NCT03520959终止3 期
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Determine the Efficacy and Safety of CMB305 in Unresectable Locally-advanced or Metastatic NY-ESO-1+ Synovial Sarcoma Participants Following First Line Systemic Anti-cancer Therapy (V943-003, IMDZ-04-1702)
Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)55 个研究点 分布在 2 个国家目标入组 1 人开始时间: 2018年9月18日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 55
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
To assess if the CMB305 vaccine regimen may help the body's immune system to slow or stop the growth of synovial sarcoma tumor and improve survival.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Overall Survival (OS)
时间窗: From randomization to date of death, assessed up to 66 months.
OS is defined as the time from randomization to the date of death.
Progression-Free Survival (PFS)
时间窗: From randomization to investigator-determined date of disease progression or death, assessed up to 24 months.
PFS is defined as the time from randomization to the investigator-determined date of disease progression or death, whichever comes first, using Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
次要结局
- Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE)(From randomization to investigator-determined date of disease progression or death, assessed up to approximately 2 months.)
- Quality of Life (QoL): EuroQol 5-Dimension 5 Level (EQ-5D-5L) and EuroQol 5-Dimension Youth (EQ-5D-Y) Questionnaires(From Day 1 up to 12 months)
- Number of Participants Who Discontinued Study Treatment Due to an AE(Up to approximately 2 months)
- Time to Next Treatment (TTNT)(From last dose of CMB305 to initiation of new therapy, assessed up to 24 months.)
- Distant Metastasis Free Survival (DMFS)(From randomization to investigator-determined date of disease progression or death, assessed up to 24 months.)
- Overall Response Rate (ORR)(From randomization to investigator-determined date of disease progression, assessed up to 24 months.)
研究者
研究点 (55)
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