Study to Compare the Safety and Efficacy of CMB305 With Atezolizumab to Atezolizumab Alone in Participants With Sarcoma (IMDZ-C232/V943A-002)

Stopped early · Phase 2

Conditions studied: Sarcoma, Myxoid/Round Cell Liposarcoma, Synovial Sarcoma, Metastatic Sarcoma, Recurrent Adult Soft Tissue Sarcoma, Locally Advanced Sarcoma, Liposarcoma

In brief

This is an open-label Phase 2 randomized study that will examine the use of the study agents, CMB305 (sequentially administered LV305 which is a dendritic cell-targeting viral vector expressing the New York Esophageal Squamous Cell Carcinoma 1 gene \[NY-ESO-1\] and G305 which is a NY-ESO-1 recombinant protein plus glucopyranosyl lipid adjuvant-stable emulsion \[GLA-SE\]) in combination with atezolizumab or atezolizumab alone, in participants with locally advanced, relapsed or metastatic sarcoma (synovial or myxoid/round cell liposarcoma) expressing the NY-ESO-1 protein. There is no formal primary hypothesis for this study.

Key facts

Study ID

NCT02609984

Run by

Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

People needed

89

Starts

2015-04-29

Expected to finish

2019-02-06

Last updated by the study team

2020-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Locally advanced, relapsed, or metastatic sarcoma with measurable tumor burden following therapy, as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); 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 immunohistochemistry (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

You may not qualify if…

• 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-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), anti-programmed cell death receptor 1 (PD-1), and anti-programmed cell death ligand (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 computed tomography (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 Chinese hamster ovary (CHO) cell products

Where it is running

• Stanford University Medical Center — Palo Alto, California, United States
• Sarcoma Oncology Research Center — Santa Monica, California, United States
• University of Colorado Cancer Center — Aurora, Colorado, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Mayo Clinic of Jacksonville — Jacksonville, Florida, United States
• Georgia Cancer Specialists — Sandy Springs, Georgia, United States
• Northwestern University Feinburg School of Medicine — Chicago, Illinois, United States
• University of Iowa Hospital and Clinics — Iowa City, Iowa, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Washington University in St. Louis — St Louis, Missouri, United States
• Monter Cancer Research — Lake Success, New York, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• Duke Cancer Institute — Durham, North Carolina, United States
• Fox Chase cancer Center — Philadelphia, Pennsylvania, United States
• Vanderbilt University — Nashville, Tennessee, United States
• University of Vermont Cancer Center — Burlington, Vermont, United States
• Scca/Fhcrc — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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