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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02609984
First Posted: November 20, 2015
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Immune Design
  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.


Condition Intervention Phase
Sarcoma Myxoid/Round Cell Liposarcoma Synovial Sarcoma Metastatic Sarcoma Recurrent Adult Soft Tissue Sarcoma Locally Advanced Sarcoma Liposarcoma Biological: CMB305 Biological: atezolizumab Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Immune Design:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 88
Study Start Date: October 2015
Estimated Study Completion Date: July 2019
Primary Completion Date: May 26, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combination
CMB305 and atezolizumab
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.
Active Comparator: Control
Atezolizumab
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.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 (<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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609984


Locations
United States, California
Stanford University Medical Center
Palo Alto, California, United States, 94304
Sarcoma Oncology Research Center
Santa Monica, California, United States, 90403
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, District of Columbia
MedStar Washington Hospital Center
Washington, D.C., District of Columbia, United States, 20010
United States, Florida
Mayo Clinic of Jacksonville
Jacksonville, Florida, United States, 32224
United States, Georgia
Georgia Cancer Specialists
Sandy Springs, Georgia, United States, 30342
United States, Illinois
Northwestern University Feinburg School of Medicine
Chicago, Illinois, United States, 60611
United States, Iowa
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 10029
United States, Missouri
Washington University in St. Louis
Saint Louis, Missouri, United States, 63110
United States, New York
Monter Cancer Research
Lake Success, New York, United States, 11042
United States, North Carolina
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Duke Cancer Institute
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Fox Chase cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Vermont
University of Vermont Cancer Center
Burlington, Vermont, United States, 05405
United States, Washington
Scca/Fhcrc
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Immune Design
Genentech, Inc.
  More Information

Responsible Party: Immune Design
ClinicalTrials.gov Identifier: NCT02609984     History of Changes
Other Study ID Numbers: IMDZ-C232
First Submitted: November 14, 2015
First Posted: November 20, 2015
Last Update Posted: July 2, 2017
Last Verified: June 2017

Keywords provided by Immune Design:
immunotherapy
CMB305
LV305
GLA-SE
Atezolizumab
NY-ESO-1

Additional relevant MeSH terms:
Sarcoma
Liposarcoma
Sarcoma, Synovial
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Adipose Tissue
Neoplasms, Connective Tissue
Atezolizumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs