Phase 1/2 Study to Evaluate the Safety and Preliminary Efficacy of Nivolumab Combined With Daratumumab in Participants With Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 35
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to determine whether a combination of Nivolumab and Daratumumab is safe and effective when treating Pancreatic, Non-Small Cell Lung or Triple Negative Breast Cancers, that have advanced or have spread.
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
- •For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- •Patients with metastatic or advanced solid tumors
- •Women with histologically or cytologically confirmed triple negative breast carcinoma
- •Participants with histologically or cytologically confirmed pancreatic adenocarcinoma
- •Participants with histologically or cytologically confirmed Non Small Cell Lung Cancer (NSCLC)
排除标准
- •Active brain metastases or leptomeningeal metastases.
- •Any serious or uncontrolled medical disorder
- •Prior malignancy active within the previous 3 years
- •Other protocol defined inclusion/exclusion criteria could apply
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: From first dose to 30 days post last dose (up to 34 months)
Number of participants with any grade of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Daratumumab
Number of Participants With Serious Adverse Events (SAEs)
时间窗: From first dose to 30 days post last dose (up to 34 months)
Number of participants with any grade of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Daratumumab
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
时间窗: From first dose to 30 days post last dose (up to 34 months)
Number of participants with laboratory abnormalities in specific liver tests based on US conventional units to determine the safety and tolerability of Nivolumab and Daratumumab. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized: * ALT or AST \> 3 x ULN, \> 5 x ULN, \> 10 x ULN and \> 20 x ULN * Total bilirubin \> 2 x ULN * ALP \> 1.5 x ULN * Concurrent (within 1 day) ALT or AST \> 3 x ULN and total bilirubin \> 1.5 x ULN * Concurrent (within 30 days) ALT or AST \> 3 x ULN and total bilirubin \> 1.5 x ULN * Concurrent (within 1 day) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN * Concurrent (within 30 days) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN
Number of Participants With Laboratory Results of Worst CTC Grade
时间窗: From first dose to 30 days post last dose (up to 34 months)
Number of participants with laboratory test results of worst (CTC v4.0) grades 0-4 to determine the safety and tolerability of Nivolumab and Daratumumab
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
时间窗: From first dose to 30 days post last dose (up to 34 months)
Number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units to determine the safety and tolerability of Nivolumab and Daratumumab. The number of subjects with the following laboratory abnormalities from on-treatment evaluations will be summarized: * TSH value \> ULN and * with baseline TSH value \<= ULN * with at least one FT3/FT4 test value \< LLN within 2-week window after the abnormal TSH test * with all FT3/FT4 test values \>= LLN within 2-week window after the abnormal TSH test * with FT3/FT4 missing within 2-week window after the abnormal TSH test. * TSH \< LLN and * with baseline TSH value \>= LLN * with at least one FT3/FT4 test value \> ULN within 2-week window after the abnormal TSH test * with all FT3/FT4 test values \<= ULN within 2-week window after the abnormal TSH test * with FT3/FT4 missing within 2-week window after the abnormal TSH test
次要结局
- Best Overall Response (BOR)(Up to 36 months)
- Nivolumab Serum Concentrations(From day 1 to follow-up 2 (up to 36 months))
- Objective Response Rate (ORR)(Up to 36 months)
- Progression Free Survival (PFS)(Up to 36 months)
- Daratumumab Serum Concentrations(From day 1 to follow-up 2 (up to 36 months))
- Duration of Response (DOR)(Up to 36 months)
- Percentage of Participants Anti Drug Antibody (ADA) by Positivity(Up to 36 months)