Clinical Trials /

Trial of CMB305 and Atezolizumab in Patients With Sarcoma

NCT02609984

Description:

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.

Related Conditions:
  • Liposarcoma
  • Synovial Sarcoma
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

Trial of CMB305 and <span class="go-doc-concept go-doc-intervention">Atezolizumab</span> in Patients With Sarcoma

Title

  • 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
  • Clinical Trial IDs

    NCT ID: NCT02609984

    ORG ID: IMDZ-C232

    Trial Conditions

    Sarcoma

    Myxoid/Round Cell Liposarcoma

    Synovial Sarcoma

    Metastatic Sarcoma

    Recurrent Adult Soft Tissue Sarcoma

    Locally Advanced Sarcoma

    Liposarcoma

    Trial Interventions

    Drug Synonyms Arms

    Trial Purpose

    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.

    Trial Arms

    Name Type Description Interventions
    Combination Experimental CMB305 and atezolizumab
    Control Active Comparator Atezolizumab

    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, Sjgren's syndrome, Guillain-Barr 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 (<1 week prior to first scheduled dosing)
    clinically significant infection requiring systemic therapy.

    - Evidence of active hepatitis B (HepB), hepatitis C (HepC), or Human Immunodeficiency
    Virus (HIV) infection.

    - Known active or untreated central nervous system (CNS) metastases. - Pregnant,
    planning to become pregnant within 6 months of treatment, or nursing.

    - Known allergy(ies) to any component of CMB305, atezolizumab, or severe allergic
    reactions to monoclonal antibodies, fusion proteins, or CHO cell products.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Progression Free Survival

    Secondary Outcome Measures

    Safety as Evaluated by Adverse Events, Laboratory Findings and Patient Discontinuations

    Progression Free Survival Rates

    Best Overall Response Rate

    Overall Survival

    Trial Keywords

    immunotherapy

    CMB305

    LV305

    GLA-SE

    Atezolizumab

    NY-ESO-1