A Phase 2, Single-arm Open-label Study of Combination Nivolumab and Ipilimumab Retreatment in Advanced Renal Cell Carcinoma Patients Progressing on Nivolumab Maintenance Therapy After Nivolumab and Ipilimumab Induction
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 21
- 主要终点
- Disease Control Rate (DCR)
研究概览
简要总结
The purpose of the study is to assess the effectiveness of re-induction with Nivolumab combined with ipilimumab.
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
- •Participants and Target Disease Characteristics- -
- •Confirmed disease progression by RECIST 1.1 criteria on nivolumab maintenance after induction with ipilimumab and nivolumab
- •Progress of maintenance treatment of nivolumab by RECIST. Pathology report must be submitted for embedded tissue block or tumor tissue.
- •Age and Reproduction Sexually active males with WOCBP must agree to instructions for contraception and fetal protection.
- •WOCBP need to use contraception throughout the study and for 5 months post treatment.
- •Exclusion Criteria autoimmune disease statement
- •Active central nervous system metastases
- •Participants with an active autoimmune disease, diabetes mellitus, skin disorders, hyperthyroidism requiring hormone treatments are permitted to enroll.
- •Any major surgery 28 days before 1st treatment Concomitant Therapy
- •participants that have received a live vaccine within 30 days of treatment.
- •use of investigational agent or device with in 28 days before first dosage study treatment.
- •Physical and Laboratory Test Findings Allergies and Adverse Drug Reaction Age and Reproduction
排除标准
- 未提供
结局指标
主要结局
Disease Control Rate (DCR)
时间窗: From first dose up to approximately 14 months
Disease Control Rate (DCR) is defined as the percentage of participants who achieve a confirmed best response of complete response (CR), partial response (PR), or stable disease (SD) for at least 6 months after first treatment dose per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.
次要结局
- Overall Survival (OS)(From first dose to the date of death from any cause (up to approximately 14 months))
- Overall Response Rate (ORR)(From first dose and the date of objectively documented progression criteria or the date of subsequent therapy, whichever occurs first (up to approximately 14 months))
- Duration of Response (DOR)(From first dose to the date of the first documented progression or death due to any cause, whichever occurs first (up to approximately 14 months))
- Time to Objective Response (TTR)(From first dose to the first confirmed documented response (up to approximately 14 months))
- Progression Free Survival (PFS)(From first dose to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 14 months))
- The Number of Participants Experiencing Adverse Events (AEs)(From first dose and 100 days after lost dose (up to approximately 14 months))