Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-24 @ 2:56 PM
NCT ID:
NCT03520959
Eligibility Criteria:
Selected Inclusion Criteria:
* 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
Selected Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT03520959
Study Brief:
Protocol Section:
NCT03520959