已入深夜,您辛苦了!由于当前在线用户较少,发布求助请尽量完整地填写文献信息,科研通机器人24小时在线,伴您度过漫漫科研夜!祝你早点完成任务,早点休息,好梦!

PDIGREE: An adaptive phase III trial of PD-inhibitor nivolumab and ipilimumab (IPI-NIVO) with VEGF TKI cabozantinib (CABO) in metastatic untreated renal cell cancer (Alliance A031704).

医学 内科学 易普利姆玛 舒尼替尼 临床终点 无容量 贝伐单抗 肿瘤科 随机化 临床试验 癌症 依维莫司 卡波扎尼布 免疫疗法 化疗
作者
Tian Zhang,Karla V. Ballman,Atish D. Choudhury,Ronald C. Chen,Colleen Watt,Yujia Wen,Ardaman Shergill,Tyler Zemla,Hamid Emamekhoo,Ulka N. Vaishampayan,Michael J. Morris,Daniel J. George,Toni K. Choueiri
出处
期刊:Journal of Clinical Oncology [Lippincott Williams & Wilkins]
卷期号:39 (6_suppl): TPS366-TPS366 被引量:20
标识
DOI:10.1200/jco.2021.39.6_suppl.tps366
摘要

TPS366 Background: First-line treatment of mRCC has rapidly changed to include IPI-NIVO or CABO, with clinical benefit of each based on the Checkmate 214 and CABOSUN (A031203) trials. Combination immunotherapy with VEGF therapies has shown benefit over sunitinib in the JAVELIN 101 and KEYNOTE 426 trials. It is yet unclear which patients (pts) benefit most from combination immunotherapy-VEGF inhibitors, and the optimal sequence of drugs. Methods: In an adaptive, randomized, multicenter phase III trial (Alliance A031704, PDIGREE), pts start treatment with induction IPI 1 mg/kg and NIVO 3 mg/kg intravenously (IV) once every 3 weeks. Key inclusion criteria include clear cell mRCC, International Metastatic RCC Database Consortium (IMDC) intermediate or poor risk, Karnofsky performance status >70, and no prior treatments for mRCC. Based on 3-month radiographic assessment (after completing IPI-NIVO combination), pts with complete responses (CR) undergo maintenance NIVO 480 mg IV every 4 weeks; pts with progression of disease (PD) switch to CABO 60 mg oral daily; pts with non-CR/non-PD are randomized to NIVO 480 mg IV every 4 weeks versus NIVO 480 mg IV every 4 weeks with CABO 40 mg oral daily. Randomization is stratified by IMDC risk criteria and presence of bone metastases. The primary endpoint of the study is overall survival (OS). We hypothesize that 3-year OS will improve to 70% for NIVO-CABO compared to 60% for NIVO alone; to achieve 85% power with a two-sided alpha of 0.05 and exponential distribution, 696 patients will be randomized. Accounting for 30% patients with either CR or PD, and 5% dropout from toxicity, up to 1046 pts will be enrolled. Key secondary endpoints include progression-free survival, 12-month CR rate, overall response rate based on RECIST 1.1 and iRECIST criteria, and toxicity profiles. Quality of life will be assessed based on the FKSI-19, PROMIS-fatigue, and EQ5D-5L questionnaires. Biomarkers associated with CR, tissue-based and plasma-based biomarkers will be assessed. Updated enrollment through January 2021 will be presented. Clinical trial information: NCT03793166 .

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
刚刚
Lidocaine完成签到,获得积分10
刚刚
希特勒发布了新的文献求助10
3秒前
5秒前
5秒前
1218完成签到 ,获得积分10
8秒前
13秒前
14秒前
苏和杨发布了新的文献求助10
16秒前
nicenice发布了新的文献求助10
16秒前
16秒前
17秒前
18秒前
万能图书馆应助称心嫣娆采纳,获得10
19秒前
20秒前
深情安青应助苏和杨采纳,获得10
21秒前
24秒前
田様应助orange9采纳,获得10
26秒前
完美世界应助然大宝采纳,获得10
27秒前
Arui发布了新的文献求助10
29秒前
30秒前
大模型应助丰富钢铁侠采纳,获得10
30秒前
31秒前
Zhanghh87发布了新的文献求助10
31秒前
32秒前
我是老大应助mellow采纳,获得10
35秒前
momo发布了新的文献求助10
35秒前
dabao应助不喜采纳,获得10
35秒前
贰鸟应助Muhammad采纳,获得10
36秒前
漂亮白枫发布了新的文献求助10
36秒前
39秒前
iNk应助Sky36001采纳,获得20
40秒前
龙金兴完成签到 ,获得积分10
40秒前
43秒前
LYSM应助shangjiaGuo采纳,获得30
44秒前
45秒前
45秒前
Akim应助科研通管家采纳,获得10
46秒前
科研通AI2S应助科研通管家采纳,获得10
46秒前
46秒前
高分求助中
A new approach to the extrapolation of accelerated life test data 1000
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
‘Unruly’ Children: Historical Fieldnotes and Learning Morality in a Taiwan Village (New Departures in Anthropology) 400
Indomethacinのヒトにおける経皮吸収 400
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 370
基于可调谐半导体激光吸收光谱技术泄漏气体检测系统的研究 350
Robot-supported joining of reinforcement textiles with one-sided sewing heads 320
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 3989797
求助须知:如何正确求助?哪些是违规求助? 3531914
关于积分的说明 11255516
捐赠科研通 3270597
什么是DOI,文献DOI怎么找? 1805008
邀请新用户注册赠送积分活动 882181
科研通“疑难数据库(出版商)”最低求助积分说明 809190