A Study of Atezolizumab in Advanced Solid Tumors
Condition: Tumors
Intervention: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody
Intervention description: Atezolizumab will be given as IV infusion over 60 minutes on Day 1 of Cycle 1, then over 30 minutes (as tolerated) on Day 1 of each subsequent 3-week cycle.
Intervention MeSH terms: Atezolizumab; Antibodies
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 474.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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