Prostate Cancer Clinical Trial
A Study of Atezolizumab in Advanced Solid Tumors
Summary
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.
Eligibility Criteria
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
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There are 47 Locations for this study
New York New York, 10027, United States
New York New York, 10065, United States
Cleveland Ohio, 44195, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States
Graz , 8036, Austria
Wien , 1090, Austria
Rio de Janeiro RJ, 20231, Brazil
Porto Alegre RS, 90035, Brazil
Sao Paulo SP, 01246, Brazil
Vancouver British Columbia, V5Z 4, Canada
Toronto Ontario, M5G 2, Canada
Aarhus N , 8200, Denmark
Herlev , 2730, Denmark
Odense C , 5000, Denmark
Helsinki , 00029, Finland
Bordeaux , 33076, France
Lyon , 69373, France
Paris , 75475, France
Villejuif , 94805, France
Hamburg , 20246, Germany
Heidelberg , 69120, Germany
Trier , 54290, Germany
Dublin , 4, Ireland
Dublin , , Ireland
Napoli Campania, 80131, Italy
Milano Lombardia, 20133, Italy
Siena Toscana, 53100, Italy
Amsterdam , 1066 , Netherlands
Rotterdam , 3015 , Netherlands
Utrecht , 3584 , Netherlands
Bergen , 5021, Norway
Oslo , 0310, Norway
Bydgoszcz , 85-79, Poland
Gdańsk , 80-21, Poland
Warszawa , 02-78, Poland
Moscow , 11547, Russian Federation
Saint-Petersburg , 19775, Russian Federation
Pamplona Navarra, 31008, Spain
Barcelona , 08035, Spain
Fribourg , 1708, Switzerland
St. Gallen , 9007, Switzerland
Edirne , 22030, Turkey
Istanbul , 34300, Turkey
Istanbul , 34384, Turkey
Sihhiye/Ankara , 06230, Turkey
Bebington , CH63 , United Kingdom
Southampton , SO16 , United Kingdom
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