2022-503105-38-00招募中3 期
SAMETA A Phase III, Open Label, Randomised, 3-Arm, Multi-Centre Study of Savolitinib plus Durvalumab versus Sunitinib and Durvalumab Monotherapy in Participants with MET-Driven, Unresectable and Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (PRCC) (SAMETA)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 54
- 主要终点
- PFS is defined as time from randomisation until disease progression per RECIST 1.1 as assessed by blinded independent central review (BICR), or death due to any cause.
研究概览
简要总结
To demonstrate the effectiveness of savolitinib plus durvalumab relative to sunitinib by assessment of progression-free survival (PFS) in participants with MET-driven, unresectable and locally advanced or metastatic PRCC.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Histologically confirmed unresectable and locally advanced or metastatic PRCC
- •PRCC must be centrally confirmed as MET-driven using a sponsor designated central laboratory validated NGS assay
- •No prior systemic anti-cancer treatment in the metastatic setting; no prior exposure to MET inhibitors, Durvalumab or Sunitinib in any setting
- •Karnofsky Score ≥70
- •At least one lesion, not previously irradiated, that can be accurately measured at baseline
- •Adequate organ and bone marrow function
- •Life expectancy minimum of 12 weeks
- •Adequate coagulation parameters
- •Mandatory provision of an FFPE tumour sample to assess the MET driven PRCC
排除标准
- •History of liver cirrhosis of any origin and clinical stage; or history of other serious liver disease or chronic disease with relevant liver involvement, with or without normal LFTs
- •Spinal cord compression or brain metastases, unless asymptomatic and stable on treatment for at least 14 days prior to study intervention
- •Active or prior cardiac disease (within past 6 months) or clinically significant ECG abnormalities and/or factors/medications that may affect QT and/or QTc intervals
- •Active infection including HIV, TB, HBV and HCV
- •Active or prior documented autoimmune or inflammatory disorders
- •Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention
结局指标
主要结局
PFS is defined as time from randomisation until disease progression per RECIST 1.1 as assessed by blinded independent central review (BICR), or death due to any cause.
PFS is defined as time from randomisation until disease progression per RECIST 1.1 as assessed by blinded independent central review (BICR), or death due to any cause.
次要结局
- a. and b. : 1. OS is defined as time from randomisation until the date of death due to any cause.
- a. and b. : 2. ORR is defined as the proportion of participants who have a complete response (CR) or partial response (PR) as determined by BICR per RECIST 1.1.
- a. and b. : 3. DoR will be defined as the time from the date of first documented response until date of documented progression per RECIST 1.1 as assessed by BICR or death due to any cause.
- a. and b. : 4. DCR at 24 or 48 weeks is defined as the percentage of participants who have a CR or PR or who have stable disease (SD) per RECIST 1.1 as assessed by BICR for at least 23 or 47 weeks, respectively after randomisation.
- a. and b. : 5. PFS2 will be defined as time from randomisation to the earliest of the progression event (following the initial progression), subsequent to the first subsequent therapy or death.
- a. and b. : 6. PFS is defined as time from randomisation until disease progression per RECIST 1.1 as assessed by blinded independent central review (BICR), or death due to any cause.
- c. Time to deterioration and change from baseline in symptoms, functioning, and HRQoL
- d. The measures of interest are as follows: 1. participants randomised to savolitinib plus durvalumab: plasma concentration of savolitinib and its metabolites pre-dose (Ctrough) andpost-dose (C1h and C3h), serum concentration of durvalumab pre-dose (Ctrough) and at the end of infusion (Cmax)
- d.: 2. participants randomised to durvalumab monotherapy: serum concentration of durvalumab pre-dose (Ctrough) and at the end of infusion (Cmax)
研究者
Agathe Cabarrot
Scientific
AstraZeneca AB
研究点 (54)
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