NCT03864575Unknown2 期
NICE-COMBO: An Open Label Phase II Study Combining Nivolumab and Celecoxib in Patients With Advanced " Cold " Solid Tumors
Cliniques universitaires Saint-Luc- Université Catholique de Louvain1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2019年8月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- objective response rate
研究概览
简要总结
This is an open-label study to evaluate the safety and the anti-tumor activity of the combination of nivolumab and celecoxib.
The total numbers of participants to be enrolled will be up to 68 participants, depending on the investigated dose of celecoxib during the safety run-in phase.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women ≥ 18 years of age.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
- •Measurable disease as per RECIST 1.
- •Adequate renal, hepatic and hematologic functions as defined by laboratory parameters within ≤ 7 days before treatment initiation.
- •Metastases biopsiable on two occasions
- •Recently acquired (within 90 days prior to treatment) tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses. In order to include only IDO1 positive (≥5% expression of tumor cells) and non T-cell infiltrated tumors (<1% T cells infiltrating the tumor bed)
- •Cancer types with an indication of treatment with anti-PD1 antibodies such as
- •Melanoma non BRAF mutated in first line of treatment
- •Melanoma BRAF mutated in first or second line of treatment
- •Lung cancer (NSCLC) in second line of treatment
- •Renal cell Cancer (RCC) in second line of treatment
- •Head and Neck squamous carcinoma (HNSC) after platinum salt based chemotherapy
- •Bladder cancer after platinum salt based chemotherapy
排除标准
- •Active brain metastases or leptomeningeal metastases.
- •Ocular melanoma.
- •Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement therapy, psoriasis not requiring systemic treatment, or other autoimmune condition not expected to recur in the absence of an external trigger are permitted to enroll.
- •Subjects must also meet other study criteria including exclusions for medical history, positive Hep B/C, HIV, and pregnancy tests, and other laboratory criteria.
研究组 & 干预措施
Combination Group
Experimental
Celecoxib 400 mg/d Nivolumab 240 mg q2w
干预措施: Celecoxib 400 mg (Drug)
结局指标
主要结局
objective response rate
时间窗: at week 12 from onset of treatment
To evaluate the objective response rate (ORR) of Celecoxib in combination with anti-PD1 antibodies
次要结局
- Disease control rate (DCR)(at week 12 from onset of treatment)
- Progression-free survival (PFS)(From date of randomization until the date of first documented progression or date of death, whichever comes first, assessed up to 60 months)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(from first dose to day 28 post last dose)
- Overall survival (OS)(From date of randomization until the date of death, assessed up to 60 months)
- Efficacy - Duration of response (DOR)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months)
- Efficacy - Time to response (TTR)(From onset of treatment to response of cancer through study completion, an average of 12 months is expected)
研究者
研究点 (1)
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