ADaptiVe Biomarker Trial That InformS Evolution of Therapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Number of participants with qualified tumor biopsy specimen at baseline
研究概览
简要总结
The purpose of this study is to evaluate the treatment of solid tumors with various immunotherapy combinations. The treatment will be determined based upon a broad biomarker assessment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have an ECOG performance status of less than or equal to 1
- •Participants must have had prior therapy;Participants who have received adjuvant or neoadjuvant anti-PD(L)1 therapy andprogressed within 6 months of completing therapy will be considered IO refractory.
- •Participants must have at least 2 lesions with measurable disease as defined by RECIST Version 1.1
排除标准
- •Participants with suspected, known, or progressive CNS metastases, have untreated CNS metastases, or have the CNS as the only site of disease
- •Participants with carcinomatous meningitis
- •Participants with other active malignancy requiring concurrent intervention
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Arm B
Combination therapy determined by biomarker assessment
干预措施: Nivolumab (Biological)
Arm B
Combination therapy determined by biomarker assessment
干预措施: Relatlimab (Biological)
Arm C
Combination therapy determined by biomarker assessment
干预措施: Nivolumab (Biological)
Arm C
Combination therapy determined by biomarker assessment
干预措施: Cabiralizumab (Biological)
Arm D
Combination therapy determined by biomarker assessment
干预措施: Nivolumab (Biological)
Arm D
Combination therapy determined by biomarker assessment
干预措施: Ipilimumab (Biological)
Arm F
Combination therapy determined by biomarker assessment
干预措施: Nivolumab (Biological)
Arm F
Combination therapy determined by biomarker assessment
干预措施: IDO1 Inhibitor (Drug)
Arm G
Combination therapy determined by biomarker assessment
干预措施: Nivolumab (Biological)
Arm G
Combination therapy determined by biomarker assessment
干预措施: Radiation Therapy (Radiation)
结局指标
主要结局
Number of participants with qualified tumor biopsy specimen at baseline
时间窗: Up to 28 days
An adequate quality tumor biopsy providing sufficient information prior to choosing a combination immunotherapy/Stereotactic Body Radiation Therapy (SBRT)
次要结局
- Percent of change from baseline in histopathologic features(Up to 4 years)
- Percent of change from baseline in biomarker expression patterns(Up to 4 years)
- Number of Serious Adverse Events (SAEs)(Up to 4 years)
- Number of Adverse Events(AEs) leadind to discontinutaion(up to 4 years)
- Number of Adverse Events (AEs)(Up to 4 years)
- Number of Laboratory Abnormalities(Up to 4 years)
- Number of Deaths(up to 4 years)