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Localizador de ensaios clínicos
- IMagyn050
A clinical trial comparing atezolizumab with a placebo when given with chemotherapy (paclitaxel and carboplatin) and bevacizumab in people newly diagnosed with advanced ovarian, fallopian tube or peritoneal cancer.
A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Participants With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Câncer Tumor Neoplasias Peritoneal Neoplasms Câncer do Tubo Uterino Câncer Ovariano
Detalhes básicos
Patrocinador
Hoffmann-La Roche
Fase
Fase 3
Identificador de estudo
NCT03038100, YO39523, 2016-003472-52
Condição
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms
Título
A Phase III, Multicenter, Randomized, Study of Atezolizumab Versus Placebo Administered in Combination With Paclitaxel, Carboplatin, and Bevacizumab to Patients With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Resumo do Estudo
Este é um estudo Fase III, global, duplo-cego, de dois braços e randomizado, desenhado para avaliar a eficácia e a segurança de atezolizumabe administrado com paclitaxel + carboplatina + bevacizumabe em comparação a placebo + paclitaxel + carboplatina + bevacizumabe em pacientes que apresentam câncer Estágio III ou Estágio IV de ovário, da trompa de Falópio ou peritoneal primário, com doença residual macroscópica pós-operatória (ou seja, após cirurgia primária de redução do tumor) ou que serão submetidas à terapia neoadjuvante seguida por cirurgia em intervalo.
Critérios de elegibilidade
Feminino
≥18 Anos
Não
Critérios de Inclusão
- Participants receiving a histologic diagnosis of epithelial ovarian cancer (EOC), peritoneal primary carcinoma, or fallopian tube cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Life expectancy greater than (>) 12 weeks
- For participants who receive therapeutic anticoagulation: stable anticoagulant regimen
- Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen in paraffin blocks (preferred) or at least 20 unstained slides (for detailed tissue requirements at screening)
Critérios de Exclusão
- Received a current diagnosis of borderline epithelial ovarian tumor (formerly tumors of low malignant potential)
- Have recurrent invasive epithelial ovarian, fallopian tube, or primary peritoneal cancer that was treated only with surgery (example [e.g.], participants with Stage IA or Stage IB epithelial ovarian or fallopian tube cancers)
- Have non-epithelial ovarian tumors (e.g., germ cell tumors, sex cord stromal tumors)
- Received prior radiotherapy to any portion of the abdominal cavity or pelvis
- Received prior chemotherapy for any abdominal or pelvic tumor that include neoadjuvant chemotherapy (NACT) for ovarian, primary peritoneal or fallopian tube cancer
- Received any biological and/or targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management and/or treatment of epithelial ovarian or peritoneal primary cancer
- Have synchronous primary endometrial cancer
- Have a prior history of primary endometrial cancer, except: Stage IA cancer; superficial myometrial invasion, without lymphovascular invasion; grade less than (<) 3 or poorly differentiated subtypes, and this includes papillary serous, clear cell or other International Federation of Gynecological Oncologists (FIGO) Grade 3 lesions
- With the exception of non-melanoma skin cancer and other specific malignancies as noted above, other invasive malignancies with any evidence of other cancers present within the last 5 years or previous cancer treatment that contraindicates this protocol therapy
- Have a known hypersensitivity or allergy to biopharmaceutical agents produced in Chinese hamster ovary cells or any component of the atezolizumab and/or bevacizumab formulations
- Undergo major surgical procedure within 28 days prior to first bevacizumab dose, or anticipation of the need for a major surgical procedure during the course of the study except participants who receive NACT and will need interval surgery. This may include but is not limited to laparotomy.
- Have prior allogeneic bone marrow transplantation or solid organ transplant
- Have any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results
- Have any approved or investigational anti-cancer therapy, including chemotherapy or hormonal therapy, with exceptions: Hormone-replacement therapy or oral contraceptives
- Are administered treatment with any other investigational agent or participation in another clinical study with anti-cancer therapeutic intent
- Have core biopsy or other minor surgical procedures within 7 days prior to the first dose of bevacizumab
- Have known sensitivity to any component of bevacizumab
- Have known sensitivity to any component of paclitaxel
- Current treatment with anti-viral therapy for hepatitis B virus (HBV)
- History of leptomeningeal disease
A seguinte informação vem do site ClinicalTrials.gov publicamente disponível e foi editada para leigos.
As informações abaixo se origina a partir do site ClinicalTrials.gov publicamente disponível e não foi modificado.
Results Disclaimer
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Resultados do estudo
IMagyn050_LPS_06MAY2021_FINAL_POR.pdf
(PDF, 1.0 MB)
IMagyn050_Thank you letter_POR
(PDF, 0.5 MB)
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For the latest version of this information please go to www.forpatients.roche.com
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