A Phase 3 Randomized Open Label Study to Compare NKTR-214 Combined With Nivolumab to the Investigator's Choice of Sunitinib or Cabozantinib in Patients With Previously Untreated Advanced Renal Cell Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 623
- 试验地点
- 95
- 主要终点
- Overall Survival (OS) in IMDC All-Risk and Intermediate- or Poor-risk Patients With Previously Untreated Advanced RCC
研究概览
简要总结
The main purpose of this study is to compare the objective response rate (ORR) and overall survival (OS) of bempegaldesleukin (NKTR-214: BEMPEG) combined with nivolumab to that of tyrosine kinase inhibitor (TKI) monotherapy (sunitinib or cabozantinib) in IMDC intermediate- or poor-risk patients and IMDC all-risk patients with previously untreated advanced renal cell carcinoma (RCC).
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
- •Provide written, informed consent to participate in the study and follow the study procedures
- •Karnofsky Performance Status (KPS) of at least 70%
- •Measurable disease per mRECIST 1.1 criteria
- •Histologically confirmed RCC with a clear-cell component (may have sarcomatoid features); advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC
- •Patients with any International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) score (favorable-, intermediate-, or poor-risk) are eligible. At least one IMDC prognostic factor must be present to qualify as either intermediate- or poor-risk renal cell carcinoma.
- •No prior systemic therapy (including neoadjuvant, adjuvant, or vaccine therapy) for RCC
排除标准
- •An active, known or suspected autoimmune disease that has required systemic treatment within the past 3 months (exceptions exist)
- •Patients who have a known additional malignancy that is progressing or requires active treatment (exceptions exist)
- •Any tumor invading the wall of a major blood vessels
- •Any tumor invading the gastrointestinal (GI) tract or any evidence of endotracheal or endobronchial tumor within 28 days prior to randomization
- •Need for >2 medications for management of hypertension (including diuretics)
- •History of pulmonary embolism, deep vein thrombosis (not including tumor thrombus), or clinically significant thromboembolic event within 3 months of randomization
- •Additional protocol defined inclusion/exclusion criteria and exceptions apply
研究组 & 干预措施
Combination of bempegaldesleukin + nivolumab
Patients in Arm A will receive bempegaldesleukin in combination with nivolumab.
干预措施: bempegaldesleukin (Biological)
Combination of bempegaldesleukin + nivolumab
Patients in Arm A will receive bempegaldesleukin in combination with nivolumab.
干预措施: nivolumab (Biological)
sunitinib or cabozantinib
Patients in Arm B will receive the Investigator's choice of either one of two treatment options.
干预措施: sunitinib (Drug)
sunitinib or cabozantinib
Patients in Arm B will receive the Investigator's choice of either one of two treatment options.
干预措施: cabozantinib (Drug)
结局指标
主要结局
Overall Survival (OS) in IMDC All-Risk and Intermediate- or Poor-risk Patients With Previously Untreated Advanced RCC
时间窗: Approximately 32 months
OS is defined as the time from date of first dose to the date of death from any cause. Patients without a date of death were censored at their last known alive date.
Objective Response Rate (ORR) Per mRECIST 1.1 by BICR in IMDC All-risk Patients and Intermediate- or Poor (I/P)-Risk Patients With Previously Untreated Advanced RCC
时间窗: Approximately 32 months
ORR using modified Response Evaluation Criteria in Solid Tumors (mRECIST) 1.1 by Blinded Independent Central Review (BICR) in International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) All-risk patients and intermediate- or poor-risk patients. ORR is defined as the proportion of enrolled participants who achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR is calculated as the sum of CR and PR.
次要结局
- Progression Free Survival (PFS) Per mRECIST 1.1 by BICR in IMDC All-risk Patients and Intermediate- or Poor (I/P)-Risk Patients With Previously Untreated Advanced RCC(Approximately 32 months)