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Trial of CMB305 and Atezolizumab in Patients With Sarcoma

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Disease Information

Descriptive Information
Brief Title † Trial of CMB305 and Atezolizumab in Patients With Sarcoma
Official Title † A Randomized, Open-Label, Phase 2 Trial of CMB305 (Sequentially Administered LV305 and G305) and Atezolizumab in Patients With Locally Advanced, Relapsed, or Metastatic Sarcoma Expressing NY-ESO-1
Brief Summary This is an open-label Phase 2 randomized study that will examine the use of the study agents, CMB305 (sequentially administered LV305 [a dendritic cell-targeting viral vector expressing the NY-ESO-1 gene] and G305 [NY-ESO-1 recombinant protein plus GLA-SE]) in combination with atezolizumab or atezolizumab alone, in patients with locally advanced, relapsed or metastatic sarcoma (synovial or myxoid/round cell liposarcoma) expressing the NY-ESO-1 protein. CMB305 is a novel approach designed to stimulate the body's immune system to fight the spread and growth of cancer in patients whose tumors express the NY-ESO-1 protein. LV305 will be given in a prime-boost approach with G305 to induce a potentially synergistic immunotherapeutic response in combination with atezolizumab.
Detailed Description This study is designed to investigate and examine the time to progression for CMB305 in combination with atezolizumab or atezolizumab alone in the treatment of patients with sarcoma expressing NY-ESO-1 protein.
Study Phase Phase 2
Study Type † Interventional
Study Design †
Primary Outcome Measure † Progression Free Survival
Secondary Outcome Measure † Safety as Evaluated by Adverse Events, Laboratory Findings and Patient Discontinuations
Condition † Sarcoma Myxoid/Round Cell Liposarcoma Synovial Sarcoma Metastatic Sarcoma Recurrent Adult Soft Tissue Sarcoma Locally Advanced Sarcoma Liposarcoma
Intervention † BiologicalCMB305
Study Arms / Comparison Groups Combination CMB305 and atezolizumab Control Atezolizumab
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Biological
Estimated Enrollment † 80
Start Date † October 2015
Completion Date July 2019
Primary Completion Date March 2017
Eligibility Criteria † Selected Inclusion Criteria: - Locally advanced, relapsed, or metastatic sarcoma with measurable tumor burden following therapy, as defined by RECIST v1.1; the total of all lesions must be ≤12 cm (for synovial sarcoma) or ≤15 cm (for myxoid/round cell liposarcoma [MRCL]). - Tumor histology consistent with synovial sarcoma or MRCL. - Tumor specimen positive for NY-ESO-1 expression by IHC. - Inadequate response, relapse, and/or unacceptable toxicity with ≥ 1 prior systemic, surgical, or radiation cancer therapies. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Selected Exclusion Criteria: - Investigational therapy within 4 weeks prior to CMB305 dosing - Prior administration of other NY-ESO-1-targeting immunotherapeutics. - Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti PD-1, and anti PD-L1 therapeutic antibodies, or any other antibody or drug targeting T-cell costimulation. - Treatment with systemic immunostimulatory agents (including but not limited to interleukin-2) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to first dose. - Significant immunosuppression. - Other cancer therapies, including chemotherapy, radiation, biologics or kinase inhibitors within 3 weeks prior to the first scheduled dosing. - History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis - History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), risk of pulmonary toxicity, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted. - History of other cancer within 3 years. - Evidence of active tuberculosis or recent (
Gender All
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts †† Immune Design, 650-887-6703, ClinicalTrials@immunedesign.com
Location Countries † United States
Administrative Information
NCT ID † NCT02609984
Organization ID IMDZ-C232
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Immune Design
Collaborators †† Genentech, Inc.
Investigators † : ,
Information Provided By
Verification Date December 2016
First Received Date † November 14, 2015
Last Updated Date February 28, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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