recoleta , Santiago Metropolitan
NOT_YET_RECRUITING
Китай (1)
Local Institution - 0595
Hefei , Anhui
NOT_YET_RECRUITING
Чехия (1)
Local Institution - 0489
Prague , Praha 10
NOT_YET_RECRUITING
Франция (1)
Local Institution - 0202
Marseille , Bouches-du-Rhône
NOT_YET_RECRUITING
Германия (1)
Local Institution - 0591
Erlangen , Bavaria
NOT_YET_RECRUITING
Унгария (1)
Local Institution - 0203
Veszprém
NOT_YET_RECRUITING
Индия (1)
Local Institution - 0010
Nashik , Dādra and Nagar Haveli and Damān and Diu
NOT_YET_RECRUITING
Италия (1)
Local Institution - 0617
Castellana Grotte , Bari
NOT_YET_RECRUITING
Япония (1)
Local Institution - 0053
Chiba , Chiba
NOT_YET_RECRUITING
Нидерландия (1)
Local Institution - 0173
Eindhoven , North Brabant
NOT_YET_RECRUITING
Полша (1)
Local Institution - 0364
Krakow , Lesser Poland Voivodeship
NOT_YET_RECRUITING
Румъния (1)
Local Institution - 0282
Cluj-Napoca , Cluj
NOT_YET_RECRUITING
Сингапур (1)
Local Institution - 0145
Singapore , Central Singapore
NOT_YET_RECRUITING
Южна Корея (1)
Local Institution - 0406
Seongnam , Gyeonggido
NOT_YET_RECRUITING
Испания (1)
Local Institution - 0163
Badalona , Barcelona [Barcelona]
NOT_YET_RECRUITING
Швеция (1)
Local Institution - 0074
Stockholm , Stockholm County
NOT_YET_RECRUITING
Taiwan (1)
Local Institution - 0301
Kaohsiung Niao Sung Dist , Kaohsiung
NOT_YET_RECRUITING
Турция (1)
Local Institution - 0020
Adana
NOT_YET_RECRUITING
Великобритания (1)
The Christie NHS Foundation Trust
Manchester , Lancashire
САЩ (1)
Local Institution - 0428
Tucson , Arizona
NOT_YET_RECRUITING
Технически детайли
Статус
Набира участници
Фаза
Фаза 2/3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
31.12.2025
Крайна дата
11.03.2034
Регистрационен номер
NCT07221357
Източник
anzctr
Запитване за медицински туризъм

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