NCT03022500已完成2 期
Phase II Study of Durvalumab + Tremelimumab in Pulmonary Sarcomatoid Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Response rate (RR)
研究概览
简要总结
To understand efficacy of Durvalumab(MEDI4736)+ Tremelimumab in Metastatic/relapsed pulmonary sarcomatoid carcinoma
详细描述
This is a phase II multi-center, open-label study to evaluate efficacy and safety of durvalumab + tremelimumab combination treatment in patients with pulmonary sarcomatoid carcinoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 20 years
- •Patients with histologically confirmed NSCLC with the histology of sarcomatoid carcinoma (WHO criteria for sarcomatoid carcinoma is used; Carcinoma with spindle and/or giant cells, Pleomorphic carcinoma, Spindle cell carcinoma, Giant cell carcinoma, Carcinosarcoma, pulmonary blastoma. If the NSCLC patients showed sarcomatoid carcinoma histology in re-biopsy sample(so called epithelial-mesenchymal transition (EMT) phenomenon),the patients are eligible)
- •Initial metastatic cases or recurrent cases after curative treatment (any chemotherapy line is allowed)
- •A patient with at least one measurable lesion of which the diameter is confirmed to be ≥ 10mm in spiral CT or multi-detector CT (MD CT), or ≥ 20 mm in conventional CT (it should be used by a consistent method during the study period).
- •If patients have brain metastasis with neurological symptom, they should be stabilized neurologically with prior radiotherapy or surgery for the brain metastasis (no neurologic symptom in progress and without further steroid treatment)
- •Adequate hematologic (neutrophil count ≥ 1,500 cells/mm3, platelets ≥ 100,000 cells/mm3), hepatic (transaminase ≤ upper normal limit(UNL)x2.5, bilirubin level ≤ UNLx1.5), and renal (creatinine ≤ UNL) function
- •A patient with the willingness to comply with the study protocol during the study period and capable of complying with it.
- •A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages - Absolute neutrophil count 1,500 cells/mm3, platelets 100,000 cells/mm3
- •Expected survival ≥ 3 months
- •Female subjects must either be of non-reproductive potential (ie, post-menopausal by history: ≥60 years old and no menses for ≥1 year without an alternative medical cause; or history of hysterectomy, or history of bilateral tubal ligation, or history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry.
排除标准
- •A patient with no measurable disease
- •chronic systemic steroid therapy or on any other form of immunosuppressive medication
- •has received a live-virus vaccination within 30 days of planned treatment start
- •history of diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal carcinomatosis which are known risks factors for bowel perforation
- •active symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis
- •severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb)
- •active autoimmune disease within the past 2 years (NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment -within the past 2 years- are not excluded) or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents
- •prior treatment with any other anti-programmed cell death protein-1 (anti-PD-1), or PD Ligand-1 (PD-L1) or PD Ligand-2 (PD-L2) agent or anti CTLA4 agents (including durvalumab and tremelimumab)
- •active infection requiring therapy
- •history of Human Immunodeficiency Virus (HIV)
- •active Hepatitis B or C (inactive healthy carriers of HBV with appropriate prophylactic antiviral agents are allowed)
- •symptomatic ascites or pleural effusion
- •pneumonitis that has required a course of oral steroids to assist with recovery, or a history of interstitial lung disease
- •pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study
- •History of active tuberculosis
- •History of allogeneic organ transplant. Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab or tremelimumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
- •Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) ≤ 21 days prior to the first dose of study drug
- •History of allogeneic organ transplant
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any subject known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent
- •Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy, whichever is the longer time period
研究组 & 干预措施
durvalumab + tremelimumab
Experimental
Durvalumab: 1.5g Q4W plusTremelimumab: 75mg Q4W up to 4cycle then Durvalumab 750mg Q2W, till PD or unacceptable toxicity.
干预措施: durvalumab + tremelimumab (Drug)
结局指标
主要结局
Response rate (RR)
时间窗: 12 months after the first date of treatment
According to modified RECIST1.1, The duration from the first date of treatment to the date of death from any cause or follow-up
次要结局
- Progression-Free Survival (PFS)(12 months after the first date of treatment)
- Overall Survival (OS)(12 months after the first date of treatment)
- Safety(12 months after the first date of treatment)
研究者
Bhumsuk Keam
Clinical Assistant Professo
Seoul National University Hospital
研究点 (1)
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