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Trial of CMB305 and Atezolizumab in Patients With Sarcoma (IMDZ-C232)

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ClinicalTrials.gov Identifier: NCT02609984
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : May 20, 2019
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Immune Design

Tracking Information
First Submitted Date  ICMJE November 14, 2015
First Posted Date  ICMJE November 20, 2015
Last Update Posted Date May 20, 2019
Study Start Date  ICMJE October 2015
Actual Primary Completion Date March 29, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2017)
  • Progression Free Survival [ Time Frame: Up to 5 years after first study injection ]
    Progression-free survival (PFS) with CMB305 (sequentially administered LV305 and G305) in combination with atezolizumab or with atezolizumab alone
  • Overall Survival [ Time Frame: Up to 5 years after first study injection ]
    Overall survival (OS) after CMB305 in combination with atezolizumab or with atezolizumab alone
Original Primary Outcome Measures  ICMJE
 (submitted: November 19, 2015)
Progression Free Survival [ Time Frame: Up to 2 years after first study injection ]
Progression-free survival (PFS) with CMB305 (sequentially administered LV305 and G305) in combination with atezolizumab or with atezolizumab alone
Change History Complete list of historical versions of study NCT02609984 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2017)
  • Safety as Evaluated by Adverse Events, Laboratory Findings and Patient Discontinuations [ Time Frame: Up to 2 years after first study injection ]
    Safety of CMB305 in combination with atezolizumab or atezolizumab alone will be assessed by the following measures. Adverse events and serious adverse events,(according to CTCAE v4.03); laboratory findings and patient discontinuations at all timepoints will be evaluated. Study deaths and adverse events (serious and non-serious) that lead to discontinuation will be evaluated.
  • Progression Free Survival Rates [ Time Frame: Up to six months after first study injection ]
    Progression-free survival rates at 3 and 6 months after start of study treatment
  • Best Overall Response Rate [ Time Frame: Up to 2 years after first study injection ]
    Best overall response rate (ORR; by Response Evaluation Criteria in Solid Tumors [RECIST] v1.1 modified to use immune-related Response Criteria [irRC]) and response duration up to 24 months after starting treatment
Original Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2015)
  • Safety as Evaluated by Adverse Events, Laboratory Findings and Patient Discontinuations [ Time Frame: Up to 2 years after first study injection ]
    Safety of CMB305 in combination with atezolizumab or atezolizumab alone will be assessed by the following measures. Adverse events and serious adverse events,(according to CTCAE v4.03); laboratory findings and patient discontinuations at all timepoints will be evaluated. Study deaths and adverse events (serious and non-serious) that lead to discontinuation will be evaluated.
  • Progression Free Survival Rates [ Time Frame: Up to six months after first study injection ]
    Progression-free survival rates at 3 and 6 months after start of study treatment
  • Best Overall Response Rate [ Time Frame: Up to 2 years after first study injection ]
    Best overall response rate (ORR; by Response Evaluation Criteria in Solid Tumors [RECIST] v1.1 modified to use immune-related Response Criteria [irRC]) and response duration up to 24 months after starting treatment
  • Overall Survival [ Time Frame: Up to 2 years after first study injection ]
    Overall survival (OS) after CMB305 in combination with atezolizumab or with atezolizumab alone
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of CMB305 and Atezolizumab in Patients With Sarcoma
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sarcoma
  • Myxoid/Round Cell Liposarcoma
  • Synovial Sarcoma
  • Metastatic Sarcoma
  • Recurrent Adult Soft Tissue Sarcoma
  • Locally Advanced Sarcoma
  • Liposarcoma
Intervention  ICMJE
  • Biological: CMB305
    CMB305 is a sequential combination of two investigational study agents, LV305 and G305, with each agent given at different times over several weeks or months.
  • Biological: atezolizumab
    Atezolizumab is known as a checkpoint inhibitor (CPI) or immune checkpoint controller. It is a programmed cell death ligand 1 (PD-L1) inhibitor also known as MPDL3280A.
Study Arms  ICMJE
  • Experimental: Combination
    CMB305 and atezolizumab
    Interventions:
    • Biological: CMB305
    • Biological: atezolizumab
  • Active Comparator: Control
    Atezolizumab
    Intervention: Biological: atezolizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 29, 2017)
88
Original Estimated Enrollment  ICMJE
 (submitted: November 19, 2015)
80
Actual Study Completion Date  ICMJE March 29, 2019
Actual Primary Completion Date March 29, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 (<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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02609984
Other Study ID Numbers  ICMJE IMDZ-C232
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Immune Design
Study Sponsor  ICMJE Immune Design
Collaborators  ICMJE Genentech, Inc.
Investigators  ICMJE Not Provided
PRS Account Immune Design
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP