NCT03693573撤回3 期
An Open Label, Phase IIIB, Single Arm, Multicenter Safety Study of Atezolizumab in Combination With Bevacizumab in Untreated Locally Advanced or Metastatic Clear Cell or Non-Clear Cell Renal Cell Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Percentage of Participants with Adverse Events
研究概览
简要总结
Study MO39939 is an open-label, single-arm, multicenter trial in patients with unresectable, locally-advanced or metastatic, clear or non-clear cell renal cell carcinoma (RCC) who have not received prior systemic therapy (who are treatment naïve in either the [neo]adjuvant or advanced/metastatic setting for clear and non-clear cell RCC). The study consists of a Screening Period, a Treatment Period, an End of Treatment Visit occurring approximately 30 days after the last dose of study medication, and a Follow-Up Period of 4 years after last patient enrolled.
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
- •Unresectable, advanced or metastatic RCC with clear cell or non-clear cell histology
- •No prior treatment with active or experimental systemic agents for RCC
- •Measurable and/or non-measurable but evaluable baseline disease per RECIST v1.1
- •Confirmed diagnosis of RCC
- •Karnofsky Performance Score (KPS) ≥ 60
- •Adequate hematologic and end-organ function
- •Patients with asymptomatic CNS metastases are eligible, provided they meet all of the following criteria:
- •Evaluable disease outside the CNS
- •No history of intracranial or spinal cord hemorrhage
- •No evidence of significant vasogenic edema
- •No stereotactic radiation within 7 days or whole-brain radiation or neurosurgical resection within 2 weeks before the start of study treatment
- •Have had a screening CNS radiography ≥ 2 weeks since completion of radiotherapy or surgical resection
- •For women of childbearing potential: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating eggs
- •For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm
排除标准
- •Prior treatment for RCC with active or experimental systemic agents, including treatment in the neoadjuvant or adjuvant setting - Confirmed prior treatment with placebo in the (neo)adjuvant setting is allowed
- •Radiotherapy ongoing at the time of study entry
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) - Patients with indwelling catheters are allowed
- •Uncontrolled or symptomatic hypercalcemia - Patients who are currently receiving bisphosphonate therapy without current hypercalcemia are eligible
- •History of malignancy other than RCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death, such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
- •Life expectancy of < 12 weeks
- •History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan - History of radiation pneumonitis in the radiation field (fibrosis) is permitted
- •Active tuberculosis
- •Significant renal disorder requiring dialysis
- •Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
- •Patients with active hepatitis B or hepatitis C
- •Current treatment with anti-viral therapy for HBV
- •Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
研究组 & 干预措施
Atezolizumab + Bevacizumab
Experimental
Participants will receive atezolizumab in combination with bevacizumab.
干预措施: Atezolizumab (Drug)
Atezolizumab + Bevacizumab
Experimental
Participants will receive atezolizumab in combination with bevacizumab.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Percentage of Participants with Adverse Events
时间窗: Up to 6 years
次要结局
- Overall Survival (OS)(Up to 6 years)
- Progression-Free survival (PFS)(Up to 6 years)
- Overall Response Rate (ORR)(Up to 6 years)
- Disease Control Rate (DCR)(Up to 6 years)
- Duration of Response (DoR)(Up to 6 years)
- Change From Baseline in MD Anderson Symptom Inventory (MDASI) Core and MDASI-RCC Module(Before dosing on Day 1 of each cycle, at the End-of-Treatment visit, and at 3, 6, and 9 months after the End-of-Treatment visit. End-of-Treatment visit occurring approximately 30 days after last cycle treatment date. Each cycle is 21 days.)
- Time to Deterioration of Daily Functioning(Before dosing on Day 1 of each cycle, at the End-of-Treatment visit, and at 3, 6, and 9 months after the End-of-Treatment visit. End-of-Treatment visit occurring approximately 30 days after last cycle treatment date. Each cycle is 21 days.)
- PD-L1 Expression in Tumor Samples From the Tumor Tissue(At baseline)
- Change From Baseline in the Single Item (GP5) of the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (FKSI-19), Version 2(Before dosing on Day 1 of each cycle, at the End-of-Treatment visit, and at 3, 6, and 9 months after the End-of-Treatment visit. End-of-Treatement visit occurring approximately 30 days after last cycle treatment date. Each cycle is 21 days.)
研究者
相似试验
已完成
3 期
A Study of Atezolizumab Plus Nab-Paclitaxel in the Treatment of Unresectable Locally Advanced or Metastatic PD-L1-Positive Triple-Negative Breast CancerTriple-Negative Breast CancerNCT04148911Hoffmann-La Roche184
已完成
3 期
An Open-label, One-arm, Study to Evaluate the Hemodynamic Changes and Safety of Nesiritide for Acute Decompensated Heart FailureHeart DecompensationCongestive Heart FailureNCT00813202Xian-Janssen Pharmaceutical Ltd.41
已完成
3 期
(VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GISTGISTNCT03465722Blueprint Medicines Corporation476
已完成
3 期
4EVER - Efficacy, Safety, Health Economics, Translational Research of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast CancerMetastatic Breast CancerNCT01626222Novartis Pharmaceuticals301
招募中
3 期
JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer SubjectsBreast CancerNCT06079983Jiangsu Alphamab Biopharmaceuticals Co., Ltd400