A Phase 3, Randomized, Double-blind, Placebo-controlled Study For Subjects With Locally-advanced Unresectable or Metastatic Synovial Sarcoma (V943-003, IMDZ-04-1702)
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Keep this study
Lead
Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
The Synovate Study is a global, randomized, double-blind, placebo-controlled, phase 3 study in patients with unresectable, locally-advanced or metastatic New York esophageal squamous cell carcinoma 1 (NY-ESO-1) positive synovial sarcoma following first-line systemic anti-cancer therapy.
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histological diagnosis of synovial sarcoma
Immunohistochemistry (IHC) results from tumor biopsy for New York esophageal squamous cell carcinoma 1 (NY-ESO-1) are positive
Participants have received at least 4 but no more than 8 cycles of first-line anthracycline or ifosfamide-containing systemic anti-cancer therapy regimen
Must have documentation of no evidence of disease progression of the tumor during or after completion of first line systemic anti-cancer therapy
ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1
Age \>/= 12 years
Life expectancy of at least 6 months
You may not be if
Have received last dose of first-line systemic anti-cancer therapy or date of most recent local regional therapy \>28 days prior to day 1
Have received prior anti-NY-ESO-1 therapy
Have received first-line systemic anti-cancer therapy with an agent other than anthracycline or ifosfamide
Have received treatment with systemic immunomodulatory agents within 28 days prior to administration of the first dose of CMB305, or 5 half-lives of the drug, whichever occurs sooner.
Have significant immunosuppression from concurrent, recent, or anticipated need for chronic treatment with systemic immunosuppressive dose of corticosteroids or immunosuppressive medications.
Have psychiatric or other medical illness, or any other condition that in the opinion of the investigator prevents compliance with the study procedures or ability to provide valid informed consent.
Have history of uncontrolled autoimmune disease.
Have a significant electrocardiogram finding or cardiovascular disease
have inadequate organ function per protocol
History of other cancer within 3 years
Evidence of active tuberculosis or recent clinically-significant infection requiring systemic therapy.
Evidence of active Hepatitis B, Hepatitis C, or Human Immunodeficiency virus (HIV) infection
Have a history of brain metastasis
Have received cancer therapies including chemotherapy, radiation, biologic, or kinase inhibitors, granulocyte-colony stimulating factor (G-CSF), or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 3 weeks prior ot the first scheduled dose of CMB305
Female of child bearing potential who is pregnant, is planning to become pregnant, or is breast feeding; or male who is sexually active with a female of child bearing potential who is planning to become pregnant.
Clareo Health | A Phase 3, Randomized, Double-blind, Placebo-controlled Study For Subjects With Locally-advanced Unresectable or Metastatic Synovial Sarcoma (V943-003, IMDZ-04-1702)
