A Study of Atezolizumab in Advanced Solid Tumors
Status: | Active, not recruiting |
---|---|
Conditions: | Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/31/2019 |
Start Date: | July 13, 2015 |
End Date: | December 13, 2019 |
An Open-Label, Multicohort, Phase II Study of Atezolizumab in Advanced Solid Tumors
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.
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.
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
We found this trial at
6
sites
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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