Trial of CMB305 and Atezolizumab in Patients With Sarcoma



Status:Active, not recruiting
Conditions:Cancer, Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/8/2019
Start Date:October 2015
End Date:March 29, 2019

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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

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.

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.

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.
We found this trial at
18
sites
Sandy Springs, Georgia 30342
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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Aurora, Colorado 80045
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Aurora, CO
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Burlington, Vermont 05405
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Burlington, VT
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Charlotte, North Carolina 28211
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Charlotte, NC
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Chicago, IL
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20 Duke Clinic Cir
Durham, North Carolina 27710
(888) 275-3853
Duke Cancer Institute Leading-edge cancer care and research have been a hallmark of Duke Medicine...
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Durham, NC
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Iowa City, IA
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Jacksonville, Florida 32216
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Jacksonville, FL
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Lake Success, New York 11042
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Lake Success, NY
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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Nashville, TN
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Palo Alto, California 94304
Phone: 650-725-6413
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Palo Alto, CA
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Philadelphia, Pennsylvania 19111
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Philadelphia, PA
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Rochester, MN
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Saint Louis, Missouri 63110
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Saint Louis, MO
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Santa Monica, California 90403
Phone: 310-552-9999
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Santa Monica, CA
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Seattle, Washington 98109
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Seattle, WA
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Washington, District of Columbia
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Washington,
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