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Eine Studie zu Atezolizumab bei fortgeschrittenen soliden Tumoren
A Study of Atezolizumab in Advanced Solid Tumors
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gut- oder bösartige Neubildung von Körpergewebe (Tumor) -
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Basisinformationen
Sponsor
Hoffmann-La Roche
Phase
Phase 2
Studien-ID
NCT02458638, MO29518, 2015-000269-30
Condition
Tumors
Official Title
An Open-Label, Multicohort, Phase II Study of Atezolizumab in Advanced Solid Tumors
Studienzusammenfassung
The primary efficacy objective for this study is to evaluate non-progression rate (NPR) at 18 weeks in participants with advanced solid tumors treated with atezolizumab, defined as the percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1, or according to disease-specific criteria for prostate cancer and malignant pleural mesothelioma.
Einschlusskriterien
All
≥ 18 Years
No
Inclusion Criteria
- Histologically documented advanced solid tumors that meet protocol-defined cohort specifications, have progressive disease at study entry, and have received at least one line of prior systemic therapy or for which no alternative therapy to prolong survival exists
- Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (preferred) or in freshly cut and unstained slides (exceptional cases) with an associated pathology report for central testing
- Measurable disease as defined by RECIST v1.1 or disease-specific criteria for prostate cancer and malignant pleural mesothelioma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Negative serum pregnancy test result within 14 days prior to study drug among women of childbearing potential
- Life expectancy > 3 months
Exclusion Criteria
- Malignancies other than disease under study within 5 years prior to Day 1 of Cycle 1 except those with a negligible risk of metastasis or death
- Uncontrolled tumor-related pain
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures >/=1 time per month
- History of asymptomatic or symptomatic central nervous system (CNS) metastasis
- Leptomeningeal disease
- Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated but without evidence that disease has been clinically stable for >/=2 weeks prior to Day 1 of Cycle 1
- Pregnant and lactating women
- Significant cardiovascular disease within 3 months prior to Day 1 of Cycle 1
- Severe infection within 4 weeks prior to Day 1 of Cycle 1
- Oral or IV antibiotics within 2 weeks prior to Day 1 of Cycle 1
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or to any component of the atezolizumab formulation
- History of autoimmune disease except treated/stable hypothyroidism, Type 1 diabetes mellitus, and protocol-specified dermatologic conditions
- Active tuberculosis
- Signs or symptoms of infection within 2 weeks prior to Day 1 of Cycle 1
- Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, or anti-programmed cell death-1 (PD-1) or anti-PD-L1 therapeutic antibodies
- Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to Day 1 of Cycle 1, or anticipated requirement for systemic immunosuppressive medications during the trial
Diese Seite fasst Informationen von öffentlichen Studienregister-Websites wie ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com usw. zusammen. Weitere Informationen zu dieser Studie finden Sie auf der Registerkarte „Für medizinische Fachkräfte" oder auf einer der Studienregister-Websites.
Die Informationen stammen direkt von Websites öffentlicher Register wie ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com usw. und wurden nicht modifiziert.
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