NCT03768531撤回2 期
Safety and Tolerability Study of Combination Nivolumab and Cabiralizumab as Neoadjuvant and Adjuvant Therapy for Resectable Biliary Tract Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Number of participants experiencing study drug-related toxicities
研究概览
简要总结
The purposed of this research is to study the safety and clinical activity of the combination of nivolumab and cabiralizumab in people with resectable biliary tract cancers (BTC).
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has confirmed biliary tract cancer
- •Ability to understand and willingness to sign a written informed consent document.
- •Age ≥18 years
- •Have biopsiable disease
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Patient must have adequate organ function defined by the study-specified laboratory tests.
- •Must use acceptable form of birth control while on study.
排除标准
- •Has active autoimmune disease that requires systemic treatment.
- •Has a known additional malignancy that is progressing or has required active treatment within the past 2 years or that is expected to require active treatment within two years.
- •Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, etc.).
- •Has known central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
- •Has evidence of an uncontrolled, active infection requiring parenteral anti-bacterial, anti-viral or anti-fungal therapy ≤ 7 days prior to administration of study medication.
- •Has received a blood transfusion within 72 hours prior to first dose of study drug administration
- •Unwilling or unable to follow the study schedule for any reason.
- •Major surgery within 4 weeks prior to initiation of study treatment.
- •Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant muscle disorders or psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant or breastfeeding women.
- •Have known history of infection with HIV, hepatitis B, or hepatitis C.
- •Received any prophylactic vaccine within 30 days of first dose of study drug treatment.
- •Has a history of allergy to study treatments or any of its components of the study.
研究组 & 干预措施
Arm A: Nivolumab
Experimental
干预措施: Nivolumab (Drug)
Arm B: Nivolumab and Cabrilizumab
Experimental
Nivolumab 3 mg/kg will be given intravenously (IV) through a vein in the arm over 30 minutes, a 30 minute rest, followed by cabiralizumab every 2 weeks. (Cycle length 2 weeks).
干预措施: Nivolumab (Drug)
Arm B: Nivolumab and Cabrilizumab
Experimental
Nivolumab 3 mg/kg will be given intravenously (IV) through a vein in the arm over 30 minutes, a 30 minute rest, followed by cabiralizumab every 2 weeks. (Cycle length 2 weeks).
干预措施: Cabrilizumab (Drug)
结局指标
主要结局
Number of participants experiencing study drug-related toxicities
时间窗: 4 years
Number of participants experiencing drug-related adverse events as defined by CTCAE v5.0
次要结局
- Disease free survival (DFS)(up to 4 years)
- Overall survival (OS)(4 years)
研究者
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