A PHASE II, RANDOMIZED STUDY OF ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY) ADMINISTERED AS MONOTHERAPY OR IN COMBINATION WITH BEVACIZUMAB VERSUS SUNITINIB IN PATIENTS WITH UNTREATED ADVANCED RENAL CELL CARCINOMA.

F. Hoffmann-La Roche Ltd0 个研究点目标入组 305 人开始时间: 2014年3月13日最近更新: 2019年2月28日

适应症

试验速览

暂无简介。

•- Adult patients >/= 18 years of age
•- Unresectable advanced or metastatic renal cell carcinoma with component of clear cell histology and/or component of sarcomatoid histology that has not been previously treated with any systemic agents, including treatment in the adjuvant setting
•- Measurable disease, as defined by RECIST v1.1 - Adequate hematologic and end-organ function as defined by protocol
•- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 6 months after the last dose of atezolizumab and bevacizumab for patients randomized to Arm A or patients treated with this combination in the crossover treatment phase, or 5 months after the last dose of atezolizumab monotherapy for patients randomized to Arm B, or 30 days after the last dose of sunitinib for patients randomized Arm C.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 250
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•- Radiotherapy for RCC within 28 days prior to Cycle 1, Day 1 with the exception of: Single-fraction radiotherapy given for the indication of pain control
•- Known malignancies or metastasis of the brain or spinal cord or leptomeningeal disease
•- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
•- Uncontrolled hypercalcemia or symptomatic hypercalcemia
•- Malignancies other than RCC within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death, treated with expected curative outcome
•- Life expectancy of < 12 weeks
•- Pregnant and lactating women
•- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
•- History of autoimmune disease (Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study)
•Bevacizumab- and Sunitinib-Specific Exclusions:
•- Inadequately controlled hypertension
•- Prior history of hypertensive crisis or hypertensive encephalopathy

发起方